Aesthetic Dermatology

SAN DIEGO – Color coding reference marks on a specimen and a Mohs map preserves orientation, no matter what happens on the way to the microscope, according to Dr. Howard Steinman.

Reference marks, he explained, are small nicks made with a scalpel, sutures, or staples that serve as extensions of imaginary reference lines extending across the wound.

To distinguish them, he said he designates a 12 o’clock position at the top of the field, makes a double nick, and inks it blue, since that’s the color of the sky.

At the 6 o’clock position, he makes a single nick and marks it green, for the earth.

A third and fourth color can be designated for the 3 and 9 o’clock positions for further clarity, suggested Dr. Steinman, director of dermatologic and skin cancer surgery at Scott and White Healthcare in Temple, Tex.

Some surgeons mark the center yellow.

One day, when you least expect it, "your specimen will end up on the floor," he predicted. "This will happen to you ... [and you’ll say], thank God for the double nick."

With the ink as a guide, it will become clear to you, a technician, or a pathologist which way is up on the specimen, he said at the meeting sponsored by the American Society for Mohs Surgery.

When using green ink, remember that it’s a vital dye and can stain counters and other surfaces, noted Dr. Steinman.

"Mark before excising the specimen, because the specimen is going to rotate and contract," he said.

Dr. Steinman said he also color codes important histologic features on the Mohs map, which functions as a pathology report, medical record, and medicolegal document.

"Mark the tumor in red and everything else in black," specifically labeling all nontumor findings such as dense inflammation, incomplete margins, scars, or unrelated tumors.

Dr. Edward Yob, a dermatologic surgeon in private practice in Tulsa, Okla., said he color codes his slides as well.

"If it’s the fourth stage, it’s going to be pink," he said. Consistency is key.

Dr. Steinman said the Mohs map, with its legend and color coding, will serve as an essential document for later reference.

"Without the human, without the slides, 15 or 16 years later I can tell you exactly what I did and why," he said.

Dr. Steinman and Dr. Yob said they had no relevant financial disclosures.

SAN DIEGO – Color coding reference marks on a specimen and a Mohs map preserves orientation, no matter what happens on the way to the microscope, according to Dr. Howard Steinman.

Reference marks, he explained, are small nicks made with a scalpel, sutures, or staples that serve as extensions of imaginary reference lines extending across the wound.

To distinguish them, he said he designates a 12 o’clock position at the top of the field, makes a double nick, and inks it blue, since that’s the color of the sky.

At the 6 o’clock position, he makes a single nick and marks it green, for the earth.

A third and fourth color can be designated for the 3 and 9 o’clock positions for further clarity, suggested Dr. Steinman, director of dermatologic and skin cancer surgery at Scott and White Healthcare in Temple, Tex.

Some surgeons mark the center yellow.

One day, when you least expect it, "your specimen will end up on the floor," he predicted. "This will happen to you ... [and you’ll say], thank God for the double nick."

With the ink as a guide, it will become clear to you, a technician, or a pathologist which way is up on the specimen, he said at the meeting sponsored by the American Society for Mohs Surgery.

When using green ink, remember that it’s a vital dye and can stain counters and other surfaces, noted Dr. Steinman.

"Mark before excising the specimen, because the specimen is going to rotate and contract," he said.

Dr. Steinman said he also color codes important histologic features on the Mohs map, which functions as a pathology report, medical record, and medicolegal document.

"Mark the tumor in red and everything else in black," specifically labeling all nontumor findings such as dense inflammation, incomplete margins, scars, or unrelated tumors.

Dr. Edward Yob, a dermatologic surgeon in private practice in Tulsa, Okla., said he color codes his slides as well.

"If it’s the fourth stage, it’s going to be pink," he said. Consistency is key.

Dr. Steinman said the Mohs map, with its legend and color coding, will serve as an essential document for later reference.

"Without the human, without the slides, 15 or 16 years later I can tell you exactly what I did and why," he said.

Dr. Steinman and Dr. Yob said they had no relevant financial disclosures.

SAN DIEGO – Color coding reference marks on a specimen and a Mohs map preserves orientation, no matter what happens on the way to the microscope, according to Dr. Howard Steinman.

Reference marks, he explained, are small nicks made with a scalpel, sutures, or staples that serve as extensions of imaginary reference lines extending across the wound.

To distinguish them, he said he designates a 12 o’clock position at the top of the field, makes a double nick, and inks it blue, since that’s the color of the sky.

At the 6 o’clock position, he makes a single nick and marks it green, for the earth.

A third and fourth color can be designated for the 3 and 9 o’clock positions for further clarity, suggested Dr. Steinman, director of dermatologic and skin cancer surgery at Scott and White Healthcare in Temple, Tex.

Some surgeons mark the center yellow.

One day, when you least expect it, "your specimen will end up on the floor," he predicted. "This will happen to you ... [and you’ll say], thank God for the double nick."

With the ink as a guide, it will become clear to you, a technician, or a pathologist which way is up on the specimen, he said at the meeting sponsored by the American Society for Mohs Surgery.

When using green ink, remember that it’s a vital dye and can stain counters and other surfaces, noted Dr. Steinman.

"Mark before excising the specimen, because the specimen is going to rotate and contract," he said.

Dr. Steinman said he also color codes important histologic features on the Mohs map, which functions as a pathology report, medical record, and medicolegal document.

"Mark the tumor in red and everything else in black," specifically labeling all nontumor findings such as dense inflammation, incomplete margins, scars, or unrelated tumors.

Dr. Edward Yob, a dermatologic surgeon in private practice in Tulsa, Okla., said he color codes his slides as well.

"If it’s the fourth stage, it’s going to be pink," he said. Consistency is key.

Dr. Steinman said the Mohs map, with its legend and color coding, will serve as an essential document for later reference.

"Without the human, without the slides, 15 or 16 years later I can tell you exactly what I did and why," he said.

Dr. Steinman and Dr. Yob said they had no relevant financial disclosures.

SAN DIEGO – Sewing supplies, tricks of the dental trade, and a nice firm handshake are handy, value-added elements of a smooth-running Mohs surgery practice, speakers said at the meeting sponsored by the American Society for Mohs Surgery.

Many of the pearls offered during 3 days of clinical sessions are cheap, simple, and easy to employ, making life just a bit easier during complex Mohs surgical procedures or in a busy office setting.

Among the suggestions:

• Take a trip to the fabric store. A $10 sewing magnet, sterilized in your office, can grab a needle off a tray or the floor. Buttons can be used as bolsters to distribute tension on a wound, stabilize a graft, or form a scaffold for healing of the helical sulcus following repair, said Dr. Edward H. Yob, a dermatologic surgeon in private practice in Tulsa, Okla.

• Put a fine point on it. Tired of smudged labels on your slides? Order some extra fine permanent markers (offered by Pilot with the code SCA-UF), which can be used on glass, said Dr. Howard Steinman, director of dermatologic and skin cancer surgery at Scott and White HealthCare in Temple, Tex.

• Brush up on your inking technique. Dr. Steinman said he has become a recent convert to small, tissue-marking dye systems by Cancer Diagnostics. These kits come with dyes in seven colors, each with a small brush for precise distribution. The bottles "tend to wobble a little bit" in the case, so Dr. Steinman said he lines the base of the kit with double-sided tape to hold them steady. "They’re certainly more convenient than the wooden sticks," he said.

• Peruse a dental supply catalog. Dr. Yob apparently forgoes the Lands’ End catalog in favor of a veritable shopping spree through pages of products such as LolliCaine topical anesthetic gel (to numb intraoral tissue prior to a needle prick); dental rolls, 2,000 to a box (to shield sharp instruments, pack a nose, or serve as bolsters or pressure points under dressings); and dental syringes and needles.

• Invest in a thermal cautery device. If you’re in a region where you treat a fair number of elderly patients with implanted defibrillators, you’re likely to appreciate having an alternative to an electrocautery unit. "You really don’t want to set them off while you’re doing a procedure," said Dr. Yob.

• Grip and grin. Dr. Yob said he always shakes the hand of a patient following a biopsy or Mohs procedure, not only because it’s a good business practice, but also because he can check for clammy hands or a weak grip. "If that hand is clammy, I’m going to be concerned about that patient getting up quickly," he said.

• Pass the salts. If a patient feels weak, nauseous, or woozy, Dr. Yob, a nurse, or office assistant can grab ammonia salts taped to every paper towel dispenser in the office for a quick antidote.

• Put hair in its place. While Vaseline petroleum jelly is cheap and convenient, patients will appreciate it if you have on hand hair clips, bands, and Dippity-do hair gel, instead of glopping up their hair to clear a surgical field on the scalp, said Dr. Carlos Garcia, director of dermatologic surgery and cutaneous oncology at the University of Oklahoma, Oklahoma City.

• Go one step cheaper than generic. If you love the flexibility and self-adherent qualities of 3M’s Coban wrap, you’ve probably discovered the less-expensive alternative, Co-Flex by Andover Healthcare. But perhaps you haven’t stopped by a feed store lately to discover Vetrap bandaging tape, also by 3M, which is far more affordable than the suspiciously similar human product, said Dr. Yob.

• Introduce yourself to the ENT resident’s friend. While working on a complex Mohs case on a patient’s neck, Dr. Steinman said he learned an important anatomy lesson from his third-year resident, who happens to be a board-certified otolaryngologist. The resident pointed out that Dr. Steinman was in safe territory as long as he stayed above the posterior belly of the digastric muscle, known in ENT circles as "the resident’s friend."

None of the speakers who offered clinical pearls reported having financial disclosures associated with the products they recommended.

SAN DIEGO – Sewing supplies, tricks of the dental trade, and a nice firm handshake are handy, value-added elements of a smooth-running Mohs surgery practice, speakers said at the meeting sponsored by the American Society for Mohs Surgery.

Many of the pearls offered during 3 days of clinical sessions are cheap, simple, and easy to employ, making life just a bit easier during complex Mohs surgical procedures or in a busy office setting.

Among the suggestions:

• Take a trip to the fabric store. A $10 sewing magnet, sterilized in your office, can grab a needle off a tray or the floor. Buttons can be used as bolsters to distribute tension on a wound, stabilize a graft, or form a scaffold for healing of the helical sulcus following repair, said Dr. Edward H. Yob, a dermatologic surgeon in private practice in Tulsa, Okla.

• Put a fine point on it. Tired of smudged labels on your slides? Order some extra fine permanent markers (offered by Pilot with the code SCA-UF), which can be used on glass, said Dr. Howard Steinman, director of dermatologic and skin cancer surgery at Scott and White HealthCare in Temple, Tex.

• Brush up on your inking technique. Dr. Steinman said he has become a recent convert to small, tissue-marking dye systems by Cancer Diagnostics. These kits come with dyes in seven colors, each with a small brush for precise distribution. The bottles "tend to wobble a little bit" in the case, so Dr. Steinman said he lines the base of the kit with double-sided tape to hold them steady. "They’re certainly more convenient than the wooden sticks," he said.

• Peruse a dental supply catalog. Dr. Yob apparently forgoes the Lands’ End catalog in favor of a veritable shopping spree through pages of products such as LolliCaine topical anesthetic gel (to numb intraoral tissue prior to a needle prick); dental rolls, 2,000 to a box (to shield sharp instruments, pack a nose, or serve as bolsters or pressure points under dressings); and dental syringes and needles.

• Invest in a thermal cautery device. If you’re in a region where you treat a fair number of elderly patients with implanted defibrillators, you’re likely to appreciate having an alternative to an electrocautery unit. "You really don’t want to set them off while you’re doing a procedure," said Dr. Yob.

• Grip and grin. Dr. Yob said he always shakes the hand of a patient following a biopsy or Mohs procedure, not only because it’s a good business practice, but also because he can check for clammy hands or a weak grip. "If that hand is clammy, I’m going to be concerned about that patient getting up quickly," he said.

• Pass the salts. If a patient feels weak, nauseous, or woozy, Dr. Yob, a nurse, or office assistant can grab ammonia salts taped to every paper towel dispenser in the office for a quick antidote.

• Put hair in its place. While Vaseline petroleum jelly is cheap and convenient, patients will appreciate it if you have on hand hair clips, bands, and Dippity-do hair gel, instead of glopping up their hair to clear a surgical field on the scalp, said Dr. Carlos Garcia, director of dermatologic surgery and cutaneous oncology at the University of Oklahoma, Oklahoma City.

• Go one step cheaper than generic. If you love the flexibility and self-adherent qualities of 3M’s Coban wrap, you’ve probably discovered the less-expensive alternative, Co-Flex by Andover Healthcare. But perhaps you haven’t stopped by a feed store lately to discover Vetrap bandaging tape, also by 3M, which is far more affordable than the suspiciously similar human product, said Dr. Yob.

• Introduce yourself to the ENT resident’s friend. While working on a complex Mohs case on a patient’s neck, Dr. Steinman said he learned an important anatomy lesson from his third-year resident, who happens to be a board-certified otolaryngologist. The resident pointed out that Dr. Steinman was in safe territory as long as he stayed above the posterior belly of the digastric muscle, known in ENT circles as "the resident’s friend."

None of the speakers who offered clinical pearls reported having financial disclosures associated with the products they recommended.

SAN DIEGO – Sewing supplies, tricks of the dental trade, and a nice firm handshake are handy, value-added elements of a smooth-running Mohs surgery practice, speakers said at the meeting sponsored by the American Society for Mohs Surgery.

Many of the pearls offered during 3 days of clinical sessions are cheap, simple, and easy to employ, making life just a bit easier during complex Mohs surgical procedures or in a busy office setting.

Among the suggestions:

• Take a trip to the fabric store. A $10 sewing magnet, sterilized in your office, can grab a needle off a tray or the floor. Buttons can be used as bolsters to distribute tension on a wound, stabilize a graft, or form a scaffold for healing of the helical sulcus following repair, said Dr. Edward H. Yob, a dermatologic surgeon in private practice in Tulsa, Okla.

• Put a fine point on it. Tired of smudged labels on your slides? Order some extra fine permanent markers (offered by Pilot with the code SCA-UF), which can be used on glass, said Dr. Howard Steinman, director of dermatologic and skin cancer surgery at Scott and White HealthCare in Temple, Tex.

• Brush up on your inking technique. Dr. Steinman said he has become a recent convert to small, tissue-marking dye systems by Cancer Diagnostics. These kits come with dyes in seven colors, each with a small brush for precise distribution. The bottles "tend to wobble a little bit" in the case, so Dr. Steinman said he lines the base of the kit with double-sided tape to hold them steady. "They’re certainly more convenient than the wooden sticks," he said.

• Peruse a dental supply catalog. Dr. Yob apparently forgoes the Lands’ End catalog in favor of a veritable shopping spree through pages of products such as LolliCaine topical anesthetic gel (to numb intraoral tissue prior to a needle prick); dental rolls, 2,000 to a box (to shield sharp instruments, pack a nose, or serve as bolsters or pressure points under dressings); and dental syringes and needles.

• Invest in a thermal cautery device. If you’re in a region where you treat a fair number of elderly patients with implanted defibrillators, you’re likely to appreciate having an alternative to an electrocautery unit. "You really don’t want to set them off while you’re doing a procedure," said Dr. Yob.

• Grip and grin. Dr. Yob said he always shakes the hand of a patient following a biopsy or Mohs procedure, not only because it’s a good business practice, but also because he can check for clammy hands or a weak grip. "If that hand is clammy, I’m going to be concerned about that patient getting up quickly," he said.

• Pass the salts. If a patient feels weak, nauseous, or woozy, Dr. Yob, a nurse, or office assistant can grab ammonia salts taped to every paper towel dispenser in the office for a quick antidote.

• Put hair in its place. While Vaseline petroleum jelly is cheap and convenient, patients will appreciate it if you have on hand hair clips, bands, and Dippity-do hair gel, instead of glopping up their hair to clear a surgical field on the scalp, said Dr. Carlos Garcia, director of dermatologic surgery and cutaneous oncology at the University of Oklahoma, Oklahoma City.

• Go one step cheaper than generic. If you love the flexibility and self-adherent qualities of 3M’s Coban wrap, you’ve probably discovered the less-expensive alternative, Co-Flex by Andover Healthcare. But perhaps you haven’t stopped by a feed store lately to discover Vetrap bandaging tape, also by 3M, which is far more affordable than the suspiciously similar human product, said Dr. Yob.

• Introduce yourself to the ENT resident’s friend. While working on a complex Mohs case on a patient’s neck, Dr. Steinman said he learned an important anatomy lesson from his third-year resident, who happens to be a board-certified otolaryngologist. The resident pointed out that Dr. Steinman was in safe territory as long as he stayed above the posterior belly of the digastric muscle, known in ENT circles as "the resident’s friend."

None of the speakers who offered clinical pearls reported having financial disclosures associated with the products they recommended.

LAS VEGAS – A large array of home laser and light devices can be purchased on the Internet, with sellers touting their cosmetic benefits in treating acne, age spots, large pores, wrinkles, sagging skin, puffy eyes, rosacea, cold sores, and many other skin conditions.

However, few of the devices have been studied or approved by the Food and Drug Administration, and "some of them sound sort of scary," said Dr. Anne M. Chapas. "There are a lot of junk devices that, at the very least, are a waste of money and, at worst, could be harmful to consumers."

Sales of home cosmetic devices totaled $500 million last year, and are expected to nearly double to $950 million in 2015, according to Dr. Chapas.

"At this time, it’s a buyer-beware market," she said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "As dermatologists, we really need to jump on this" and educate patients and consumers about what the best devices really are.

Extensive Internet listings include devices using blue, yellow, and red light laser ultrasonic therapy. "I know that if I’m confused about it, my patients are certainly going to have a lot of questions," said Dr. Chapas of the department of dermatology at New York University.

Some home devices may serve a purpose for maintenance therapy between office treatments, a strategy that Dr. Chapas employs for some patients with acne. A helpful home device also can generate a patient’s interest in getting office-based laser treatments.

These new home devices tend to fall into four categories, she said: Diode or intense pulsed light devices that target hair removal, light-emitting diode (LED) or heat devices that claim benefits for acne treatment, devices to treat wrinkles using infrared light, and a home phototherapy device that provides UVB.

Hair Removal

Professionals use a variety of laser devices for hair removal – Dr. Chapas said she prefers the long-pulsed alexandrite or long-pulsed Nd:YAG lasers – while home devices tend to use diode, intense pulsed light, or heat technology.

Home devices use lower fluences and longer pulse widths, compared with office-based treatments. To be effective, energy must be absorbed by the hair shaft, penetrate deep enough to affect the follicle, and be administered in a pulse duration that is less than the thermal relaxation time of the hair follicle.

One of the first home laser devices to be studied, the Tria diode laser, showed mean hair reductions of 60% at 1 month, 41% at 6 months, and 33% at 12 months after three home treatments in 77 appropriate users (Lasers Surg. Med. 2007;39:476-93). A skin color sensor blocks the device on darker skin colors that could easily blister. The FDA approved the device for off-face use; it costs approximately $395.

The Silk’n SensEpil by Sephora uses intense pulsed light at low energy and short pulse durations. Approved for use on skin on or below the cheeks, it costs approximately $499 plus the price of disposable parts. Three studies in 34, 20, and 10 females, respectively, found it works best for thin hair on the legs and arms, and is less effective for hair on the axilla or inguinal areas, Dr. Chapas said (J. Cosmet. Laser Ther. 2009;11:106-9; Dermatol. Surg. 2009;35:483-9; and Lasers Surg. Med. 2010;42:287-91).

The No! No! device uses patented Thermicon technology employing a thermal filament to deliver heat to the hair shaft. In a study of 12 patients, twice-weekly treatment for 6 weeks with the low-energy device removed 44% of hair on the legs and 15% of hair in the bikini area at the 12-week follow-up (J. Drugs Dermatol. 2007;6:788-92).

"I think you would have to spend a lot of your time" to get results even on the legs, Dr. Chapas said. The No! No! costs approximately $270.

Acne

Home devices tend to use LED, intense pulsed light, and heat technology. Eight studies since 1999 have shown that office treatments with blue light are effective in eliminating Propionibacterium acnes bacteria, and four home devices now offer self-application of blue light, she noted.

In her office treatments, Dr. Chapas said she usually treats patients for 11-20 minutes twice a week for 4-8 weeks. "For a lot of patients, it’s just a pain to come into the office twice a week for 8 weeks, so there really is a need for a home device," she said. "I think these devices can help, and I now use them in between my PDT [photodynamic therapy] treatments."

The power density of the various devices makes a difference. Lower power density requires twice-weekly, 20-minute applications on each side of the face, which can be difficult for patients to do. Higher-density blue light devices, such as the Tria skin clarifying system, require less than 3 minutes twice a day, she said.

A company-sponsored study of the Tria device in 33 adults showed significant reductions in inflammatory acne lesions after 3 weeks of treatments (J. Drugs Dermatol. 2011;6:596-602).

"Just clearing P. acnes isn’t enough a lot of time because the antigens are still there," Dr. Chapas said. The Tria system comes with washes and topical creams, or patients can use the device with whatever prescription regimen they are on.

Several devices use heat shock proteins to reduce P. acnes, but these too are not enough when used alone because they do not reduce inflammation or comedones. "They do seem to work, but you have to do it frequently and you have to put it on every single acne spot," she said. Heat devices by ThermaClear, Zeno, and No! No! cost approximately $149-$180.

The Claro home device by Sephora combines heat and blue and red light to clear P. acnes and costs approximately $195.

Rejuvenation

The PaloVia fractionated laser (Palomar Medical Technologies) is approved for home treatment of periorbital rhytids. A blinded study of 34 subjects presented at the 2010 meeting of the American Society for Laser Medicine and Surgery reported a 1-point improvement on the 9-point Fitzpatrick wrinkle scale in 90% of patients after 4 weeks of daily use and in 79% after 4 weeks of twice-weekly maintenance treatments, Dr. Chapas said.

Phototherapy

The Levia UVB device (Lerner Medical Devices) is approved for home use to treat psoriasis, vitiligo, and atopic dermatitis. Dr. Chapas said she likes to prescribe it for children with vitiligo who have to travel a significant distance to her office and find it difficult to get time off from school for in-office excimer laser treatments.

"It’s something you can write a prescription for and you can program" to the desired settings, she said. Multiple studies have shown that home UVB therapy is as effective as office treatments.

Dr. Chapas said she has been a consultant for Tria, Phillips, and Solta.

LAS VEGAS – A large array of home laser and light devices can be purchased on the Internet, with sellers touting their cosmetic benefits in treating acne, age spots, large pores, wrinkles, sagging skin, puffy eyes, rosacea, cold sores, and many other skin conditions.

However, few of the devices have been studied or approved by the Food and Drug Administration, and "some of them sound sort of scary," said Dr. Anne M. Chapas. "There are a lot of junk devices that, at the very least, are a waste of money and, at worst, could be harmful to consumers."

Sales of home cosmetic devices totaled $500 million last year, and are expected to nearly double to $950 million in 2015, according to Dr. Chapas.

"At this time, it’s a buyer-beware market," she said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "As dermatologists, we really need to jump on this" and educate patients and consumers about what the best devices really are.

Extensive Internet listings include devices using blue, yellow, and red light laser ultrasonic therapy. "I know that if I’m confused about it, my patients are certainly going to have a lot of questions," said Dr. Chapas of the department of dermatology at New York University.

Some home devices may serve a purpose for maintenance therapy between office treatments, a strategy that Dr. Chapas employs for some patients with acne. A helpful home device also can generate a patient’s interest in getting office-based laser treatments.

These new home devices tend to fall into four categories, she said: Diode or intense pulsed light devices that target hair removal, light-emitting diode (LED) or heat devices that claim benefits for acne treatment, devices to treat wrinkles using infrared light, and a home phototherapy device that provides UVB.

Hair Removal

Professionals use a variety of laser devices for hair removal – Dr. Chapas said she prefers the long-pulsed alexandrite or long-pulsed Nd:YAG lasers – while home devices tend to use diode, intense pulsed light, or heat technology.

Home devices use lower fluences and longer pulse widths, compared with office-based treatments. To be effective, energy must be absorbed by the hair shaft, penetrate deep enough to affect the follicle, and be administered in a pulse duration that is less than the thermal relaxation time of the hair follicle.

One of the first home laser devices to be studied, the Tria diode laser, showed mean hair reductions of 60% at 1 month, 41% at 6 months, and 33% at 12 months after three home treatments in 77 appropriate users (Lasers Surg. Med. 2007;39:476-93). A skin color sensor blocks the device on darker skin colors that could easily blister. The FDA approved the device for off-face use; it costs approximately $395.

The Silk’n SensEpil by Sephora uses intense pulsed light at low energy and short pulse durations. Approved for use on skin on or below the cheeks, it costs approximately $499 plus the price of disposable parts. Three studies in 34, 20, and 10 females, respectively, found it works best for thin hair on the legs and arms, and is less effective for hair on the axilla or inguinal areas, Dr. Chapas said (J. Cosmet. Laser Ther. 2009;11:106-9; Dermatol. Surg. 2009;35:483-9; and Lasers Surg. Med. 2010;42:287-91).

The No! No! device uses patented Thermicon technology employing a thermal filament to deliver heat to the hair shaft. In a study of 12 patients, twice-weekly treatment for 6 weeks with the low-energy device removed 44% of hair on the legs and 15% of hair in the bikini area at the 12-week follow-up (J. Drugs Dermatol. 2007;6:788-92).

"I think you would have to spend a lot of your time" to get results even on the legs, Dr. Chapas said. The No! No! costs approximately $270.

Acne

Home devices tend to use LED, intense pulsed light, and heat technology. Eight studies since 1999 have shown that office treatments with blue light are effective in eliminating Propionibacterium acnes bacteria, and four home devices now offer self-application of blue light, she noted.

In her office treatments, Dr. Chapas said she usually treats patients for 11-20 minutes twice a week for 4-8 weeks. "For a lot of patients, it’s just a pain to come into the office twice a week for 8 weeks, so there really is a need for a home device," she said. "I think these devices can help, and I now use them in between my PDT [photodynamic therapy] treatments."

The power density of the various devices makes a difference. Lower power density requires twice-weekly, 20-minute applications on each side of the face, which can be difficult for patients to do. Higher-density blue light devices, such as the Tria skin clarifying system, require less than 3 minutes twice a day, she said.

A company-sponsored study of the Tria device in 33 adults showed significant reductions in inflammatory acne lesions after 3 weeks of treatments (J. Drugs Dermatol. 2011;6:596-602).

"Just clearing P. acnes isn’t enough a lot of time because the antigens are still there," Dr. Chapas said. The Tria system comes with washes and topical creams, or patients can use the device with whatever prescription regimen they are on.

Several devices use heat shock proteins to reduce P. acnes, but these too are not enough when used alone because they do not reduce inflammation or comedones. "They do seem to work, but you have to do it frequently and you have to put it on every single acne spot," she said. Heat devices by ThermaClear, Zeno, and No! No! cost approximately $149-$180.

The Claro home device by Sephora combines heat and blue and red light to clear P. acnes and costs approximately $195.

Rejuvenation

The PaloVia fractionated laser (Palomar Medical Technologies) is approved for home treatment of periorbital rhytids. A blinded study of 34 subjects presented at the 2010 meeting of the American Society for Laser Medicine and Surgery reported a 1-point improvement on the 9-point Fitzpatrick wrinkle scale in 90% of patients after 4 weeks of daily use and in 79% after 4 weeks of twice-weekly maintenance treatments, Dr. Chapas said.

Phototherapy

The Levia UVB device (Lerner Medical Devices) is approved for home use to treat psoriasis, vitiligo, and atopic dermatitis. Dr. Chapas said she likes to prescribe it for children with vitiligo who have to travel a significant distance to her office and find it difficult to get time off from school for in-office excimer laser treatments.

"It’s something you can write a prescription for and you can program" to the desired settings, she said. Multiple studies have shown that home UVB therapy is as effective as office treatments.

Dr. Chapas said she has been a consultant for Tria, Phillips, and Solta.

LAS VEGAS – A large array of home laser and light devices can be purchased on the Internet, with sellers touting their cosmetic benefits in treating acne, age spots, large pores, wrinkles, sagging skin, puffy eyes, rosacea, cold sores, and many other skin conditions.

However, few of the devices have been studied or approved by the Food and Drug Administration, and "some of them sound sort of scary," said Dr. Anne M. Chapas. "There are a lot of junk devices that, at the very least, are a waste of money and, at worst, could be harmful to consumers."

Sales of home cosmetic devices totaled $500 million last year, and are expected to nearly double to $950 million in 2015, according to Dr. Chapas.

"At this time, it’s a buyer-beware market," she said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "As dermatologists, we really need to jump on this" and educate patients and consumers about what the best devices really are.

Extensive Internet listings include devices using blue, yellow, and red light laser ultrasonic therapy. "I know that if I’m confused about it, my patients are certainly going to have a lot of questions," said Dr. Chapas of the department of dermatology at New York University.

Some home devices may serve a purpose for maintenance therapy between office treatments, a strategy that Dr. Chapas employs for some patients with acne. A helpful home device also can generate a patient’s interest in getting office-based laser treatments.

These new home devices tend to fall into four categories, she said: Diode or intense pulsed light devices that target hair removal, light-emitting diode (LED) or heat devices that claim benefits for acne treatment, devices to treat wrinkles using infrared light, and a home phototherapy device that provides UVB.

Hair Removal

Professionals use a variety of laser devices for hair removal – Dr. Chapas said she prefers the long-pulsed alexandrite or long-pulsed Nd:YAG lasers – while home devices tend to use diode, intense pulsed light, or heat technology.

Home devices use lower fluences and longer pulse widths, compared with office-based treatments. To be effective, energy must be absorbed by the hair shaft, penetrate deep enough to affect the follicle, and be administered in a pulse duration that is less than the thermal relaxation time of the hair follicle.

One of the first home laser devices to be studied, the Tria diode laser, showed mean hair reductions of 60% at 1 month, 41% at 6 months, and 33% at 12 months after three home treatments in 77 appropriate users (Lasers Surg. Med. 2007;39:476-93). A skin color sensor blocks the device on darker skin colors that could easily blister. The FDA approved the device for off-face use; it costs approximately $395.

The Silk’n SensEpil by Sephora uses intense pulsed light at low energy and short pulse durations. Approved for use on skin on or below the cheeks, it costs approximately $499 plus the price of disposable parts. Three studies in 34, 20, and 10 females, respectively, found it works best for thin hair on the legs and arms, and is less effective for hair on the axilla or inguinal areas, Dr. Chapas said (J. Cosmet. Laser Ther. 2009;11:106-9; Dermatol. Surg. 2009;35:483-9; and Lasers Surg. Med. 2010;42:287-91).

The No! No! device uses patented Thermicon technology employing a thermal filament to deliver heat to the hair shaft. In a study of 12 patients, twice-weekly treatment for 6 weeks with the low-energy device removed 44% of hair on the legs and 15% of hair in the bikini area at the 12-week follow-up (J. Drugs Dermatol. 2007;6:788-92).

"I think you would have to spend a lot of your time" to get results even on the legs, Dr. Chapas said. The No! No! costs approximately $270.

Acne

Home devices tend to use LED, intense pulsed light, and heat technology. Eight studies since 1999 have shown that office treatments with blue light are effective in eliminating Propionibacterium acnes bacteria, and four home devices now offer self-application of blue light, she noted.

In her office treatments, Dr. Chapas said she usually treats patients for 11-20 minutes twice a week for 4-8 weeks. "For a lot of patients, it’s just a pain to come into the office twice a week for 8 weeks, so there really is a need for a home device," she said. "I think these devices can help, and I now use them in between my PDT [photodynamic therapy] treatments."

The power density of the various devices makes a difference. Lower power density requires twice-weekly, 20-minute applications on each side of the face, which can be difficult for patients to do. Higher-density blue light devices, such as the Tria skin clarifying system, require less than 3 minutes twice a day, she said.

A company-sponsored study of the Tria device in 33 adults showed significant reductions in inflammatory acne lesions after 3 weeks of treatments (J. Drugs Dermatol. 2011;6:596-602).

"Just clearing P. acnes isn’t enough a lot of time because the antigens are still there," Dr. Chapas said. The Tria system comes with washes and topical creams, or patients can use the device with whatever prescription regimen they are on.

Several devices use heat shock proteins to reduce P. acnes, but these too are not enough when used alone because they do not reduce inflammation or comedones. "They do seem to work, but you have to do it frequently and you have to put it on every single acne spot," she said. Heat devices by ThermaClear, Zeno, and No! No! cost approximately $149-$180.

The Claro home device by Sephora combines heat and blue and red light to clear P. acnes and costs approximately $195.

Rejuvenation

The PaloVia fractionated laser (Palomar Medical Technologies) is approved for home treatment of periorbital rhytids. A blinded study of 34 subjects presented at the 2010 meeting of the American Society for Laser Medicine and Surgery reported a 1-point improvement on the 9-point Fitzpatrick wrinkle scale in 90% of patients after 4 weeks of daily use and in 79% after 4 weeks of twice-weekly maintenance treatments, Dr. Chapas said.

Phototherapy

The Levia UVB device (Lerner Medical Devices) is approved for home use to treat psoriasis, vitiligo, and atopic dermatitis. Dr. Chapas said she likes to prescribe it for children with vitiligo who have to travel a significant distance to her office and find it difficult to get time off from school for in-office excimer laser treatments.

"It’s something you can write a prescription for and you can program" to the desired settings, she said. Multiple studies have shown that home UVB therapy is as effective as office treatments.

Dr. Chapas said she has been a consultant for Tria, Phillips, and Solta.

Because of the seemingly endless array of topics to cover in this column, I have never directly revisited a subject here (although some botanical ingredients have received individual attention as well as some focus as members of a class of compounds). But much has changed since I last covered phosphatidylcholine in 2003. In this month’s column, I will review recent research and discuss new safety concerns regarding the use of phosphatidylcholine in mesotherapy.

Emerging about 50 years ago and popular in Europe and South America (J. Cosmet. Laser Ther. 2005;7:17-9), mesotherapy entails the subcutaneous injection of pharmaceutical, homeopathic, botanical, vitamin, or other agents with the intention of initiating localized lipolysis in cellulite or other areas with undesired fat deposits. While this is considered a noninvasive alternative to liposuction or lipectomy, the use of phosphatidylcholine for this purpose has not been approved by the U.S. Food and Drug Administration.

Off-Label Use of Phosphatidylcholine Products 

The practice of using a formulation containing soybean-derived phosphatidylcholine in mesotherapy (also called lipo-dissolve, lipotherapy, or injection lipolysis) became popular in the mid-1990s in Brazil. The substance, known as Lipostabil, is a drug that was first used to reduce triglyceride and cholesterol levels in patients with coronary artery disease. However, lipo-dissolve products are marketed in the United States as natural compounds, even though the FDA considers such substances drugs and has not approved of their use for fat removal (http://www.npr.org/templates/story/story.php?storyId=11487499). Off-label use has become increasingly common in Europe and the United States. Given a spate of complications seen after the use of Lipostabil in Brazil, ANVISA, the Brazilian equivalent of the FDA, banned the phosphatidylcholine-containing product. This should give us all pause, since it is very rare for Brazil to ban medical drugs or devices.

Phosphatidylcholine, a component of lipoproteins, is a purified extract from lecithin. It was originally used in the medical setting for emergencies and treating atheroma plaques in cardiac disease (J. Drugs Dermatol. 2003;2:511-8). This phospholipid is a major component of all cell membranes and is the primary phospholipid in plasma. Composed of choline, phosphoric acid, and fatty acids, the phosphatidylcholine molecule occurs naturally in humans (especially in nerve tissue, the liver, and semen), and is obtained through consumption of soybeans, egg yolks, meat, and, rarely, vegetables. The consumption or injection of phosphatidylcholine is believed to augment phosphatidylcholine in lipoproteins, thereby enhancing their ability to mobilize fat and cholesterol. Further, phosphatidylcholine has been demonstrated to lower systemic levels of cholesterol and triglycerides and is believed to induce lipolysis (Dermatol. Surg. 2001;27:391-2).

 Promising Findings for Use in Lipolysis

In the first paper that sparked the craze around this procedure, Rittes reported on the technique that she had begun using in 1995, with fellow Brazilian doctors. The procedure was introduced at the Dermatologic Brazilian Congress in 1999, and published in 2001 as a treatment of lower eyelid bulging caused by prominent fat pads (Dermatol. Surg. 2001;27:391-2). In the 2001 study, which featured subjective assessments of improvement and was not placebo controlled, Rittes concluded that phosphatidylcholine injections (250 mg/5 mL) into periorbital fat pads could postpone the need for or possibly substitute for lower eyelid blepharoplasty. (These findings on the use of phosphatidylcholine for correction of infraorbital fat pads were recently duplicated in an open-label study of 21 subjects conducted by Treacy and Goldberg [J. Cosmet. Laser Ther. 2006;8:129-32]).

In a 2003 study, Rittes continued to suggest that this in-office procedure was a suitable alternative to surgery, in this case lipectomy or liposuction. Specifically, 50 patients received injections of phosphatidylcholine (250 mg/5 mL) into fat deposits in the abdomen, neck, arms, or thighs in an 80-cm² area using a 30G 1/2-inch insulin needle. Rittes observed clear improvement in all patients, with a significant decline in fat deposits and no recurrence or weight gain over a 2-year follow-up (Aesthetic Plast. Surg. 2003;27:315-8).

The next year, Hexsel et al. reported on their clinical experience using 250-mg/mL phosphatidylcholine injections to treat subcutaneous fat deposits in volunteers whose injections, in various localized fat deposits, were separated by a minimum interval of 1 week and mean interval of 15 days. They found that phosphatidylcholine was efficacious in diminishing the treated fatty areas, and was accompanied by minimal side effects. The investigators concluded that this noninvasive, off-label use of phosphatidylcholine was safe, effective, and inexpensive (J. Drugs Dermatol. 2003;2:511-8).

In 2004, Rotunda et al. assessed the mechanism of action and characteristics of the active components of a clinically used, injectable fat-dissolution formulation containing phosphatidylcholine and sodium deoxycholate, a bile salt incorporated to solubilize in water the natural phospholipid. In this experiment, the investigators performed cell viability and cell membrane lysis assays on cell cultures and porcine skin after treatment with the phosphatidylcholine product, isolated sodium deoxycholate, or common laboratory detergents. In comparing the results with phosphatidylcholine and isolated sodium deoxycholate, they found a significant and comparable loss of cell viability, cell membrane lysis, and disruption of fat and musculature in cell cultures and tissue specimens. The effects generated from the laboratory detergents were similar. The investigators concluded that the popular fat-dissolution formula based on phosphatidylcholine works mainly as a detergent, inducing nonspecific cell membrane lysis. Notably, they also suggested that sodium deoxycholate was the major active constituent causing the cell lysis, and urged caution for physicians regarding this procedure pending the availability of sufficient safety data (Dermatol. Surg. 2004;30:1001-8).

In 2005, Rose and Morgan took skin biopsies, 1 and 2 weeks after mesotherapy, from a patient who had undergone the procedure with phosphatidylcholine and deoxycholate. Both biopsies revealed normal epithelium and dermis, with a mixed septal and lobular panniculitis. The investigators noted that the fat lobules were infiltrated by an elevated number of lymphocytes and macrophages, the latter of which consisted of conventional forms, foam cells, and multinucleated fat-containing giant cells. Serous atrophy and microcyst development was linked to inflammation. In this first histologic study to illustrate the mechanism of action of phosphatidylcholine and deoxycholate, the authors concluded that mesotherapy with these compounds clearly impacted subcutaneous fat. They speculated that inflammatory-mediated necrosis and resorption likely accounted for the decrease in subcutaneous fat (J. Cosmet. Laser Ther. 2005;7:17-9).

In 2007, Sasaki et al. conducted a study in nine healthy female volunteers with grade II-III thigh cellulite to determine the safety and efficacy of a phosphatidylcholine-based cosmeceutical anticellulite gel combined with light-emitting diode (LED) treatment at 660 nm (red) and 950 nm (near-infrared). In this double-blind, controlled study, volunteers were randomly treated twice daily for 3 months with an active gel on one thigh and a placebo gel on the control thigh. Each thigh underwent a 15-minute treatment with LED light twice weekly (totaling 24 treatments).

At the end of the 3-month study period, investigators found alterations in cellulite warranting a downgrade in cellulite grade, based on clinical examinations, digital photography, and pinch test assessments, in eight of nine thighs treated with the phosphatidylcholine-based anticellulite gel and LED. A statistically significant decrease in immediate hypodermal depth and echolike intrusions into the dermal layer in the treated thighs was determined using digital ultrasound at the dermal-adiposal interface. Few clinical alterations were noted in the nine thighs treated with placebo and LED. Edema, erythema, and pruritus were among the rare and transient adverse effects from treatment. Follow-up at month 18 for eight response thighs revealed that five thighs regressed to their initial cellulite grade, and three thighs maintained the improvement from therapy, suggesting the need for repeated treatments (J. Cosmet. Laser Ther. 2007;9:87-96).

Given the dearth of published studies on mesotherapy with phosphatidylcholine and other ingredients, in 2007, Co et al. sought to ascertain the efficacy of phosphatidylcholine alone vs. phosphatidylcholine and organic silicium in reducing submental fat. Twelve healthy patients (of whom 1 was lost to follow-up) with submental fat received one to five treatments, with 2 weeks as the average between-treatment interval. Baseline fat measurements were taken at each session. Both treatment options were found to be equally effective, with no findings of ultrasound or histopathologic changes. Significant decreases in fat were observed after three treatment sessions in both groups, and only rare side effects (mild and fleeting) were noted. The authors identified the small sample size and the lack of a double-blind, placebo-controlled design as important limitations of the study. The researchers concluded that while the supportive evidence for using phosphatidylcholine or phosphatidylcholine with organic silicium is sparse and the mechanisms of action still poorly understood, both regimens appeared in this small study to be safe, efficacious, and inexpensive alternatives to invasive fat removal surgery (J. Cosmet. Dermatol. 2007;6:250-7).

In 2008, Salti et al. sought to assess the clinical efficacy and safety of phosphatidylcholine and sodium deoxycholate in chemical lipolysis and to characterize the roles of the agents in this nonsurgical procedure, based on reports that sodium deoxycholate, the intended excipient, was actually the active ingredient, rather than phosphatidylcholine. In the double-blind, randomized study, 37 consecutive female patients seeking treatment for cellulite received injections of a phosphatidylcholine/sodium deoxycholate preparation on one side and sodium deoxycholate on the contralateral side, for a total of four treatments every 8 weeks. The investigators recorded an overall local fat reduction of 91.9%, with no significant differences between the treatments. Side effects were local and rare, though manifested more on the sides treated with sodium deoxycholate. Both treatments were deemed safe in the short term. The authors concluded that the slower postoperative resolution associated with sodium deoxycholate suggests that this compound alone may be adequate for achieving the destruction of fat cells, while phosphatidylcholine could be used subsequently to emulsify the adipose tissue (Dermatol. Surg. 2008;34:60-6).

Concerns About Tissue Fibrosis/Necrosis

A few months later, Schuller-Petrovic et al. reported on their investigation of the subcutaneous tissue effects of phosphatidylcholine solubilized with deoxycholate in rats and one human volunteer. In a 30-day study, the rats were treated subcutaneously on the abdomen three times with 50, 300, or 600 mcL of the combination formula. The human volunteer, scheduled for elective liposuction, was treated in the same fashion. The investigators noted dose-dependent decreases in membrane integrity and cell viability in the rats, as well as histologic changes such as fibroplasia, bandlike fibrosis near the cutaneous muscle, and partial muscle loss. Fat necrosis, fat cyst development, and necrotic alterations in the walls of small blood vessels were associated with the highest dose. In the human volunteer, dose-dependent panniculitis, fat cysts, and vessel necrosis were noted in histologic sections of subcutaneous tissue. The researchers concluded that tissue fibrosis and necrosis of adipose and vascular tissues result from injection lipolysis with phosphatidylcholine/deoxycholate, and that the long-term safety profile for this nonsurgical subcutaneous fat treatment is consequently murky (Dermatol. Surg. 2008;34:529-42).

In a 2009 study of 42 patients, Rotunda et al. assessed the safety and efficacy of subcutaneously injected deoxycholate alone compared with a conventionally used phosphatidylcholine/deoxycholate combination in patients with unwanted submental fat. In this single-center, randomized, double-blind study, 28 subjects received 1-mL injections of one of the test compounds into submental fat, and 14 received 2-mL injections, with up to five treatments administered every 4 weeks. Patients completed diaries at home as well as post-treatment self-assessments. Modest changes (ranging from none to mild) in submental profiles based on photographic assessment were reported for both groups. No significant differences between the groups were seen based on patient self-assessment; physical examination; or incidence, duration, and severity of adverse events (e.g., burning, edema, erythema, and pain). The investigators reported that minimal aesthetic improvement was observed from the injection of either deoxycholate or phosphatidylcholine/deoxycholate into submental fat. They also suggested that further study is warranted based on the belief that proof of concept was supported by improved neck profiles in multiple participants. In particular, they suggested that additional work is needed to establish a validated submental profile grading scale and optimal doses and techniques (Dermatol. Surg. 2009;35:792-803).

Conclusions

Clearly, new research is slowly emerging on the use of phosphatidylcholine injections for the in-office reduction of fat deposits. The weight of this new evidence, particularly in light of the Brazilian ban on Lipostabil, strongly suggests continued optimism for the eventual use of phosphatidylcholine for fat reduction, but much more research is necessary to develop safer applications.

I would like to see larger sample sizes in randomized, placebo-controlled trials. At this point, I strongly advise against the use of Lipostabil, which, unfortunately, is available in kits sold over the Internet (lecithin and phosphatidylcholine are not regulated as drugs, though they should be, and are even sold as supplements). Several companies are working to develop safer versions of Lipostabil. I recommend that physicians advise their patients to wait until such products are vetted and validated.

Because of the seemingly endless array of topics to cover in this column, I have never directly revisited a subject here (although some botanical ingredients have received individual attention as well as some focus as members of a class of compounds). But much has changed since I last covered phosphatidylcholine in 2003. In this month’s column, I will review recent research and discuss new safety concerns regarding the use of phosphatidylcholine in mesotherapy.

Emerging about 50 years ago and popular in Europe and South America (J. Cosmet. Laser Ther. 2005;7:17-9), mesotherapy entails the subcutaneous injection of pharmaceutical, homeopathic, botanical, vitamin, or other agents with the intention of initiating localized lipolysis in cellulite or other areas with undesired fat deposits. While this is considered a noninvasive alternative to liposuction or lipectomy, the use of phosphatidylcholine for this purpose has not been approved by the U.S. Food and Drug Administration.

Off-Label Use of Phosphatidylcholine Products 

The practice of using a formulation containing soybean-derived phosphatidylcholine in mesotherapy (also called lipo-dissolve, lipotherapy, or injection lipolysis) became popular in the mid-1990s in Brazil. The substance, known as Lipostabil, is a drug that was first used to reduce triglyceride and cholesterol levels in patients with coronary artery disease. However, lipo-dissolve products are marketed in the United States as natural compounds, even though the FDA considers such substances drugs and has not approved of their use for fat removal (http://www.npr.org/templates/story/story.php?storyId=11487499). Off-label use has become increasingly common in Europe and the United States. Given a spate of complications seen after the use of Lipostabil in Brazil, ANVISA, the Brazilian equivalent of the FDA, banned the phosphatidylcholine-containing product. This should give us all pause, since it is very rare for Brazil to ban medical drugs or devices.

Phosphatidylcholine, a component of lipoproteins, is a purified extract from lecithin. It was originally used in the medical setting for emergencies and treating atheroma plaques in cardiac disease (J. Drugs Dermatol. 2003;2:511-8). This phospholipid is a major component of all cell membranes and is the primary phospholipid in plasma. Composed of choline, phosphoric acid, and fatty acids, the phosphatidylcholine molecule occurs naturally in humans (especially in nerve tissue, the liver, and semen), and is obtained through consumption of soybeans, egg yolks, meat, and, rarely, vegetables. The consumption or injection of phosphatidylcholine is believed to augment phosphatidylcholine in lipoproteins, thereby enhancing their ability to mobilize fat and cholesterol. Further, phosphatidylcholine has been demonstrated to lower systemic levels of cholesterol and triglycerides and is believed to induce lipolysis (Dermatol. Surg. 2001;27:391-2).

 Promising Findings for Use in Lipolysis

In the first paper that sparked the craze around this procedure, Rittes reported on the technique that she had begun using in 1995, with fellow Brazilian doctors. The procedure was introduced at the Dermatologic Brazilian Congress in 1999, and published in 2001 as a treatment of lower eyelid bulging caused by prominent fat pads (Dermatol. Surg. 2001;27:391-2). In the 2001 study, which featured subjective assessments of improvement and was not placebo controlled, Rittes concluded that phosphatidylcholine injections (250 mg/5 mL) into periorbital fat pads could postpone the need for or possibly substitute for lower eyelid blepharoplasty. (These findings on the use of phosphatidylcholine for correction of infraorbital fat pads were recently duplicated in an open-label study of 21 subjects conducted by Treacy and Goldberg [J. Cosmet. Laser Ther. 2006;8:129-32]).

In a 2003 study, Rittes continued to suggest that this in-office procedure was a suitable alternative to surgery, in this case lipectomy or liposuction. Specifically, 50 patients received injections of phosphatidylcholine (250 mg/5 mL) into fat deposits in the abdomen, neck, arms, or thighs in an 80-cm² area using a 30G 1/2-inch insulin needle. Rittes observed clear improvement in all patients, with a significant decline in fat deposits and no recurrence or weight gain over a 2-year follow-up (Aesthetic Plast. Surg. 2003;27:315-8).

The next year, Hexsel et al. reported on their clinical experience using 250-mg/mL phosphatidylcholine injections to treat subcutaneous fat deposits in volunteers whose injections, in various localized fat deposits, were separated by a minimum interval of 1 week and mean interval of 15 days. They found that phosphatidylcholine was efficacious in diminishing the treated fatty areas, and was accompanied by minimal side effects. The investigators concluded that this noninvasive, off-label use of phosphatidylcholine was safe, effective, and inexpensive (J. Drugs Dermatol. 2003;2:511-8).

In 2004, Rotunda et al. assessed the mechanism of action and characteristics of the active components of a clinically used, injectable fat-dissolution formulation containing phosphatidylcholine and sodium deoxycholate, a bile salt incorporated to solubilize in water the natural phospholipid. In this experiment, the investigators performed cell viability and cell membrane lysis assays on cell cultures and porcine skin after treatment with the phosphatidylcholine product, isolated sodium deoxycholate, or common laboratory detergents. In comparing the results with phosphatidylcholine and isolated sodium deoxycholate, they found a significant and comparable loss of cell viability, cell membrane lysis, and disruption of fat and musculature in cell cultures and tissue specimens. The effects generated from the laboratory detergents were similar. The investigators concluded that the popular fat-dissolution formula based on phosphatidylcholine works mainly as a detergent, inducing nonspecific cell membrane lysis. Notably, they also suggested that sodium deoxycholate was the major active constituent causing the cell lysis, and urged caution for physicians regarding this procedure pending the availability of sufficient safety data (Dermatol. Surg. 2004;30:1001-8).

In 2005, Rose and Morgan took skin biopsies, 1 and 2 weeks after mesotherapy, from a patient who had undergone the procedure with phosphatidylcholine and deoxycholate. Both biopsies revealed normal epithelium and dermis, with a mixed septal and lobular panniculitis. The investigators noted that the fat lobules were infiltrated by an elevated number of lymphocytes and macrophages, the latter of which consisted of conventional forms, foam cells, and multinucleated fat-containing giant cells. Serous atrophy and microcyst development was linked to inflammation. In this first histologic study to illustrate the mechanism of action of phosphatidylcholine and deoxycholate, the authors concluded that mesotherapy with these compounds clearly impacted subcutaneous fat. They speculated that inflammatory-mediated necrosis and resorption likely accounted for the decrease in subcutaneous fat (J. Cosmet. Laser Ther. 2005;7:17-9).

In 2007, Sasaki et al. conducted a study in nine healthy female volunteers with grade II-III thigh cellulite to determine the safety and efficacy of a phosphatidylcholine-based cosmeceutical anticellulite gel combined with light-emitting diode (LED) treatment at 660 nm (red) and 950 nm (near-infrared). In this double-blind, controlled study, volunteers were randomly treated twice daily for 3 months with an active gel on one thigh and a placebo gel on the control thigh. Each thigh underwent a 15-minute treatment with LED light twice weekly (totaling 24 treatments).

At the end of the 3-month study period, investigators found alterations in cellulite warranting a downgrade in cellulite grade, based on clinical examinations, digital photography, and pinch test assessments, in eight of nine thighs treated with the phosphatidylcholine-based anticellulite gel and LED. A statistically significant decrease in immediate hypodermal depth and echolike intrusions into the dermal layer in the treated thighs was determined using digital ultrasound at the dermal-adiposal interface. Few clinical alterations were noted in the nine thighs treated with placebo and LED. Edema, erythema, and pruritus were among the rare and transient adverse effects from treatment. Follow-up at month 18 for eight response thighs revealed that five thighs regressed to their initial cellulite grade, and three thighs maintained the improvement from therapy, suggesting the need for repeated treatments (J. Cosmet. Laser Ther. 2007;9:87-96).

Given the dearth of published studies on mesotherapy with phosphatidylcholine and other ingredients, in 2007, Co et al. sought to ascertain the efficacy of phosphatidylcholine alone vs. phosphatidylcholine and organic silicium in reducing submental fat. Twelve healthy patients (of whom 1 was lost to follow-up) with submental fat received one to five treatments, with 2 weeks as the average between-treatment interval. Baseline fat measurements were taken at each session. Both treatment options were found to be equally effective, with no findings of ultrasound or histopathologic changes. Significant decreases in fat were observed after three treatment sessions in both groups, and only rare side effects (mild and fleeting) were noted. The authors identified the small sample size and the lack of a double-blind, placebo-controlled design as important limitations of the study. The researchers concluded that while the supportive evidence for using phosphatidylcholine or phosphatidylcholine with organic silicium is sparse and the mechanisms of action still poorly understood, both regimens appeared in this small study to be safe, efficacious, and inexpensive alternatives to invasive fat removal surgery (J. Cosmet. Dermatol. 2007;6:250-7).

In 2008, Salti et al. sought to assess the clinical efficacy and safety of phosphatidylcholine and sodium deoxycholate in chemical lipolysis and to characterize the roles of the agents in this nonsurgical procedure, based on reports that sodium deoxycholate, the intended excipient, was actually the active ingredient, rather than phosphatidylcholine. In the double-blind, randomized study, 37 consecutive female patients seeking treatment for cellulite received injections of a phosphatidylcholine/sodium deoxycholate preparation on one side and sodium deoxycholate on the contralateral side, for a total of four treatments every 8 weeks. The investigators recorded an overall local fat reduction of 91.9%, with no significant differences between the treatments. Side effects were local and rare, though manifested more on the sides treated with sodium deoxycholate. Both treatments were deemed safe in the short term. The authors concluded that the slower postoperative resolution associated with sodium deoxycholate suggests that this compound alone may be adequate for achieving the destruction of fat cells, while phosphatidylcholine could be used subsequently to emulsify the adipose tissue (Dermatol. Surg. 2008;34:60-6).

Concerns About Tissue Fibrosis/Necrosis

A few months later, Schuller-Petrovic et al. reported on their investigation of the subcutaneous tissue effects of phosphatidylcholine solubilized with deoxycholate in rats and one human volunteer. In a 30-day study, the rats were treated subcutaneously on the abdomen three times with 50, 300, or 600 mcL of the combination formula. The human volunteer, scheduled for elective liposuction, was treated in the same fashion. The investigators noted dose-dependent decreases in membrane integrity and cell viability in the rats, as well as histologic changes such as fibroplasia, bandlike fibrosis near the cutaneous muscle, and partial muscle loss. Fat necrosis, fat cyst development, and necrotic alterations in the walls of small blood vessels were associated with the highest dose. In the human volunteer, dose-dependent panniculitis, fat cysts, and vessel necrosis were noted in histologic sections of subcutaneous tissue. The researchers concluded that tissue fibrosis and necrosis of adipose and vascular tissues result from injection lipolysis with phosphatidylcholine/deoxycholate, and that the long-term safety profile for this nonsurgical subcutaneous fat treatment is consequently murky (Dermatol. Surg. 2008;34:529-42).

In a 2009 study of 42 patients, Rotunda et al. assessed the safety and efficacy of subcutaneously injected deoxycholate alone compared with a conventionally used phosphatidylcholine/deoxycholate combination in patients with unwanted submental fat. In this single-center, randomized, double-blind study, 28 subjects received 1-mL injections of one of the test compounds into submental fat, and 14 received 2-mL injections, with up to five treatments administered every 4 weeks. Patients completed diaries at home as well as post-treatment self-assessments. Modest changes (ranging from none to mild) in submental profiles based on photographic assessment were reported for both groups. No significant differences between the groups were seen based on patient self-assessment; physical examination; or incidence, duration, and severity of adverse events (e.g., burning, edema, erythema, and pain). The investigators reported that minimal aesthetic improvement was observed from the injection of either deoxycholate or phosphatidylcholine/deoxycholate into submental fat. They also suggested that further study is warranted based on the belief that proof of concept was supported by improved neck profiles in multiple participants. In particular, they suggested that additional work is needed to establish a validated submental profile grading scale and optimal doses and techniques (Dermatol. Surg. 2009;35:792-803).

Conclusions

Clearly, new research is slowly emerging on the use of phosphatidylcholine injections for the in-office reduction of fat deposits. The weight of this new evidence, particularly in light of the Brazilian ban on Lipostabil, strongly suggests continued optimism for the eventual use of phosphatidylcholine for fat reduction, but much more research is necessary to develop safer applications.

I would like to see larger sample sizes in randomized, placebo-controlled trials. At this point, I strongly advise against the use of Lipostabil, which, unfortunately, is available in kits sold over the Internet (lecithin and phosphatidylcholine are not regulated as drugs, though they should be, and are even sold as supplements). Several companies are working to develop safer versions of Lipostabil. I recommend that physicians advise their patients to wait until such products are vetted and validated.

Because of the seemingly endless array of topics to cover in this column, I have never directly revisited a subject here (although some botanical ingredients have received individual attention as well as some focus as members of a class of compounds). But much has changed since I last covered phosphatidylcholine in 2003. In this month’s column, I will review recent research and discuss new safety concerns regarding the use of phosphatidylcholine in mesotherapy.

Emerging about 50 years ago and popular in Europe and South America (J. Cosmet. Laser Ther. 2005;7:17-9), mesotherapy entails the subcutaneous injection of pharmaceutical, homeopathic, botanical, vitamin, or other agents with the intention of initiating localized lipolysis in cellulite or other areas with undesired fat deposits. While this is considered a noninvasive alternative to liposuction or lipectomy, the use of phosphatidylcholine for this purpose has not been approved by the U.S. Food and Drug Administration.

Off-Label Use of Phosphatidylcholine Products 

The practice of using a formulation containing soybean-derived phosphatidylcholine in mesotherapy (also called lipo-dissolve, lipotherapy, or injection lipolysis) became popular in the mid-1990s in Brazil. The substance, known as Lipostabil, is a drug that was first used to reduce triglyceride and cholesterol levels in patients with coronary artery disease. However, lipo-dissolve products are marketed in the United States as natural compounds, even though the FDA considers such substances drugs and has not approved of their use for fat removal (http://www.npr.org/templates/story/story.php?storyId=11487499). Off-label use has become increasingly common in Europe and the United States. Given a spate of complications seen after the use of Lipostabil in Brazil, ANVISA, the Brazilian equivalent of the FDA, banned the phosphatidylcholine-containing product. This should give us all pause, since it is very rare for Brazil to ban medical drugs or devices.

Phosphatidylcholine, a component of lipoproteins, is a purified extract from lecithin. It was originally used in the medical setting for emergencies and treating atheroma plaques in cardiac disease (J. Drugs Dermatol. 2003;2:511-8). This phospholipid is a major component of all cell membranes and is the primary phospholipid in plasma. Composed of choline, phosphoric acid, and fatty acids, the phosphatidylcholine molecule occurs naturally in humans (especially in nerve tissue, the liver, and semen), and is obtained through consumption of soybeans, egg yolks, meat, and, rarely, vegetables. The consumption or injection of phosphatidylcholine is believed to augment phosphatidylcholine in lipoproteins, thereby enhancing their ability to mobilize fat and cholesterol. Further, phosphatidylcholine has been demonstrated to lower systemic levels of cholesterol and triglycerides and is believed to induce lipolysis (Dermatol. Surg. 2001;27:391-2).

 Promising Findings for Use in Lipolysis

In the first paper that sparked the craze around this procedure, Rittes reported on the technique that she had begun using in 1995, with fellow Brazilian doctors. The procedure was introduced at the Dermatologic Brazilian Congress in 1999, and published in 2001 as a treatment of lower eyelid bulging caused by prominent fat pads (Dermatol. Surg. 2001;27:391-2). In the 2001 study, which featured subjective assessments of improvement and was not placebo controlled, Rittes concluded that phosphatidylcholine injections (250 mg/5 mL) into periorbital fat pads could postpone the need for or possibly substitute for lower eyelid blepharoplasty. (These findings on the use of phosphatidylcholine for correction of infraorbital fat pads were recently duplicated in an open-label study of 21 subjects conducted by Treacy and Goldberg [J. Cosmet. Laser Ther. 2006;8:129-32]).

In a 2003 study, Rittes continued to suggest that this in-office procedure was a suitable alternative to surgery, in this case lipectomy or liposuction. Specifically, 50 patients received injections of phosphatidylcholine (250 mg/5 mL) into fat deposits in the abdomen, neck, arms, or thighs in an 80-cm² area using a 30G 1/2-inch insulin needle. Rittes observed clear improvement in all patients, with a significant decline in fat deposits and no recurrence or weight gain over a 2-year follow-up (Aesthetic Plast. Surg. 2003;27:315-8).

The next year, Hexsel et al. reported on their clinical experience using 250-mg/mL phosphatidylcholine injections to treat subcutaneous fat deposits in volunteers whose injections, in various localized fat deposits, were separated by a minimum interval of 1 week and mean interval of 15 days. They found that phosphatidylcholine was efficacious in diminishing the treated fatty areas, and was accompanied by minimal side effects. The investigators concluded that this noninvasive, off-label use of phosphatidylcholine was safe, effective, and inexpensive (J. Drugs Dermatol. 2003;2:511-8).

In 2004, Rotunda et al. assessed the mechanism of action and characteristics of the active components of a clinically used, injectable fat-dissolution formulation containing phosphatidylcholine and sodium deoxycholate, a bile salt incorporated to solubilize in water the natural phospholipid. In this experiment, the investigators performed cell viability and cell membrane lysis assays on cell cultures and porcine skin after treatment with the phosphatidylcholine product, isolated sodium deoxycholate, or common laboratory detergents. In comparing the results with phosphatidylcholine and isolated sodium deoxycholate, they found a significant and comparable loss of cell viability, cell membrane lysis, and disruption of fat and musculature in cell cultures and tissue specimens. The effects generated from the laboratory detergents were similar. The investigators concluded that the popular fat-dissolution formula based on phosphatidylcholine works mainly as a detergent, inducing nonspecific cell membrane lysis. Notably, they also suggested that sodium deoxycholate was the major active constituent causing the cell lysis, and urged caution for physicians regarding this procedure pending the availability of sufficient safety data (Dermatol. Surg. 2004;30:1001-8).

In 2005, Rose and Morgan took skin biopsies, 1 and 2 weeks after mesotherapy, from a patient who had undergone the procedure with phosphatidylcholine and deoxycholate. Both biopsies revealed normal epithelium and dermis, with a mixed septal and lobular panniculitis. The investigators noted that the fat lobules were infiltrated by an elevated number of lymphocytes and macrophages, the latter of which consisted of conventional forms, foam cells, and multinucleated fat-containing giant cells. Serous atrophy and microcyst development was linked to inflammation. In this first histologic study to illustrate the mechanism of action of phosphatidylcholine and deoxycholate, the authors concluded that mesotherapy with these compounds clearly impacted subcutaneous fat. They speculated that inflammatory-mediated necrosis and resorption likely accounted for the decrease in subcutaneous fat (J. Cosmet. Laser Ther. 2005;7:17-9).

In 2007, Sasaki et al. conducted a study in nine healthy female volunteers with grade II-III thigh cellulite to determine the safety and efficacy of a phosphatidylcholine-based cosmeceutical anticellulite gel combined with light-emitting diode (LED) treatment at 660 nm (red) and 950 nm (near-infrared). In this double-blind, controlled study, volunteers were randomly treated twice daily for 3 months with an active gel on one thigh and a placebo gel on the control thigh. Each thigh underwent a 15-minute treatment with LED light twice weekly (totaling 24 treatments).

At the end of the 3-month study period, investigators found alterations in cellulite warranting a downgrade in cellulite grade, based on clinical examinations, digital photography, and pinch test assessments, in eight of nine thighs treated with the phosphatidylcholine-based anticellulite gel and LED. A statistically significant decrease in immediate hypodermal depth and echolike intrusions into the dermal layer in the treated thighs was determined using digital ultrasound at the dermal-adiposal interface. Few clinical alterations were noted in the nine thighs treated with placebo and LED. Edema, erythema, and pruritus were among the rare and transient adverse effects from treatment. Follow-up at month 18 for eight response thighs revealed that five thighs regressed to their initial cellulite grade, and three thighs maintained the improvement from therapy, suggesting the need for repeated treatments (J. Cosmet. Laser Ther. 2007;9:87-96).

Given the dearth of published studies on mesotherapy with phosphatidylcholine and other ingredients, in 2007, Co et al. sought to ascertain the efficacy of phosphatidylcholine alone vs. phosphatidylcholine and organic silicium in reducing submental fat. Twelve healthy patients (of whom 1 was lost to follow-up) with submental fat received one to five treatments, with 2 weeks as the average between-treatment interval. Baseline fat measurements were taken at each session. Both treatment options were found to be equally effective, with no findings of ultrasound or histopathologic changes. Significant decreases in fat were observed after three treatment sessions in both groups, and only rare side effects (mild and fleeting) were noted. The authors identified the small sample size and the lack of a double-blind, placebo-controlled design as important limitations of the study. The researchers concluded that while the supportive evidence for using phosphatidylcholine or phosphatidylcholine with organic silicium is sparse and the mechanisms of action still poorly understood, both regimens appeared in this small study to be safe, efficacious, and inexpensive alternatives to invasive fat removal surgery (J. Cosmet. Dermatol. 2007;6:250-7).

In 2008, Salti et al. sought to assess the clinical efficacy and safety of phosphatidylcholine and sodium deoxycholate in chemical lipolysis and to characterize the roles of the agents in this nonsurgical procedure, based on reports that sodium deoxycholate, the intended excipient, was actually the active ingredient, rather than phosphatidylcholine. In the double-blind, randomized study, 37 consecutive female patients seeking treatment for cellulite received injections of a phosphatidylcholine/sodium deoxycholate preparation on one side and sodium deoxycholate on the contralateral side, for a total of four treatments every 8 weeks. The investigators recorded an overall local fat reduction of 91.9%, with no significant differences between the treatments. Side effects were local and rare, though manifested more on the sides treated with sodium deoxycholate. Both treatments were deemed safe in the short term. The authors concluded that the slower postoperative resolution associated with sodium deoxycholate suggests that this compound alone may be adequate for achieving the destruction of fat cells, while phosphatidylcholine could be used subsequently to emulsify the adipose tissue (Dermatol. Surg. 2008;34:60-6).

Concerns About Tissue Fibrosis/Necrosis

A few months later, Schuller-Petrovic et al. reported on their investigation of the subcutaneous tissue effects of phosphatidylcholine solubilized with deoxycholate in rats and one human volunteer. In a 30-day study, the rats were treated subcutaneously on the abdomen three times with 50, 300, or 600 mcL of the combination formula. The human volunteer, scheduled for elective liposuction, was treated in the same fashion. The investigators noted dose-dependent decreases in membrane integrity and cell viability in the rats, as well as histologic changes such as fibroplasia, bandlike fibrosis near the cutaneous muscle, and partial muscle loss. Fat necrosis, fat cyst development, and necrotic alterations in the walls of small blood vessels were associated with the highest dose. In the human volunteer, dose-dependent panniculitis, fat cysts, and vessel necrosis were noted in histologic sections of subcutaneous tissue. The researchers concluded that tissue fibrosis and necrosis of adipose and vascular tissues result from injection lipolysis with phosphatidylcholine/deoxycholate, and that the long-term safety profile for this nonsurgical subcutaneous fat treatment is consequently murky (Dermatol. Surg. 2008;34:529-42).

In a 2009 study of 42 patients, Rotunda et al. assessed the safety and efficacy of subcutaneously injected deoxycholate alone compared with a conventionally used phosphatidylcholine/deoxycholate combination in patients with unwanted submental fat. In this single-center, randomized, double-blind study, 28 subjects received 1-mL injections of one of the test compounds into submental fat, and 14 received 2-mL injections, with up to five treatments administered every 4 weeks. Patients completed diaries at home as well as post-treatment self-assessments. Modest changes (ranging from none to mild) in submental profiles based on photographic assessment were reported for both groups. No significant differences between the groups were seen based on patient self-assessment; physical examination; or incidence, duration, and severity of adverse events (e.g., burning, edema, erythema, and pain). The investigators reported that minimal aesthetic improvement was observed from the injection of either deoxycholate or phosphatidylcholine/deoxycholate into submental fat. They also suggested that further study is warranted based on the belief that proof of concept was supported by improved neck profiles in multiple participants. In particular, they suggested that additional work is needed to establish a validated submental profile grading scale and optimal doses and techniques (Dermatol. Surg. 2009;35:792-803).

Conclusions

Clearly, new research is slowly emerging on the use of phosphatidylcholine injections for the in-office reduction of fat deposits. The weight of this new evidence, particularly in light of the Brazilian ban on Lipostabil, strongly suggests continued optimism for the eventual use of phosphatidylcholine for fat reduction, but much more research is necessary to develop safer applications.

I would like to see larger sample sizes in randomized, placebo-controlled trials. At this point, I strongly advise against the use of Lipostabil, which, unfortunately, is available in kits sold over the Internet (lecithin and phosphatidylcholine are not regulated as drugs, though they should be, and are even sold as supplements). Several companies are working to develop safer versions of Lipostabil. I recommend that physicians advise their patients to wait until such products are vetted and validated.

LISBON – A novel, intradermally-injected, monophasic hyaluronic acid filler known as Belotero Intense outperformed Perlane for the treatment of moderate to deep nasolabial folds in a 12-month, double-blind, randomized trial, according to Dr. Martina Kerscher.

Merz Pharmaceuticals’ Belotero Intense is manufactured using a proprietary Cohesive Polydensified Matrix technology. The resultant product, a monophasic, polydensified hyaluronic acid filler, was designed to provide greater elasticity, less risk of lumping, and longer-lasting improvements than achievable with biphasic hyaluronic acid fillers, said Dr. Kerscher at the annual congress of the European Academy of Dermatology and Venereology.

She reported on 20 patients aged 35-65 years, with nasolabial folds (NLFs) that were grades 3-4 on a 5-point scale, meaning the defects were either moderately deep or very long and deep. Participants were randomized double-blindly to a single intradermal injection on one side of the face with Belotero Intense, while the NLFs on the other side of the face were treated with Medicis Aesthetics’ Perlane, a biphasic hyaluronic acid filler. Both products are gels of nonanimal origin. No touch-ups were permitted during the 12 months of follow-up.

Physician- and patient-rated scores on the Wrinkle Severity Rating Scale improved with both products; however, the degree of improvement was significantly greater through 24 weeks with the monophasic hyaluronic acid filler.

Belotero Intense is designed to provide greater elasticity, less risk of lumping, and longer-lasting improvements than is achievable with biphasic hyaluronic acid fillers, said Dr. Martina Kerscher.

Mean scores on the 0-4 scale went from a baseline of 4.0 to 2.4 with the biphasic filler and to 2.1 with the monophasic filler at week 2; at week 24, mean scores were 2.7 for the biphasic filler, compared with 2.4 for the monophasic filler. At week 48, however, both products showed similar effects.

Investigators and patients gave the monophasic hyaluronic acid gel higher marks on the Global Aesthetic Improvement Scale through 24 weeks. After week 24, scores for the two products merged, reported Dr. Kerscher of the University of Hamburg (Germany) division of cosmetic science.

Standardized measurements of wrinkle depth for the Belotero Intense-treated NLFs went from a baseline of 271 mm to 172 mm at week 2, 194 mm at week 24, and 213 mm at week 48. Depth of the Perlane-treated NLFs improved from 222 mm at baseline to 152 mm at week 2, 177 mm at week 24, and 184 mm at week 48. This translated to a 28% reduction in wrinkle depth at week 24 in the monophasic filler-treated lesions, compared with a 20% decrease in the biphasic filler-treated folds. The week 48 improvement was 21% in the monophasic- and 17% in the biphasic-treated NLFs.

Self-rated patient satisfaction was scored on a 0-10 scale, with a lower score showing a higher level of satisfaction. From a baseline of 7.0, scores improved to 2.3 for the biphasic filler and 2.1 for the monophasic filler at week 2, to 4.9 for biphasic and 3.8 for monophasic at week 24, and to 6.7 for biphasic and 5.7 for monophasic at week 48.

Of note, the blinded patients consistently recorded significantly less injection site pain with the monophasic hyaluronic acid filler.

Belotero Intense is licensed in the United Kingdom and several European countries as a medical device for the correction of deep folds and for volume augmentation. A sister product, Belotero Balance, earned marketing approval from the Food and Drug Administration in November 2011 for correction of moderate to severe wrinkles and folds. Belotero Intense is intended for deeper injection and correction of more pronounced defects than is Belotero Balance.

Merz is seeking FDA approval of Belotero Intense.

The study presented by Dr. Kerscher was sponsored by Merz, which markets the Belotero product line. She is a consultant to the company.

LISBON – A novel, intradermally-injected, monophasic hyaluronic acid filler known as Belotero Intense outperformed Perlane for the treatment of moderate to deep nasolabial folds in a 12-month, double-blind, randomized trial, according to Dr. Martina Kerscher.

Merz Pharmaceuticals’ Belotero Intense is manufactured using a proprietary Cohesive Polydensified Matrix technology. The resultant product, a monophasic, polydensified hyaluronic acid filler, was designed to provide greater elasticity, less risk of lumping, and longer-lasting improvements than achievable with biphasic hyaluronic acid fillers, said Dr. Kerscher at the annual congress of the European Academy of Dermatology and Venereology.

She reported on 20 patients aged 35-65 years, with nasolabial folds (NLFs) that were grades 3-4 on a 5-point scale, meaning the defects were either moderately deep or very long and deep. Participants were randomized double-blindly to a single intradermal injection on one side of the face with Belotero Intense, while the NLFs on the other side of the face were treated with Medicis Aesthetics’ Perlane, a biphasic hyaluronic acid filler. Both products are gels of nonanimal origin. No touch-ups were permitted during the 12 months of follow-up.

Physician- and patient-rated scores on the Wrinkle Severity Rating Scale improved with both products; however, the degree of improvement was significantly greater through 24 weeks with the monophasic hyaluronic acid filler.

Belotero Intense is designed to provide greater elasticity, less risk of lumping, and longer-lasting improvements than is achievable with biphasic hyaluronic acid fillers, said Dr. Martina Kerscher.

Mean scores on the 0-4 scale went from a baseline of 4.0 to 2.4 with the biphasic filler and to 2.1 with the monophasic filler at week 2; at week 24, mean scores were 2.7 for the biphasic filler, compared with 2.4 for the monophasic filler. At week 48, however, both products showed similar effects.

Investigators and patients gave the monophasic hyaluronic acid gel higher marks on the Global Aesthetic Improvement Scale through 24 weeks. After week 24, scores for the two products merged, reported Dr. Kerscher of the University of Hamburg (Germany) division of cosmetic science.

Standardized measurements of wrinkle depth for the Belotero Intense-treated NLFs went from a baseline of 271 mm to 172 mm at week 2, 194 mm at week 24, and 213 mm at week 48. Depth of the Perlane-treated NLFs improved from 222 mm at baseline to 152 mm at week 2, 177 mm at week 24, and 184 mm at week 48. This translated to a 28% reduction in wrinkle depth at week 24 in the monophasic filler-treated lesions, compared with a 20% decrease in the biphasic filler-treated folds. The week 48 improvement was 21% in the monophasic- and 17% in the biphasic-treated NLFs.

Self-rated patient satisfaction was scored on a 0-10 scale, with a lower score showing a higher level of satisfaction. From a baseline of 7.0, scores improved to 2.3 for the biphasic filler and 2.1 for the monophasic filler at week 2, to 4.9 for biphasic and 3.8 for monophasic at week 24, and to 6.7 for biphasic and 5.7 for monophasic at week 48.

Of note, the blinded patients consistently recorded significantly less injection site pain with the monophasic hyaluronic acid filler.

Belotero Intense is licensed in the United Kingdom and several European countries as a medical device for the correction of deep folds and for volume augmentation. A sister product, Belotero Balance, earned marketing approval from the Food and Drug Administration in November 2011 for correction of moderate to severe wrinkles and folds. Belotero Intense is intended for deeper injection and correction of more pronounced defects than is Belotero Balance.

Merz is seeking FDA approval of Belotero Intense.

The study presented by Dr. Kerscher was sponsored by Merz, which markets the Belotero product line. She is a consultant to the company.

LISBON – A novel, intradermally-injected, monophasic hyaluronic acid filler known as Belotero Intense outperformed Perlane for the treatment of moderate to deep nasolabial folds in a 12-month, double-blind, randomized trial, according to Dr. Martina Kerscher.

Merz Pharmaceuticals’ Belotero Intense is manufactured using a proprietary Cohesive Polydensified Matrix technology. The resultant product, a monophasic, polydensified hyaluronic acid filler, was designed to provide greater elasticity, less risk of lumping, and longer-lasting improvements than achievable with biphasic hyaluronic acid fillers, said Dr. Kerscher at the annual congress of the European Academy of Dermatology and Venereology.

She reported on 20 patients aged 35-65 years, with nasolabial folds (NLFs) that were grades 3-4 on a 5-point scale, meaning the defects were either moderately deep or very long and deep. Participants were randomized double-blindly to a single intradermal injection on one side of the face with Belotero Intense, while the NLFs on the other side of the face were treated with Medicis Aesthetics’ Perlane, a biphasic hyaluronic acid filler. Both products are gels of nonanimal origin. No touch-ups were permitted during the 12 months of follow-up.

Physician- and patient-rated scores on the Wrinkle Severity Rating Scale improved with both products; however, the degree of improvement was significantly greater through 24 weeks with the monophasic hyaluronic acid filler.

Belotero Intense is designed to provide greater elasticity, less risk of lumping, and longer-lasting improvements than is achievable with biphasic hyaluronic acid fillers, said Dr. Martina Kerscher.

Mean scores on the 0-4 scale went from a baseline of 4.0 to 2.4 with the biphasic filler and to 2.1 with the monophasic filler at week 2; at week 24, mean scores were 2.7 for the biphasic filler, compared with 2.4 for the monophasic filler. At week 48, however, both products showed similar effects.

Investigators and patients gave the monophasic hyaluronic acid gel higher marks on the Global Aesthetic Improvement Scale through 24 weeks. After week 24, scores for the two products merged, reported Dr. Kerscher of the University of Hamburg (Germany) division of cosmetic science.

Standardized measurements of wrinkle depth for the Belotero Intense-treated NLFs went from a baseline of 271 mm to 172 mm at week 2, 194 mm at week 24, and 213 mm at week 48. Depth of the Perlane-treated NLFs improved from 222 mm at baseline to 152 mm at week 2, 177 mm at week 24, and 184 mm at week 48. This translated to a 28% reduction in wrinkle depth at week 24 in the monophasic filler-treated lesions, compared with a 20% decrease in the biphasic filler-treated folds. The week 48 improvement was 21% in the monophasic- and 17% in the biphasic-treated NLFs.

Self-rated patient satisfaction was scored on a 0-10 scale, with a lower score showing a higher level of satisfaction. From a baseline of 7.0, scores improved to 2.3 for the biphasic filler and 2.1 for the monophasic filler at week 2, to 4.9 for biphasic and 3.8 for monophasic at week 24, and to 6.7 for biphasic and 5.7 for monophasic at week 48.

Of note, the blinded patients consistently recorded significantly less injection site pain with the monophasic hyaluronic acid filler.

Belotero Intense is licensed in the United Kingdom and several European countries as a medical device for the correction of deep folds and for volume augmentation. A sister product, Belotero Balance, earned marketing approval from the Food and Drug Administration in November 2011 for correction of moderate to severe wrinkles and folds. Belotero Intense is intended for deeper injection and correction of more pronounced defects than is Belotero Balance.

Merz is seeking FDA approval of Belotero Intense.

The study presented by Dr. Kerscher was sponsored by Merz, which markets the Belotero product line. She is a consultant to the company.

In this month's podcast, Reporter Naseem Miller interviews Dr. Ashley Wysong, a former six-time NCAA All-American and national champion in middle distance running, about a recent survey that found nearly half of collegiate athletes don't use sunscreen.

Dr. Sheila Fallon Friedlander discusses who should be receiving vitamin D supplementation, and Dr. Ilona Frieden says that growing evidence suggests propranolol is a "remarkably effective treatment in shrinking hemangioma growth, even in children whose hemangiomas are already fully grown in some cases."

In this month's Cosmetic Counter segment, Dr. Lily Talakoub discusses what at-home devices are worth your patient's investment. And last but not least, Dr. Alan Rockoff shares more patient-story humor.

Don't miss another episode of The Skinny Podcast; subscribe on iTunes!

In this month's podcast, Reporter Naseem Miller interviews Dr. Ashley Wysong, a former six-time NCAA All-American and national champion in middle distance running, about a recent survey that found nearly half of collegiate athletes don't use sunscreen.

Dr. Sheila Fallon Friedlander discusses who should be receiving vitamin D supplementation, and Dr. Ilona Frieden says that growing evidence suggests propranolol is a "remarkably effective treatment in shrinking hemangioma growth, even in children whose hemangiomas are already fully grown in some cases."

In this month's Cosmetic Counter segment, Dr. Lily Talakoub discusses what at-home devices are worth your patient's investment. And last but not least, Dr. Alan Rockoff shares more patient-story humor.

Don't miss another episode of The Skinny Podcast; subscribe on iTunes!

In this month's podcast, Reporter Naseem Miller interviews Dr. Ashley Wysong, a former six-time NCAA All-American and national champion in middle distance running, about a recent survey that found nearly half of collegiate athletes don't use sunscreen.

Dr. Sheila Fallon Friedlander discusses who should be receiving vitamin D supplementation, and Dr. Ilona Frieden says that growing evidence suggests propranolol is a "remarkably effective treatment in shrinking hemangioma growth, even in children whose hemangiomas are already fully grown in some cases."

In this month's Cosmetic Counter segment, Dr. Lily Talakoub discusses what at-home devices are worth your patient's investment. And last but not least, Dr. Alan Rockoff shares more patient-story humor.

Don't miss another episode of The Skinny Podcast; subscribe on iTunes!

LISBON – The tower technique is a novel method of injecting hyaluronic acid fillers that is particularly well suited for anatomic locations where underlying structural support for soft tissue has been lost because of aging.

The tower technique creates a deep base of scaffolding that extends through the entire subcutis. It reintroduces lost structural support for the overlying facial soft tissue rather than simply filling lines, Dr. C. William Hanke explained in a plenary lecture at the annual congress of the European Academy of Dermatology and Venereology.

"The Big Three with facial aging are skin quality, facial volume, and laxity. Volume trumps the other two. ... You can improve skin quality and laxity with volume alone," said Dr. Hanke of the Laser and Skin Surgery Center of Indiana, Carmel.

Areas particularly amenable to the tower technique include the nasolabial folds, marionette lines, the brow region, the chin compartment, and the prejowl sulcus. The best areas in which to employ the tower technique have underlying bony structural support, a thick subcutis, or an overlying thick dermis.

The technique is easily mastered, he said. "You take your syringe of hyaluronic acid and point it straight down at the bone, perpendicular, and then you inject as you withdraw. You deposit decreasing amounts of the filler as you withdraw the needle, creating a pyramid-like tower," he explained. "This is really an amazing thing in that it props up the skin right before your eyes. It’s minimally painful, there are a minimum number of injections, and the complications – such as bruising – are very minimal as well."

Dr. Hanke generally utilizes 30-gauge half-inch needles for the injections. For a nasolabial fold or superior marionette line he creates two or three towers, injecting 0.1-0.2 mL of filler into each. Inferior marionette lines get one or two towers, with 0.1-0.3 mL of product placed in each. The lateral brow lift entails two or three towers, each with 0.1 mL of filler.

Restoring support of the mental area requires one to three towers, each constructed of 0.2-0.3 mL of filler placed from the periosteum to the deep dermis. The prejowl sulcus can be shored up with one or two towers, each containing 0.2-0.3 mL of filler.

The tower technique is for use with hyaluronic acid fillers. It’s not appropriate for poly-L-lactic acid or calcium hydroxyapatite fillers, which need to be placed deeper or in a single plane.

Dr. Hanke noted that he didn’t come up with the tower technique.

"I first heard about it in Germany. I think other people were using it, too. I’ve [also] heard about this technique from the Canadians. They call it the tent pole technique," he said.

Dr. Hanke and his colleagues recently wrote a detailed how-to guide to the tower technique (J. Drugs Dermatol. 2011;10:1277-80).

He reported having no relevant financial interests.

LISBON – The tower technique is a novel method of injecting hyaluronic acid fillers that is particularly well suited for anatomic locations where underlying structural support for soft tissue has been lost because of aging.

The tower technique creates a deep base of scaffolding that extends through the entire subcutis. It reintroduces lost structural support for the overlying facial soft tissue rather than simply filling lines, Dr. C. William Hanke explained in a plenary lecture at the annual congress of the European Academy of Dermatology and Venereology.

"The Big Three with facial aging are skin quality, facial volume, and laxity. Volume trumps the other two. ... You can improve skin quality and laxity with volume alone," said Dr. Hanke of the Laser and Skin Surgery Center of Indiana, Carmel.

Areas particularly amenable to the tower technique include the nasolabial folds, marionette lines, the brow region, the chin compartment, and the prejowl sulcus. The best areas in which to employ the tower technique have underlying bony structural support, a thick subcutis, or an overlying thick dermis.

The technique is easily mastered, he said. "You take your syringe of hyaluronic acid and point it straight down at the bone, perpendicular, and then you inject as you withdraw. You deposit decreasing amounts of the filler as you withdraw the needle, creating a pyramid-like tower," he explained. "This is really an amazing thing in that it props up the skin right before your eyes. It’s minimally painful, there are a minimum number of injections, and the complications – such as bruising – are very minimal as well."

Dr. Hanke generally utilizes 30-gauge half-inch needles for the injections. For a nasolabial fold or superior marionette line he creates two or three towers, injecting 0.1-0.2 mL of filler into each. Inferior marionette lines get one or two towers, with 0.1-0.3 mL of product placed in each. The lateral brow lift entails two or three towers, each with 0.1 mL of filler.

Restoring support of the mental area requires one to three towers, each constructed of 0.2-0.3 mL of filler placed from the periosteum to the deep dermis. The prejowl sulcus can be shored up with one or two towers, each containing 0.2-0.3 mL of filler.

The tower technique is for use with hyaluronic acid fillers. It’s not appropriate for poly-L-lactic acid or calcium hydroxyapatite fillers, which need to be placed deeper or in a single plane.

Dr. Hanke noted that he didn’t come up with the tower technique.

"I first heard about it in Germany. I think other people were using it, too. I’ve [also] heard about this technique from the Canadians. They call it the tent pole technique," he said.

Dr. Hanke and his colleagues recently wrote a detailed how-to guide to the tower technique (J. Drugs Dermatol. 2011;10:1277-80).

He reported having no relevant financial interests.

LISBON – The tower technique is a novel method of injecting hyaluronic acid fillers that is particularly well suited for anatomic locations where underlying structural support for soft tissue has been lost because of aging.

The tower technique creates a deep base of scaffolding that extends through the entire subcutis. It reintroduces lost structural support for the overlying facial soft tissue rather than simply filling lines, Dr. C. William Hanke explained in a plenary lecture at the annual congress of the European Academy of Dermatology and Venereology.

"The Big Three with facial aging are skin quality, facial volume, and laxity. Volume trumps the other two. ... You can improve skin quality and laxity with volume alone," said Dr. Hanke of the Laser and Skin Surgery Center of Indiana, Carmel.

Areas particularly amenable to the tower technique include the nasolabial folds, marionette lines, the brow region, the chin compartment, and the prejowl sulcus. The best areas in which to employ the tower technique have underlying bony structural support, a thick subcutis, or an overlying thick dermis.

The technique is easily mastered, he said. "You take your syringe of hyaluronic acid and point it straight down at the bone, perpendicular, and then you inject as you withdraw. You deposit decreasing amounts of the filler as you withdraw the needle, creating a pyramid-like tower," he explained. "This is really an amazing thing in that it props up the skin right before your eyes. It’s minimally painful, there are a minimum number of injections, and the complications – such as bruising – are very minimal as well."

Dr. Hanke generally utilizes 30-gauge half-inch needles for the injections. For a nasolabial fold or superior marionette line he creates two or three towers, injecting 0.1-0.2 mL of filler into each. Inferior marionette lines get one or two towers, with 0.1-0.3 mL of product placed in each. The lateral brow lift entails two or three towers, each with 0.1 mL of filler.

Restoring support of the mental area requires one to three towers, each constructed of 0.2-0.3 mL of filler placed from the periosteum to the deep dermis. The prejowl sulcus can be shored up with one or two towers, each containing 0.2-0.3 mL of filler.

The tower technique is for use with hyaluronic acid fillers. It’s not appropriate for poly-L-lactic acid or calcium hydroxyapatite fillers, which need to be placed deeper or in a single plane.

Dr. Hanke noted that he didn’t come up with the tower technique.

"I first heard about it in Germany. I think other people were using it, too. I’ve [also] heard about this technique from the Canadians. They call it the tent pole technique," he said.

Dr. Hanke and his colleagues recently wrote a detailed how-to guide to the tower technique (J. Drugs Dermatol. 2011;10:1277-80).

He reported having no relevant financial interests.

ORLANDO – One number keeps coming up with the new autologous fibroblast biologic product that enhances a patient’s nasolabial wrinkles: three.

"There are a lot of threes: three biopsies 3 mm in size, a 3 month’s wait, and three treatment sessions," Dr. Robert Weiss said at the annual meeting of the Florida Society of Dermatology Surgeons.

The Food and Drug Administration cleared the marketing of Fibrocell Science’s azficel-T (LaVív) in June 2011, and the product is now reaching the market. "It’s very exciting to be right at the launch of this," said Dr .Weiss, a dermatologist in private practice in Hunt Valley, Md., and with the dermatology department at Johns Hopkins University, Baltimore. "I’ve been working on this for close to a decade, so it was a personal triumph to see this finally cleared by the FDA."

The FDA based its clearance on two identically designed, multicenter, double-blind, vehicle-controlled studies. A total of 421 patients with moderate to severe nasolabial fold wrinkles were assessed, with 210 being randomized to azficel-T and 211 to vehicle injections. The average age was 55 years, and 90% were women.

A 2-point improvement in the appearance of the nasolabial fold wrinkles was the primary outcome. Physicians at the study sites who were not injectors blindly rated results.

At the 6-month follow-up, doctors observed the 2-point improvement in 33% of the azficel-T group, compared with 7% of controls in the first study. In the second study, 19% of the azficel-T group had at least a 2-point improvement, compared with 7% of controls. These differences were on the borderline of statistical significance, Dr. Weiss said.

"The FDA was convinced that this was effective. We were certainly very convinced by what we observed with the patients," Dr. Weiss said.

Patient reported outcomes were more statistically significant, with 57% reporting a 2-point improvement, compared with 30% in the vehicle group in an intent-to-treat analysis of the first study. In the second study, 45% of the treated patients reported this outcome, compared with 18% of the vehicle group.

The most common adverse effects were injection site reactions lasting approximately 2 hours, Dr. Weiss said. These events included erythema, bruising, and swelling. Facial or eyelid edema, hypersensitivity or decreased skin sensation at the injection site, and postprocedural discomfort were among the adverse events reported by 1% of patients or fewer.

"One of the first questions patients ask me is: ‘How are you going to make sure I’m getting my own cells?’ " Dr. Weiss explained there are strict controls. Each patient is assigned a lot number. Vials for injection are labeled with each patient’s initials, date of birth, and a unique identification number. "All the critical steps are verified twice."

The treatment protocol involves extraction, purification, culturing, and injection. Dr. Weiss said he injects 1 cc to 2 cc of lidocaine in the postauricular area before taking the biopsies. The tissue is sent to Fibrocell for purification and culturing of the fibroblasts.

After 3 months, a vial containing 15 million to 20 million fibroblasts is shipped back to arrive just prior to the patient appointment. "Advise your patients that advance notice of at least 2 business days is required to reschedule treatment. By the FDA guidelines, you cannot inject the cells the next day because the viability count goes down." Treatment at 3- to 6-week intervals is recommended.

Because the product is a biologic, the FDA requires physician certification prior to use of azficel-T. "If you are interested in offering this to your patients, the company will train your staff. There are webinars," Dr. Weiss said. Staff training reinforces proper packing, handling, and shipping.

The product has to be handled gingerly and injected superficially in the papillary dermis, he said. "This is for superficial rhytids; this is not a deep volume filler." The needle will be visible under the skin if you are injecting in the right plane.

Resuspend the cells by inverting the vial slowly a few times. Be careful putting the vial on the tray because it can fall over. Apply light pressure to the plunger and inject slowly along the wrinkle line.

Instruct the patient not to wash the site for 24 hours and not to scrub, rub, massage, or apply any pressure for 72 hours. An NSAID can be taken for pain.

Also, instruct patients to call if they experience any adverse reactions. Fibrocell plans to launch a patient registry in July 2012 that will track hypersensitivity reactions.

Dr. Weiss participated in one of the clinical trials as early as 2003. "What we’ve noted on long-term follow-up is that patients maintain this improvement, often for many, many years, which is interesting."

"I’ve seen some phenomenal results, particularly in studies of acne scars, which is another potential application the company is applying for," he added.

Dr. Weiss has been an investigator for Fibrocell Science, which sponsored his presentation.

ORLANDO – One number keeps coming up with the new autologous fibroblast biologic product that enhances a patient’s nasolabial wrinkles: three.

"There are a lot of threes: three biopsies 3 mm in size, a 3 month’s wait, and three treatment sessions," Dr. Robert Weiss said at the annual meeting of the Florida Society of Dermatology Surgeons.

The Food and Drug Administration cleared the marketing of Fibrocell Science’s azficel-T (LaVív) in June 2011, and the product is now reaching the market. "It’s very exciting to be right at the launch of this," said Dr .Weiss, a dermatologist in private practice in Hunt Valley, Md., and with the dermatology department at Johns Hopkins University, Baltimore. "I’ve been working on this for close to a decade, so it was a personal triumph to see this finally cleared by the FDA."

The FDA based its clearance on two identically designed, multicenter, double-blind, vehicle-controlled studies. A total of 421 patients with moderate to severe nasolabial fold wrinkles were assessed, with 210 being randomized to azficel-T and 211 to vehicle injections. The average age was 55 years, and 90% were women.

A 2-point improvement in the appearance of the nasolabial fold wrinkles was the primary outcome. Physicians at the study sites who were not injectors blindly rated results.

At the 6-month follow-up, doctors observed the 2-point improvement in 33% of the azficel-T group, compared with 7% of controls in the first study. In the second study, 19% of the azficel-T group had at least a 2-point improvement, compared with 7% of controls. These differences were on the borderline of statistical significance, Dr. Weiss said.

"The FDA was convinced that this was effective. We were certainly very convinced by what we observed with the patients," Dr. Weiss said.

Patient reported outcomes were more statistically significant, with 57% reporting a 2-point improvement, compared with 30% in the vehicle group in an intent-to-treat analysis of the first study. In the second study, 45% of the treated patients reported this outcome, compared with 18% of the vehicle group.

The most common adverse effects were injection site reactions lasting approximately 2 hours, Dr. Weiss said. These events included erythema, bruising, and swelling. Facial or eyelid edema, hypersensitivity or decreased skin sensation at the injection site, and postprocedural discomfort were among the adverse events reported by 1% of patients or fewer.

"One of the first questions patients ask me is: ‘How are you going to make sure I’m getting my own cells?’ " Dr. Weiss explained there are strict controls. Each patient is assigned a lot number. Vials for injection are labeled with each patient’s initials, date of birth, and a unique identification number. "All the critical steps are verified twice."

The treatment protocol involves extraction, purification, culturing, and injection. Dr. Weiss said he injects 1 cc to 2 cc of lidocaine in the postauricular area before taking the biopsies. The tissue is sent to Fibrocell for purification and culturing of the fibroblasts.

After 3 months, a vial containing 15 million to 20 million fibroblasts is shipped back to arrive just prior to the patient appointment. "Advise your patients that advance notice of at least 2 business days is required to reschedule treatment. By the FDA guidelines, you cannot inject the cells the next day because the viability count goes down." Treatment at 3- to 6-week intervals is recommended.

Because the product is a biologic, the FDA requires physician certification prior to use of azficel-T. "If you are interested in offering this to your patients, the company will train your staff. There are webinars," Dr. Weiss said. Staff training reinforces proper packing, handling, and shipping.

The product has to be handled gingerly and injected superficially in the papillary dermis, he said. "This is for superficial rhytids; this is not a deep volume filler." The needle will be visible under the skin if you are injecting in the right plane.

Resuspend the cells by inverting the vial slowly a few times. Be careful putting the vial on the tray because it can fall over. Apply light pressure to the plunger and inject slowly along the wrinkle line.

Instruct the patient not to wash the site for 24 hours and not to scrub, rub, massage, or apply any pressure for 72 hours. An NSAID can be taken for pain.

Also, instruct patients to call if they experience any adverse reactions. Fibrocell plans to launch a patient registry in July 2012 that will track hypersensitivity reactions.

Dr. Weiss participated in one of the clinical trials as early as 2003. "What we’ve noted on long-term follow-up is that patients maintain this improvement, often for many, many years, which is interesting."

"I’ve seen some phenomenal results, particularly in studies of acne scars, which is another potential application the company is applying for," he added.

Dr. Weiss has been an investigator for Fibrocell Science, which sponsored his presentation.

ORLANDO – One number keeps coming up with the new autologous fibroblast biologic product that enhances a patient’s nasolabial wrinkles: three.

"There are a lot of threes: three biopsies 3 mm in size, a 3 month’s wait, and three treatment sessions," Dr. Robert Weiss said at the annual meeting of the Florida Society of Dermatology Surgeons.

The Food and Drug Administration cleared the marketing of Fibrocell Science’s azficel-T (LaVív) in June 2011, and the product is now reaching the market. "It’s very exciting to be right at the launch of this," said Dr .Weiss, a dermatologist in private practice in Hunt Valley, Md., and with the dermatology department at Johns Hopkins University, Baltimore. "I’ve been working on this for close to a decade, so it was a personal triumph to see this finally cleared by the FDA."

The FDA based its clearance on two identically designed, multicenter, double-blind, vehicle-controlled studies. A total of 421 patients with moderate to severe nasolabial fold wrinkles were assessed, with 210 being randomized to azficel-T and 211 to vehicle injections. The average age was 55 years, and 90% were women.

A 2-point improvement in the appearance of the nasolabial fold wrinkles was the primary outcome. Physicians at the study sites who were not injectors blindly rated results.

At the 6-month follow-up, doctors observed the 2-point improvement in 33% of the azficel-T group, compared with 7% of controls in the first study. In the second study, 19% of the azficel-T group had at least a 2-point improvement, compared with 7% of controls. These differences were on the borderline of statistical significance, Dr. Weiss said.

"The FDA was convinced that this was effective. We were certainly very convinced by what we observed with the patients," Dr. Weiss said.

Patient reported outcomes were more statistically significant, with 57% reporting a 2-point improvement, compared with 30% in the vehicle group in an intent-to-treat analysis of the first study. In the second study, 45% of the treated patients reported this outcome, compared with 18% of the vehicle group.

The most common adverse effects were injection site reactions lasting approximately 2 hours, Dr. Weiss said. These events included erythema, bruising, and swelling. Facial or eyelid edema, hypersensitivity or decreased skin sensation at the injection site, and postprocedural discomfort were among the adverse events reported by 1% of patients or fewer.

"One of the first questions patients ask me is: ‘How are you going to make sure I’m getting my own cells?’ " Dr. Weiss explained there are strict controls. Each patient is assigned a lot number. Vials for injection are labeled with each patient’s initials, date of birth, and a unique identification number. "All the critical steps are verified twice."

The treatment protocol involves extraction, purification, culturing, and injection. Dr. Weiss said he injects 1 cc to 2 cc of lidocaine in the postauricular area before taking the biopsies. The tissue is sent to Fibrocell for purification and culturing of the fibroblasts.

After 3 months, a vial containing 15 million to 20 million fibroblasts is shipped back to arrive just prior to the patient appointment. "Advise your patients that advance notice of at least 2 business days is required to reschedule treatment. By the FDA guidelines, you cannot inject the cells the next day because the viability count goes down." Treatment at 3- to 6-week intervals is recommended.

Because the product is a biologic, the FDA requires physician certification prior to use of azficel-T. "If you are interested in offering this to your patients, the company will train your staff. There are webinars," Dr. Weiss said. Staff training reinforces proper packing, handling, and shipping.

The product has to be handled gingerly and injected superficially in the papillary dermis, he said. "This is for superficial rhytids; this is not a deep volume filler." The needle will be visible under the skin if you are injecting in the right plane.

Resuspend the cells by inverting the vial slowly a few times. Be careful putting the vial on the tray because it can fall over. Apply light pressure to the plunger and inject slowly along the wrinkle line.

Instruct the patient not to wash the site for 24 hours and not to scrub, rub, massage, or apply any pressure for 72 hours. An NSAID can be taken for pain.

Also, instruct patients to call if they experience any adverse reactions. Fibrocell plans to launch a patient registry in July 2012 that will track hypersensitivity reactions.

Dr. Weiss participated in one of the clinical trials as early as 2003. "What we’ve noted on long-term follow-up is that patients maintain this improvement, often for many, many years, which is interesting."

"I’ve seen some phenomenal results, particularly in studies of acne scars, which is another potential application the company is applying for," he added.

Dr. Weiss has been an investigator for Fibrocell Science, which sponsored his presentation.

SAN DIEGO – It would be somewhat of an understatement to say that Mohs surgery was not particularly welcomed at hospitals where Dr. Rainer Sachse used to practice.

As a plastic and reconstructive surgeon, he had hoped to utilize the technique to treat extensive, high-stage tumors in high-risk patients within a hospital setting, believing that the literature convincingly suggested that Mohs offered the best hope for cancer control in such patients.

Nurses, he recalled, considered Mohs a "slow, mutilating, expensive" procedure. Surgeons felt it was unnecessary. Pathologists thought their traditional methods "worked perfectly well."

Dermatologists seemed preoccupied by turf battles between the American Society for Mohs Surgery (ASMS) and the American College of Mohs Surgery. Dermatology residents had no time, and plastic surgery residents were uninterested, Dr. Sachse said at the meeting sponsored by the ASMS.

He pressed on, though, inspired by cases in which conventional excisions and standard therapy mutilated patients or led to their untimely deaths from tumors with continuous growth patterns.

He observed colleagues and sought out preceptorships, pored over the literature, and took a Mohs surgery course before beginning to try small cases with a pathologist who had received dermatopathology training. Finally, he began to change minds and take on more challenging cases.

Seeing the results, "a pathologist who was initially very skeptical eventually became a strong supporter," said Dr. Sachse, who is in private practice in Fort Lauderdale, Fla.

Hospital-based Mohs surgery has a role in the treatment of "psychologically problematic" patients, including those with severe anxiety and/or dementia; patients with high-risk medical conditions, including ischemic heart disease, severe arrhythmias, significant pulmonary insufficiencies, or coagulopathies; the physical handicapped; and the morbidly obese, he said.

Additionally, some hospitalized patients require urgent care, what Dr. Sachse terms "emergency Mohs surgery." He offered, as an example, a leukemia patient with skin necrosis of the scalp that was doubling in size every 24 hours. A biopsy revealed that the patient had a zygomycete fungal infection.

Mohs micrographic surgery was followed by topical and oral antifungal therapy and, after a delay, a skin graft, for a clinically and aesthetically acceptable result, he said.

With unusual and complex cases, it is important to build teamwork within the hospital since a multispecialty approach is necessary for cases that invade multiple structures of the head and neck, said Dr. Sachse.

In such cases, the concept of complete margin control must be emphasized, since many colleagues in otolaryngology, plastic surgery, and pathology will be unfamiliar with the basic tenets of the approach and the precision required to achieving those goals, he noted.

He learned to counter perceptions of Mohs surgery as tedious and slow by using careful planning and documentation of results in patients who might have been previously considered inoperable.

Education helps, as does realistic scheduling of operating rooms for the time required for extensive debridement, meticulous staging, excision, and repair.

Presenting Mohs cases to a hospital tumor board can be illuminating to the uninitiated, and the cases themselves are "very rewarding," he said.

Dr. Sachse cautioned that surgeons taking on highly complex cases should "be prepared to meet a patient you may not be able to cure." That said, "Mohs is a surgical tool which can and should be used for very extensive tumors. The complexity of the margins may increase exponentially, but you can always cut quicker than any tumor can grow."

Dr. Sachse said that he had no relevant disclosures.

SAN DIEGO – It would be somewhat of an understatement to say that Mohs surgery was not particularly welcomed at hospitals where Dr. Rainer Sachse used to practice.

As a plastic and reconstructive surgeon, he had hoped to utilize the technique to treat extensive, high-stage tumors in high-risk patients within a hospital setting, believing that the literature convincingly suggested that Mohs offered the best hope for cancer control in such patients.

Nurses, he recalled, considered Mohs a "slow, mutilating, expensive" procedure. Surgeons felt it was unnecessary. Pathologists thought their traditional methods "worked perfectly well."

Dermatologists seemed preoccupied by turf battles between the American Society for Mohs Surgery (ASMS) and the American College of Mohs Surgery. Dermatology residents had no time, and plastic surgery residents were uninterested, Dr. Sachse said at the meeting sponsored by the ASMS.

He pressed on, though, inspired by cases in which conventional excisions and standard therapy mutilated patients or led to their untimely deaths from tumors with continuous growth patterns.

He observed colleagues and sought out preceptorships, pored over the literature, and took a Mohs surgery course before beginning to try small cases with a pathologist who had received dermatopathology training. Finally, he began to change minds and take on more challenging cases.

Seeing the results, "a pathologist who was initially very skeptical eventually became a strong supporter," said Dr. Sachse, who is in private practice in Fort Lauderdale, Fla.

Hospital-based Mohs surgery has a role in the treatment of "psychologically problematic" patients, including those with severe anxiety and/or dementia; patients with high-risk medical conditions, including ischemic heart disease, severe arrhythmias, significant pulmonary insufficiencies, or coagulopathies; the physical handicapped; and the morbidly obese, he said.

Additionally, some hospitalized patients require urgent care, what Dr. Sachse terms "emergency Mohs surgery." He offered, as an example, a leukemia patient with skin necrosis of the scalp that was doubling in size every 24 hours. A biopsy revealed that the patient had a zygomycete fungal infection.

Mohs micrographic surgery was followed by topical and oral antifungal therapy and, after a delay, a skin graft, for a clinically and aesthetically acceptable result, he said.

With unusual and complex cases, it is important to build teamwork within the hospital since a multispecialty approach is necessary for cases that invade multiple structures of the head and neck, said Dr. Sachse.

In such cases, the concept of complete margin control must be emphasized, since many colleagues in otolaryngology, plastic surgery, and pathology will be unfamiliar with the basic tenets of the approach and the precision required to achieving those goals, he noted.

He learned to counter perceptions of Mohs surgery as tedious and slow by using careful planning and documentation of results in patients who might have been previously considered inoperable.

Education helps, as does realistic scheduling of operating rooms for the time required for extensive debridement, meticulous staging, excision, and repair.

Presenting Mohs cases to a hospital tumor board can be illuminating to the uninitiated, and the cases themselves are "very rewarding," he said.

Dr. Sachse cautioned that surgeons taking on highly complex cases should "be prepared to meet a patient you may not be able to cure." That said, "Mohs is a surgical tool which can and should be used for very extensive tumors. The complexity of the margins may increase exponentially, but you can always cut quicker than any tumor can grow."

Dr. Sachse said that he had no relevant disclosures.

SAN DIEGO – It would be somewhat of an understatement to say that Mohs surgery was not particularly welcomed at hospitals where Dr. Rainer Sachse used to practice.

As a plastic and reconstructive surgeon, he had hoped to utilize the technique to treat extensive, high-stage tumors in high-risk patients within a hospital setting, believing that the literature convincingly suggested that Mohs offered the best hope for cancer control in such patients.

Nurses, he recalled, considered Mohs a "slow, mutilating, expensive" procedure. Surgeons felt it was unnecessary. Pathologists thought their traditional methods "worked perfectly well."

Dermatologists seemed preoccupied by turf battles between the American Society for Mohs Surgery (ASMS) and the American College of Mohs Surgery. Dermatology residents had no time, and plastic surgery residents were uninterested, Dr. Sachse said at the meeting sponsored by the ASMS.

He pressed on, though, inspired by cases in which conventional excisions and standard therapy mutilated patients or led to their untimely deaths from tumors with continuous growth patterns.

He observed colleagues and sought out preceptorships, pored over the literature, and took a Mohs surgery course before beginning to try small cases with a pathologist who had received dermatopathology training. Finally, he began to change minds and take on more challenging cases.

Seeing the results, "a pathologist who was initially very skeptical eventually became a strong supporter," said Dr. Sachse, who is in private practice in Fort Lauderdale, Fla.

Hospital-based Mohs surgery has a role in the treatment of "psychologically problematic" patients, including those with severe anxiety and/or dementia; patients with high-risk medical conditions, including ischemic heart disease, severe arrhythmias, significant pulmonary insufficiencies, or coagulopathies; the physical handicapped; and the morbidly obese, he said.

Additionally, some hospitalized patients require urgent care, what Dr. Sachse terms "emergency Mohs surgery." He offered, as an example, a leukemia patient with skin necrosis of the scalp that was doubling in size every 24 hours. A biopsy revealed that the patient had a zygomycete fungal infection.

Mohs micrographic surgery was followed by topical and oral antifungal therapy and, after a delay, a skin graft, for a clinically and aesthetically acceptable result, he said.

With unusual and complex cases, it is important to build teamwork within the hospital since a multispecialty approach is necessary for cases that invade multiple structures of the head and neck, said Dr. Sachse.

In such cases, the concept of complete margin control must be emphasized, since many colleagues in otolaryngology, plastic surgery, and pathology will be unfamiliar with the basic tenets of the approach and the precision required to achieving those goals, he noted.

He learned to counter perceptions of Mohs surgery as tedious and slow by using careful planning and documentation of results in patients who might have been previously considered inoperable.

Education helps, as does realistic scheduling of operating rooms for the time required for extensive debridement, meticulous staging, excision, and repair.

Presenting Mohs cases to a hospital tumor board can be illuminating to the uninitiated, and the cases themselves are "very rewarding," he said.

Dr. Sachse cautioned that surgeons taking on highly complex cases should "be prepared to meet a patient you may not be able to cure." That said, "Mohs is a surgical tool which can and should be used for very extensive tumors. The complexity of the margins may increase exponentially, but you can always cut quicker than any tumor can grow."

Dr. Sachse said that he had no relevant disclosures.