Doug Brunk

LAS VEGAS — Although Botox has enjoyed a top-notch safety and efficacy record for nearly 2 decades, a mouse study published in the Journal of Neuroscience piqued the interest of Dr. Jean D.A. Carruthers, who, with her husband, Dr. Alastair Carruthers, pioneered the cosmetic use of botulinum toxin type A.

For the study, Italian investigators injected a research neurotoxin into the rat whiskers and found that it cleaved SNAP-25 (synaptosomal-associated protein, 25 kDa) in the seventh cranial nerve nucleus (J. Neurosci. 2008;28:3689–96).

In two other experiments, hippocampal injection of the neurotoxin crossed to the opposite hippocampus, whereas tectal injection led to cleaved SNAP-25 in the opposite retina.

"This is fascinating, because it's never been shown before that neurotoxin can migrate toward the brain or away from the brain," Dr. Carruthers said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "However, they were using enormous doses compared with our human dosing; it's like a fire hose compared to a drip. [There haven't been] any human data to support this."

She did, however, note some published studies that demonstrated that a glabellar injection of Botox improves mood and helps people cope with their depression and anxiety, "so maybe there is something happening there. Maybe this opens up a new area for research. But in 25 years of clinical use, there haven't been studies that show there are intracranial abnormalities. There is something going on here that requires different analysis and more study."

In 2005 Dr. Carruthers, a Vancouver-based ophthalmologist and oculoplastic surgeon, and her husband, a dermatologist and dermatologic surgeon, performed a long-term safety study of 50 subjects after a minimum of 5 years since their initial Botox treatment. "They'd had at least 10 treatment sessions; these weren't novices," she said.

The mean age of the patients was 42 years, and 92% were female.

Of 851 treatment sessions, there were three cases of brow ptosis in two subjects, one case of eyelid ptosis, and one case of dysphagia. "All of the side effects were mild and transient," said Dr. Carruthers, also of the department of ophthalmology at the University of British Columbia, Vancouver, where she specializes in facial cosmetic surgery. "None of the patients were particularly concerned about the adverse events because they all settled down."

A systematic review and meta-analysis of 36 studies of 2,309 subjects yielded similar results (J. Curr. Med. Res. Opin. 2004;20:981–90). Mild to moderate adverse events occurred in 25% of the Botox-treated group, compared with 15% for placebo. Focal weakness was the only adverse event with significantly higher incidence in the Botox-treated group. No serious adverse events were reported.

Transient, local complications "are what we want to continue seeing from the use of Botox," she said. "Immunogenicity is an overstated problem. Use only [Food and Drug Administration]-approved toxins, even for off-label indications."

She concluded that Botox is "a great drug that we should have great respect for. So when we see reports of serious adverse events, let's find out if it is Botox or if it's something else that's being used in a nonapproved way. Remember that there is nearly 20 years of Botox safety in worldwide publications."

Dr. Carruthers disclosed that she has relevant relationships with a number of pharmaceutical and medical device companies, including Allergan Inc. and Bioform Medical Inc.

LAS VEGAS — Although Botox has enjoyed a top-notch safety and efficacy record for nearly 2 decades, a mouse study published in the Journal of Neuroscience piqued the interest of Dr. Jean D.A. Carruthers, who, with her husband, Dr. Alastair Carruthers, pioneered the cosmetic use of botulinum toxin type A.

For the study, Italian investigators injected a research neurotoxin into the rat whiskers and found that it cleaved SNAP-25 (synaptosomal-associated protein, 25 kDa) in the seventh cranial nerve nucleus (J. Neurosci. 2008;28:3689–96).

In two other experiments, hippocampal injection of the neurotoxin crossed to the opposite hippocampus, whereas tectal injection led to cleaved SNAP-25 in the opposite retina.

"This is fascinating, because it's never been shown before that neurotoxin can migrate toward the brain or away from the brain," Dr. Carruthers said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "However, they were using enormous doses compared with our human dosing; it's like a fire hose compared to a drip. [There haven't been] any human data to support this."

She did, however, note some published studies that demonstrated that a glabellar injection of Botox improves mood and helps people cope with their depression and anxiety, "so maybe there is something happening there. Maybe this opens up a new area for research. But in 25 years of clinical use, there haven't been studies that show there are intracranial abnormalities. There is something going on here that requires different analysis and more study."

In 2005 Dr. Carruthers, a Vancouver-based ophthalmologist and oculoplastic surgeon, and her husband, a dermatologist and dermatologic surgeon, performed a long-term safety study of 50 subjects after a minimum of 5 years since their initial Botox treatment. "They'd had at least 10 treatment sessions; these weren't novices," she said.

The mean age of the patients was 42 years, and 92% were female.

Of 851 treatment sessions, there were three cases of brow ptosis in two subjects, one case of eyelid ptosis, and one case of dysphagia. "All of the side effects were mild and transient," said Dr. Carruthers, also of the department of ophthalmology at the University of British Columbia, Vancouver, where she specializes in facial cosmetic surgery. "None of the patients were particularly concerned about the adverse events because they all settled down."

A systematic review and meta-analysis of 36 studies of 2,309 subjects yielded similar results (J. Curr. Med. Res. Opin. 2004;20:981–90). Mild to moderate adverse events occurred in 25% of the Botox-treated group, compared with 15% for placebo. Focal weakness was the only adverse event with significantly higher incidence in the Botox-treated group. No serious adverse events were reported.

Transient, local complications "are what we want to continue seeing from the use of Botox," she said. "Immunogenicity is an overstated problem. Use only [Food and Drug Administration]-approved toxins, even for off-label indications."

She concluded that Botox is "a great drug that we should have great respect for. So when we see reports of serious adverse events, let's find out if it is Botox or if it's something else that's being used in a nonapproved way. Remember that there is nearly 20 years of Botox safety in worldwide publications."

Dr. Carruthers disclosed that she has relevant relationships with a number of pharmaceutical and medical device companies, including Allergan Inc. and Bioform Medical Inc.

LAS VEGAS — Although Botox has enjoyed a top-notch safety and efficacy record for nearly 2 decades, a mouse study published in the Journal of Neuroscience piqued the interest of Dr. Jean D.A. Carruthers, who, with her husband, Dr. Alastair Carruthers, pioneered the cosmetic use of botulinum toxin type A.

For the study, Italian investigators injected a research neurotoxin into the rat whiskers and found that it cleaved SNAP-25 (synaptosomal-associated protein, 25 kDa) in the seventh cranial nerve nucleus (J. Neurosci. 2008;28:3689–96).

In two other experiments, hippocampal injection of the neurotoxin crossed to the opposite hippocampus, whereas tectal injection led to cleaved SNAP-25 in the opposite retina.

"This is fascinating, because it's never been shown before that neurotoxin can migrate toward the brain or away from the brain," Dr. Carruthers said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "However, they were using enormous doses compared with our human dosing; it's like a fire hose compared to a drip. [There haven't been] any human data to support this."

She did, however, note some published studies that demonstrated that a glabellar injection of Botox improves mood and helps people cope with their depression and anxiety, "so maybe there is something happening there. Maybe this opens up a new area for research. But in 25 years of clinical use, there haven't been studies that show there are intracranial abnormalities. There is something going on here that requires different analysis and more study."

In 2005 Dr. Carruthers, a Vancouver-based ophthalmologist and oculoplastic surgeon, and her husband, a dermatologist and dermatologic surgeon, performed a long-term safety study of 50 subjects after a minimum of 5 years since their initial Botox treatment. "They'd had at least 10 treatment sessions; these weren't novices," she said.

The mean age of the patients was 42 years, and 92% were female.

Of 851 treatment sessions, there were three cases of brow ptosis in two subjects, one case of eyelid ptosis, and one case of dysphagia. "All of the side effects were mild and transient," said Dr. Carruthers, also of the department of ophthalmology at the University of British Columbia, Vancouver, where she specializes in facial cosmetic surgery. "None of the patients were particularly concerned about the adverse events because they all settled down."

A systematic review and meta-analysis of 36 studies of 2,309 subjects yielded similar results (J. Curr. Med. Res. Opin. 2004;20:981–90). Mild to moderate adverse events occurred in 25% of the Botox-treated group, compared with 15% for placebo. Focal weakness was the only adverse event with significantly higher incidence in the Botox-treated group. No serious adverse events were reported.

Transient, local complications "are what we want to continue seeing from the use of Botox," she said. "Immunogenicity is an overstated problem. Use only [Food and Drug Administration]-approved toxins, even for off-label indications."

She concluded that Botox is "a great drug that we should have great respect for. So when we see reports of serious adverse events, let's find out if it is Botox or if it's something else that's being used in a nonapproved way. Remember that there is nearly 20 years of Botox safety in worldwide publications."

Dr. Carruthers disclosed that she has relevant relationships with a number of pharmaceutical and medical device companies, including Allergan Inc. and Bioform Medical Inc.

LAS VEGAS — Dr. Gary D. Monheit's ideal cosmetic neurotoxin would have a rapid time of onset and a stable pharmacologic action throughout its time of activity.

Its effect would also be limited to the muscle sites of injection. "There are many variables that we put into this formula, such as the dilution we give it, the force of injection, and our injection points," he said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "But we would like to have a toxin that stays stable where we're injecting it."

Other ideal properties include limited yet controlled diffusion or "the field of effect," few drug-related side effects such as pain or flulike symptoms, a natural-appearing response, and a prolonged action, "something greater than 6 months," he said.

At the present time no cosmetic neurotoxin meets all of these ideal properties, said Dr. Monheit of the departments of dermatology and ophthalmology at the University of Alabama at Birmingham. To date, Botox (Allergan Inc.) is the only cosmetic neurotoxin approved by the Food and Drug Administration, but Reloxin (known as Dysport in Europe and manufactured by Ipsen) is likely to enter the market this year.

It's difficult to directly compare Botox and Reloxin because the dosage units are registered differently (3:1 vs. 2.5:1, respectively), but Dr. Monheit maintained that the potency of the products "is essentially the same. The more units you put in of either, the more potent and the more the action is. But you have to look at each one of these [products] as a different drug. You can't truly convert back and forth because there is no direct scale to compare the units."

Because Botox is a heavier molecule than Reloxin (900 kd vs. 500–600 kd), some clinicians have presumed that Reloxin would tend to diffuse or migrate from the site of injection, leading to more adverse reactions than are seen with Botox. However, this presumption did not pan out in the phase III clinical studies of Reloxin.

"Diffusion is not relevant," commented Dr. Monheit, who was a clinical investigator for the Reloxin studies. "Spread or field of effect is dependent on dosage, dilution, and technical infection variables. Clinical data supports safety and efficacy at correct dosage and technique."

The phase III clinical trials of Reloxin demonstrated that the product's onset was in 2–3 days but occurred as soon as 24 hours for others. The average duration was 118 days.

Another neurotoxin in the pipeline is Xeomin, manufactured by Merz Pharmaceutical. One vial of the product contains botulinum neurotoxin type A free of complexing proteins, human serum albumin, and sucrose.

Xeomin is approved for use in Germany, and phase III clinical trials are currently underway in the United States. "Hearing Europeans who've used it, it seems very similar to Botox in its effect," said Dr. Monheit, who practices dermatology in Birmingham.

PurTox (Mentor Corp.) is also being investigated. This neurotoxin contains botulinum neurotoxin type A, yet it lacks the surrounding hemagglutinin protein complex. Phase II trials in the United States demonstrated that the end points of efficacy, safety, and longevity were similar to that seen with Botox for glabellar rhytides. "Its onset seems to be similar to Reloxin, while its activity is similar to Botox," Dr. Monheit said.

Phase III trials of PurTox in the United States began in July 2007.

Dr. Monheit reported that he is a consultant and clinical investigator for several pharmaceutical companies including Allergan, Ipsen, and Mentor Corp.

'There are many variables … but we would like to have a toxin that stays stable where we're injecting it.' DR. MONHEIT

LAS VEGAS — Dr. Gary D. Monheit's ideal cosmetic neurotoxin would have a rapid time of onset and a stable pharmacologic action throughout its time of activity.

Its effect would also be limited to the muscle sites of injection. "There are many variables that we put into this formula, such as the dilution we give it, the force of injection, and our injection points," he said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "But we would like to have a toxin that stays stable where we're injecting it."

Other ideal properties include limited yet controlled diffusion or "the field of effect," few drug-related side effects such as pain or flulike symptoms, a natural-appearing response, and a prolonged action, "something greater than 6 months," he said.

At the present time no cosmetic neurotoxin meets all of these ideal properties, said Dr. Monheit of the departments of dermatology and ophthalmology at the University of Alabama at Birmingham. To date, Botox (Allergan Inc.) is the only cosmetic neurotoxin approved by the Food and Drug Administration, but Reloxin (known as Dysport in Europe and manufactured by Ipsen) is likely to enter the market this year.

It's difficult to directly compare Botox and Reloxin because the dosage units are registered differently (3:1 vs. 2.5:1, respectively), but Dr. Monheit maintained that the potency of the products "is essentially the same. The more units you put in of either, the more potent and the more the action is. But you have to look at each one of these [products] as a different drug. You can't truly convert back and forth because there is no direct scale to compare the units."

Because Botox is a heavier molecule than Reloxin (900 kd vs. 500–600 kd), some clinicians have presumed that Reloxin would tend to diffuse or migrate from the site of injection, leading to more adverse reactions than are seen with Botox. However, this presumption did not pan out in the phase III clinical studies of Reloxin.

"Diffusion is not relevant," commented Dr. Monheit, who was a clinical investigator for the Reloxin studies. "Spread or field of effect is dependent on dosage, dilution, and technical infection variables. Clinical data supports safety and efficacy at correct dosage and technique."

The phase III clinical trials of Reloxin demonstrated that the product's onset was in 2–3 days but occurred as soon as 24 hours for others. The average duration was 118 days.

Another neurotoxin in the pipeline is Xeomin, manufactured by Merz Pharmaceutical. One vial of the product contains botulinum neurotoxin type A free of complexing proteins, human serum albumin, and sucrose.

Xeomin is approved for use in Germany, and phase III clinical trials are currently underway in the United States. "Hearing Europeans who've used it, it seems very similar to Botox in its effect," said Dr. Monheit, who practices dermatology in Birmingham.

PurTox (Mentor Corp.) is also being investigated. This neurotoxin contains botulinum neurotoxin type A, yet it lacks the surrounding hemagglutinin protein complex. Phase II trials in the United States demonstrated that the end points of efficacy, safety, and longevity were similar to that seen with Botox for glabellar rhytides. "Its onset seems to be similar to Reloxin, while its activity is similar to Botox," Dr. Monheit said.

Phase III trials of PurTox in the United States began in July 2007.

Dr. Monheit reported that he is a consultant and clinical investigator for several pharmaceutical companies including Allergan, Ipsen, and Mentor Corp.

'There are many variables … but we would like to have a toxin that stays stable where we're injecting it.' DR. MONHEIT

LAS VEGAS — Dr. Gary D. Monheit's ideal cosmetic neurotoxin would have a rapid time of onset and a stable pharmacologic action throughout its time of activity.

Its effect would also be limited to the muscle sites of injection. "There are many variables that we put into this formula, such as the dilution we give it, the force of injection, and our injection points," he said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "But we would like to have a toxin that stays stable where we're injecting it."

Other ideal properties include limited yet controlled diffusion or "the field of effect," few drug-related side effects such as pain or flulike symptoms, a natural-appearing response, and a prolonged action, "something greater than 6 months," he said.

At the present time no cosmetic neurotoxin meets all of these ideal properties, said Dr. Monheit of the departments of dermatology and ophthalmology at the University of Alabama at Birmingham. To date, Botox (Allergan Inc.) is the only cosmetic neurotoxin approved by the Food and Drug Administration, but Reloxin (known as Dysport in Europe and manufactured by Ipsen) is likely to enter the market this year.

It's difficult to directly compare Botox and Reloxin because the dosage units are registered differently (3:1 vs. 2.5:1, respectively), but Dr. Monheit maintained that the potency of the products "is essentially the same. The more units you put in of either, the more potent and the more the action is. But you have to look at each one of these [products] as a different drug. You can't truly convert back and forth because there is no direct scale to compare the units."

Because Botox is a heavier molecule than Reloxin (900 kd vs. 500–600 kd), some clinicians have presumed that Reloxin would tend to diffuse or migrate from the site of injection, leading to more adverse reactions than are seen with Botox. However, this presumption did not pan out in the phase III clinical studies of Reloxin.

"Diffusion is not relevant," commented Dr. Monheit, who was a clinical investigator for the Reloxin studies. "Spread or field of effect is dependent on dosage, dilution, and technical infection variables. Clinical data supports safety and efficacy at correct dosage and technique."

The phase III clinical trials of Reloxin demonstrated that the product's onset was in 2–3 days but occurred as soon as 24 hours for others. The average duration was 118 days.

Another neurotoxin in the pipeline is Xeomin, manufactured by Merz Pharmaceutical. One vial of the product contains botulinum neurotoxin type A free of complexing proteins, human serum albumin, and sucrose.

Xeomin is approved for use in Germany, and phase III clinical trials are currently underway in the United States. "Hearing Europeans who've used it, it seems very similar to Botox in its effect," said Dr. Monheit, who practices dermatology in Birmingham.

PurTox (Mentor Corp.) is also being investigated. This neurotoxin contains botulinum neurotoxin type A, yet it lacks the surrounding hemagglutinin protein complex. Phase II trials in the United States demonstrated that the end points of efficacy, safety, and longevity were similar to that seen with Botox for glabellar rhytides. "Its onset seems to be similar to Reloxin, while its activity is similar to Botox," Dr. Monheit said.

Phase III trials of PurTox in the United States began in July 2007.

Dr. Monheit reported that he is a consultant and clinical investigator for several pharmaceutical companies including Allergan, Ipsen, and Mentor Corp.

'There are many variables … but we would like to have a toxin that stays stable where we're injecting it.' DR. MONHEIT

LAS VEGAS — Before investing in a laser, take patient demographics into consideration, suggested Dr. Arielle N.B. Kauvar.

For example, for practices with a large number of patients with acne and rosacea, intense pulsed light (IPL) devices, pulsed dye lasers, or potassium-titanyl-phosphate (KTP) lasers would be good choices. "With all three of these, you can also treat pigmented lesions, so you'd have some versatility," Dr. Kauvar said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery.

IPL also can be used for hair removal, but for rosacea patients it may require more treatment sessions for individuals with discrete telangiectasia, said Dr. Kauvar, a dermatologist who practices in New York. Pulsed dye lasers also can be used to treat vascular birthmarks and hypertrophic scars.

For practices with a large number of patients asking for tattoo removal as well as rejuvenation, she recommends Q-switched lasers plus another device. "To effectively treat tattoos, you need three wavelengths," she said. "So you need to have one device that has all three wavelengths or you have to purchase two different lasers. Then you'll need a separate device for rejuvenation."

After a device has been selected, the new procedures will have to be accommodated into the work flow. If you currently have a busy medical dermatology practice, "you need to think about scheduling these patients at a different time," Dr. Kauvar said. "If you are already performing some type of cosmetic procedure such as injectables, liposuction, or sclerotherapy, you are at a distinct advantage because most patients seeking one cosmetic procedure will be interested in others as well."

She discussed other points to consider before purchasing a laser:

▸ Recognize patient needs. To determine what devices would be most appropriate, consider asking patients to fill out an office questionnaire to get a sense of treatments that interest them. Provide them with a list of common treatments "because they may not know that their problem is treatable," she noted. "Ask them to prioritize their list, and get some idea of what they would be willing to pay for a procedure or for a series of treatments."

When the day comes to add a new procedure, discount the initial treatments. This "allows you to develop experience with the procedure and it also provides you with feedback from your patients," she said.

▸ Set a monthly budget. Individual devices can cost up to $150,000. Most clinicians lease their equipment for 3–5 years, but month-to-month rental is another option. "You need to figure out how many procedures you have to perform to break even with each device that you add to your practice," Dr. Kauvar advised.

Renting a laser provides an opportunity to try it without a long-term commitment, but the rental costs are steep—usually $1,000/day per laser.

On the other hand, a 3-year lease on a $100,000 laser would cost about $3,000/month, while a 2-year lease on that same unit would cost about $2,000/month. "This monthly lease amount will vary to some degree depending on your termination options," she said. Leasing may provide a tax advantage in the form of depreciation of the equipment, but it also poses certain disadvantages, including a long-term financial commitment and the fact that technology evolves quickly.

Other costs to consider before buying a laser include maintenance contracts, which are "almost always advisable," said Dr. Kauvar, also of the department of dermatology at New York University. "Typically they come with 1- to 3-year warranties. But once the warranty expires, you will probably have to pay somewhere on the order of $5,000–$10,000/laser per year for a maintenance contract. You have to factor that into the cost of the device."

Maintenance contracts are important, "because these are fragile pieces of equipment, and they do break down."

Other hidden costs include items such as laser or device tips, replacement heads for IPL devices, cryogen, marketing materials in the form of brochures and advertisements, and possible installation of a dedicated high-voltage line. "You also need to assess your ventilation needs, because many of these lasers and devices generate a lot of heat output," she noted.

▸ Get training. Seek out appropriate training in laser safety and laser-tissue interactions, "not only didactic training sessions but hands-on laser training sessions for techniques and procedures," Dr. Kauvar said. "You have to absolutely understand what you're doing to the skin."

She also warned against delegating these procedures to untrained staff. "They're not cookbook procedures," she said. "When these lasers and devices are used inappropriately, they can lead to long-term dyspigmentation and scarring."

Dr. Kauvar disclosed having no relevant conflicts of interest.

LAS VEGAS — Before investing in a laser, take patient demographics into consideration, suggested Dr. Arielle N.B. Kauvar.

For example, for practices with a large number of patients with acne and rosacea, intense pulsed light (IPL) devices, pulsed dye lasers, or potassium-titanyl-phosphate (KTP) lasers would be good choices. "With all three of these, you can also treat pigmented lesions, so you'd have some versatility," Dr. Kauvar said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery.

IPL also can be used for hair removal, but for rosacea patients it may require more treatment sessions for individuals with discrete telangiectasia, said Dr. Kauvar, a dermatologist who practices in New York. Pulsed dye lasers also can be used to treat vascular birthmarks and hypertrophic scars.

For practices with a large number of patients asking for tattoo removal as well as rejuvenation, she recommends Q-switched lasers plus another device. "To effectively treat tattoos, you need three wavelengths," she said. "So you need to have one device that has all three wavelengths or you have to purchase two different lasers. Then you'll need a separate device for rejuvenation."

After a device has been selected, the new procedures will have to be accommodated into the work flow. If you currently have a busy medical dermatology practice, "you need to think about scheduling these patients at a different time," Dr. Kauvar said. "If you are already performing some type of cosmetic procedure such as injectables, liposuction, or sclerotherapy, you are at a distinct advantage because most patients seeking one cosmetic procedure will be interested in others as well."

She discussed other points to consider before purchasing a laser:

▸ Recognize patient needs. To determine what devices would be most appropriate, consider asking patients to fill out an office questionnaire to get a sense of treatments that interest them. Provide them with a list of common treatments "because they may not know that their problem is treatable," she noted. "Ask them to prioritize their list, and get some idea of what they would be willing to pay for a procedure or for a series of treatments."

When the day comes to add a new procedure, discount the initial treatments. This "allows you to develop experience with the procedure and it also provides you with feedback from your patients," she said.

▸ Set a monthly budget. Individual devices can cost up to $150,000. Most clinicians lease their equipment for 3–5 years, but month-to-month rental is another option. "You need to figure out how many procedures you have to perform to break even with each device that you add to your practice," Dr. Kauvar advised.

Renting a laser provides an opportunity to try it without a long-term commitment, but the rental costs are steep—usually $1,000/day per laser.

On the other hand, a 3-year lease on a $100,000 laser would cost about $3,000/month, while a 2-year lease on that same unit would cost about $2,000/month. "This monthly lease amount will vary to some degree depending on your termination options," she said. Leasing may provide a tax advantage in the form of depreciation of the equipment, but it also poses certain disadvantages, including a long-term financial commitment and the fact that technology evolves quickly.

Other costs to consider before buying a laser include maintenance contracts, which are "almost always advisable," said Dr. Kauvar, also of the department of dermatology at New York University. "Typically they come with 1- to 3-year warranties. But once the warranty expires, you will probably have to pay somewhere on the order of $5,000–$10,000/laser per year for a maintenance contract. You have to factor that into the cost of the device."

Maintenance contracts are important, "because these are fragile pieces of equipment, and they do break down."

Other hidden costs include items such as laser or device tips, replacement heads for IPL devices, cryogen, marketing materials in the form of brochures and advertisements, and possible installation of a dedicated high-voltage line. "You also need to assess your ventilation needs, because many of these lasers and devices generate a lot of heat output," she noted.

▸ Get training. Seek out appropriate training in laser safety and laser-tissue interactions, "not only didactic training sessions but hands-on laser training sessions for techniques and procedures," Dr. Kauvar said. "You have to absolutely understand what you're doing to the skin."

She also warned against delegating these procedures to untrained staff. "They're not cookbook procedures," she said. "When these lasers and devices are used inappropriately, they can lead to long-term dyspigmentation and scarring."

Dr. Kauvar disclosed having no relevant conflicts of interest.

LAS VEGAS — Before investing in a laser, take patient demographics into consideration, suggested Dr. Arielle N.B. Kauvar.

For example, for practices with a large number of patients with acne and rosacea, intense pulsed light (IPL) devices, pulsed dye lasers, or potassium-titanyl-phosphate (KTP) lasers would be good choices. "With all three of these, you can also treat pigmented lesions, so you'd have some versatility," Dr. Kauvar said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery.

IPL also can be used for hair removal, but for rosacea patients it may require more treatment sessions for individuals with discrete telangiectasia, said Dr. Kauvar, a dermatologist who practices in New York. Pulsed dye lasers also can be used to treat vascular birthmarks and hypertrophic scars.

For practices with a large number of patients asking for tattoo removal as well as rejuvenation, she recommends Q-switched lasers plus another device. "To effectively treat tattoos, you need three wavelengths," she said. "So you need to have one device that has all three wavelengths or you have to purchase two different lasers. Then you'll need a separate device for rejuvenation."

After a device has been selected, the new procedures will have to be accommodated into the work flow. If you currently have a busy medical dermatology practice, "you need to think about scheduling these patients at a different time," Dr. Kauvar said. "If you are already performing some type of cosmetic procedure such as injectables, liposuction, or sclerotherapy, you are at a distinct advantage because most patients seeking one cosmetic procedure will be interested in others as well."

She discussed other points to consider before purchasing a laser:

▸ Recognize patient needs. To determine what devices would be most appropriate, consider asking patients to fill out an office questionnaire to get a sense of treatments that interest them. Provide them with a list of common treatments "because they may not know that their problem is treatable," she noted. "Ask them to prioritize their list, and get some idea of what they would be willing to pay for a procedure or for a series of treatments."

When the day comes to add a new procedure, discount the initial treatments. This "allows you to develop experience with the procedure and it also provides you with feedback from your patients," she said.

▸ Set a monthly budget. Individual devices can cost up to $150,000. Most clinicians lease their equipment for 3–5 years, but month-to-month rental is another option. "You need to figure out how many procedures you have to perform to break even with each device that you add to your practice," Dr. Kauvar advised.

Renting a laser provides an opportunity to try it without a long-term commitment, but the rental costs are steep—usually $1,000/day per laser.

On the other hand, a 3-year lease on a $100,000 laser would cost about $3,000/month, while a 2-year lease on that same unit would cost about $2,000/month. "This monthly lease amount will vary to some degree depending on your termination options," she said. Leasing may provide a tax advantage in the form of depreciation of the equipment, but it also poses certain disadvantages, including a long-term financial commitment and the fact that technology evolves quickly.

Other costs to consider before buying a laser include maintenance contracts, which are "almost always advisable," said Dr. Kauvar, also of the department of dermatology at New York University. "Typically they come with 1- to 3-year warranties. But once the warranty expires, you will probably have to pay somewhere on the order of $5,000–$10,000/laser per year for a maintenance contract. You have to factor that into the cost of the device."

Maintenance contracts are important, "because these are fragile pieces of equipment, and they do break down."

Other hidden costs include items such as laser or device tips, replacement heads for IPL devices, cryogen, marketing materials in the form of brochures and advertisements, and possible installation of a dedicated high-voltage line. "You also need to assess your ventilation needs, because many of these lasers and devices generate a lot of heat output," she noted.

▸ Get training. Seek out appropriate training in laser safety and laser-tissue interactions, "not only didactic training sessions but hands-on laser training sessions for techniques and procedures," Dr. Kauvar said. "You have to absolutely understand what you're doing to the skin."

She also warned against delegating these procedures to untrained staff. "They're not cookbook procedures," she said. "When these lasers and devices are used inappropriately, they can lead to long-term dyspigmentation and scarring."

Dr. Kauvar disclosed having no relevant conflicts of interest.

LAS VEGAS — The hysterectomy rate was less than 10% among 711 women who underwent global endometrial ablation, results from a long-term, single-center study showed.

Hematometra was present in 25% of the 44 women who had a hysterectomy because of pain and in 2% of the 25 women who had a hysterectomy because of bleeding. This marked the only significant difference between the two groups, according to Dr. Erin Carey, who called these the key findings from what is believed to be the largest study aimed at capturing the clinical and pathological characteristics of women who had a hysterectomy after global endometrial ablation (GEA).

“We know that women who are younger than 45 are more likely to fail global endometrial ablation, as well as women with a history of bilateral tubal ligation and those with a history of preoperative dysmenorrhea,” said Dr. Carey of the department of obstetrics and gynecology at the Mayo Clinic, Rochester, Minn. Other contributing clinical and pathological factors remain unclear. She reported the study findings at the annual meeting of the AAGL.

Dr. Carey and associates identified 711 women who underwent GEA for menorrhagia between January 1998 and December 2005. They compared data between women who underwent hysterectomy and those who did not during the follow-up period, which lasted a mean of 2.9 years.

Adenomyosis was present in 29% of women who had a hysterectomy for pain and in 28% who had a hysterectomy for bleeding. “Adenomyosis has been thought to be a major factor related to postablation pain syndrome,” Dr. Carey commented. “However, we found that women had a lower rate of adenomyosis than we expected, and the rates were similar in both groups.”

Dr. Carey had no disclosures to make.

LAS VEGAS — The hysterectomy rate was less than 10% among 711 women who underwent global endometrial ablation, results from a long-term, single-center study showed.

Hematometra was present in 25% of the 44 women who had a hysterectomy because of pain and in 2% of the 25 women who had a hysterectomy because of bleeding. This marked the only significant difference between the two groups, according to Dr. Erin Carey, who called these the key findings from what is believed to be the largest study aimed at capturing the clinical and pathological characteristics of women who had a hysterectomy after global endometrial ablation (GEA).

“We know that women who are younger than 45 are more likely to fail global endometrial ablation, as well as women with a history of bilateral tubal ligation and those with a history of preoperative dysmenorrhea,” said Dr. Carey of the department of obstetrics and gynecology at the Mayo Clinic, Rochester, Minn. Other contributing clinical and pathological factors remain unclear. She reported the study findings at the annual meeting of the AAGL.

Dr. Carey and associates identified 711 women who underwent GEA for menorrhagia between January 1998 and December 2005. They compared data between women who underwent hysterectomy and those who did not during the follow-up period, which lasted a mean of 2.9 years.

Adenomyosis was present in 29% of women who had a hysterectomy for pain and in 28% who had a hysterectomy for bleeding. “Adenomyosis has been thought to be a major factor related to postablation pain syndrome,” Dr. Carey commented. “However, we found that women had a lower rate of adenomyosis than we expected, and the rates were similar in both groups.”

Dr. Carey had no disclosures to make.

LAS VEGAS — The hysterectomy rate was less than 10% among 711 women who underwent global endometrial ablation, results from a long-term, single-center study showed.

Hematometra was present in 25% of the 44 women who had a hysterectomy because of pain and in 2% of the 25 women who had a hysterectomy because of bleeding. This marked the only significant difference between the two groups, according to Dr. Erin Carey, who called these the key findings from what is believed to be the largest study aimed at capturing the clinical and pathological characteristics of women who had a hysterectomy after global endometrial ablation (GEA).

“We know that women who are younger than 45 are more likely to fail global endometrial ablation, as well as women with a history of bilateral tubal ligation and those with a history of preoperative dysmenorrhea,” said Dr. Carey of the department of obstetrics and gynecology at the Mayo Clinic, Rochester, Minn. Other contributing clinical and pathological factors remain unclear. She reported the study findings at the annual meeting of the AAGL.

Dr. Carey and associates identified 711 women who underwent GEA for menorrhagia between January 1998 and December 2005. They compared data between women who underwent hysterectomy and those who did not during the follow-up period, which lasted a mean of 2.9 years.

Adenomyosis was present in 29% of women who had a hysterectomy for pain and in 28% who had a hysterectomy for bleeding. “Adenomyosis has been thought to be a major factor related to postablation pain syndrome,” Dr. Carey commented. “However, we found that women had a lower rate of adenomyosis than we expected, and the rates were similar in both groups.”

Dr. Carey had no disclosures to make.

SAN DIEGO — Treatment of mild gestational diabetes did not reduce the frequency of several commonly reported morbidities associated with diabetic pregnancy, results from a large multicenter randomized trial demonstrated.

However, treatment did lower birth weight and resulted in a 50% reduction in macrosomia, as well as lower neonatal fat mass, rates of shoulder dystocia, cesarean delivery, preeclampsia, and gestational hypertension.

“Identification and treatment of mild gestational diabetes is clearly associated with significant clinical benefits,” principal investigator Dr. Mark B. Landon said at the annual meeting of the Society for Maternal-Fetal Medicine.

The incidence of gestational diabetes, defined as glucose intolerance with onset or first recognition during pregnancy, is rising in the United States, said Dr. Landon, professor of obstetrics and gynecology at the Ohio State University, Columbus.

More than 45 years ago researchers “first proposed criteria for the diagnosis, which were based on the subsequent development of adult onset diabetes and not on any association between carbohydrate intolerance and adverse pregnancy outcomes,” he said. “Thus, the clinical significance of gestational diabetes and, in particular, mild gestational diabetes as it relates to perinatal morbidity is unclear and has been challenged for decades.”

He went on to note that, based largely on results of retrospective single-center studies to date, there has been “widespread acceptance of screening and treatment of gestational diabetes by professional organizations with little evidence of demonstrable benefit.”

However, in 2003 and in 2008 the U.S. Preventive Services Task Force issued statements concluding that there is insufficient evidence to determine if a health benefit to the treatment of mild gestational diabetes exists.

The controversy prompted the maternal-fetal medicine units network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development to conduct a randomized trial to determine if treatment of mild gestational diabetes reduced perinatal morbidity.

For the study, 958 women with a singleton gestation and who met criteria for mild gestational diabetes (defined as a fasting value of less than 95 mg/dL on a blinded 3-hour oral glucose tolerance test) were allocated to one of two groups.

The 485 women in the treatment group received formal nutrition counseling, instruction on self-monitoring of blood glucose, and insulin administration, if necessary.

The 473 women in the control group received standard routine obstetric care, and clinicians and study participants were unaware of their glucose tolerance test results.

The primary end point was a composite outcome that consisted of perinatal mortality; neonatal hypoglycemia defined as a value less than 35 mg/dL during the first 2 hours of life without feeding; a serum bilirubin greater than 8 mg/dL between 16 and 36 hours of life, hyperinsulinemia as reflected by a cord blood C-peptide greater than the 95th percentile, or birth trauma.

Dr. Landon reported that the average age of the study participants was 29 years.

There were no differences between the groups in the frequency of composite primary neonatal outcome (32% in the treatment group vs. 37% in the control group).

Among secondary outcomes, the researchers observed a significant difference between the treatment and control groups in terms of mean birth weight (3,302 g vs. 3,408 g, respectively), fetal fat mass (427 g vs. 464 g), and the frequency of infants weighing greater than 4,000 g at birth (6% vs. 14%).

There were no differences between the two groups in terms of NICU admission, preterm delivery, respiratory distress syndrome, or need for intravenous glucose treatment.

As for maternal outcomes, induction of labor rates were similar between the two groups (about 27%), but women in the treatment group had significantly lower overall rates of cesarean delivery (27% vs. 34%) and rates of cesarean corrected for abnormal presentation and prior cesarean (13% vs. 20%).

The rate of shoulder dystocia also was reduced with treatment (2% vs. 4%) as was the rate of preeclampsia and gestational hypertension as a composite (9% vs. 14%).

Dr. Landon concluded that the study findings “should complement the ongoing analysis of the recent Hyperglycemia and Adverse Pregnancy Outcome study as experts develop a consensus for the diagnosis and treatment of carbohydrate intolerance during pregnancy.”

Dr. Landon had no conflicts to disclose.

The rate of preeclampsia and gestational hypertension as a composite was reduced with treatment. DR. LANDON

SAN DIEGO — Treatment of mild gestational diabetes did not reduce the frequency of several commonly reported morbidities associated with diabetic pregnancy, results from a large multicenter randomized trial demonstrated.

However, treatment did lower birth weight and resulted in a 50% reduction in macrosomia, as well as lower neonatal fat mass, rates of shoulder dystocia, cesarean delivery, preeclampsia, and gestational hypertension.

“Identification and treatment of mild gestational diabetes is clearly associated with significant clinical benefits,” principal investigator Dr. Mark B. Landon said at the annual meeting of the Society for Maternal-Fetal Medicine.

The incidence of gestational diabetes, defined as glucose intolerance with onset or first recognition during pregnancy, is rising in the United States, said Dr. Landon, professor of obstetrics and gynecology at the Ohio State University, Columbus.

More than 45 years ago researchers “first proposed criteria for the diagnosis, which were based on the subsequent development of adult onset diabetes and not on any association between carbohydrate intolerance and adverse pregnancy outcomes,” he said. “Thus, the clinical significance of gestational diabetes and, in particular, mild gestational diabetes as it relates to perinatal morbidity is unclear and has been challenged for decades.”

He went on to note that, based largely on results of retrospective single-center studies to date, there has been “widespread acceptance of screening and treatment of gestational diabetes by professional organizations with little evidence of demonstrable benefit.”

However, in 2003 and in 2008 the U.S. Preventive Services Task Force issued statements concluding that there is insufficient evidence to determine if a health benefit to the treatment of mild gestational diabetes exists.

The controversy prompted the maternal-fetal medicine units network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development to conduct a randomized trial to determine if treatment of mild gestational diabetes reduced perinatal morbidity.

For the study, 958 women with a singleton gestation and who met criteria for mild gestational diabetes (defined as a fasting value of less than 95 mg/dL on a blinded 3-hour oral glucose tolerance test) were allocated to one of two groups.

The 485 women in the treatment group received formal nutrition counseling, instruction on self-monitoring of blood glucose, and insulin administration, if necessary.

The 473 women in the control group received standard routine obstetric care, and clinicians and study participants were unaware of their glucose tolerance test results.

The primary end point was a composite outcome that consisted of perinatal mortality; neonatal hypoglycemia defined as a value less than 35 mg/dL during the first 2 hours of life without feeding; a serum bilirubin greater than 8 mg/dL between 16 and 36 hours of life, hyperinsulinemia as reflected by a cord blood C-peptide greater than the 95th percentile, or birth trauma.

Dr. Landon reported that the average age of the study participants was 29 years.

There were no differences between the groups in the frequency of composite primary neonatal outcome (32% in the treatment group vs. 37% in the control group).

Among secondary outcomes, the researchers observed a significant difference between the treatment and control groups in terms of mean birth weight (3,302 g vs. 3,408 g, respectively), fetal fat mass (427 g vs. 464 g), and the frequency of infants weighing greater than 4,000 g at birth (6% vs. 14%).

There were no differences between the two groups in terms of NICU admission, preterm delivery, respiratory distress syndrome, or need for intravenous glucose treatment.

As for maternal outcomes, induction of labor rates were similar between the two groups (about 27%), but women in the treatment group had significantly lower overall rates of cesarean delivery (27% vs. 34%) and rates of cesarean corrected for abnormal presentation and prior cesarean (13% vs. 20%).

The rate of shoulder dystocia also was reduced with treatment (2% vs. 4%) as was the rate of preeclampsia and gestational hypertension as a composite (9% vs. 14%).

Dr. Landon concluded that the study findings “should complement the ongoing analysis of the recent Hyperglycemia and Adverse Pregnancy Outcome study as experts develop a consensus for the diagnosis and treatment of carbohydrate intolerance during pregnancy.”

Dr. Landon had no conflicts to disclose.

The rate of preeclampsia and gestational hypertension as a composite was reduced with treatment. DR. LANDON

SAN DIEGO — Treatment of mild gestational diabetes did not reduce the frequency of several commonly reported morbidities associated with diabetic pregnancy, results from a large multicenter randomized trial demonstrated.

However, treatment did lower birth weight and resulted in a 50% reduction in macrosomia, as well as lower neonatal fat mass, rates of shoulder dystocia, cesarean delivery, preeclampsia, and gestational hypertension.

“Identification and treatment of mild gestational diabetes is clearly associated with significant clinical benefits,” principal investigator Dr. Mark B. Landon said at the annual meeting of the Society for Maternal-Fetal Medicine.

The incidence of gestational diabetes, defined as glucose intolerance with onset or first recognition during pregnancy, is rising in the United States, said Dr. Landon, professor of obstetrics and gynecology at the Ohio State University, Columbus.

More than 45 years ago researchers “first proposed criteria for the diagnosis, which were based on the subsequent development of adult onset diabetes and not on any association between carbohydrate intolerance and adverse pregnancy outcomes,” he said. “Thus, the clinical significance of gestational diabetes and, in particular, mild gestational diabetes as it relates to perinatal morbidity is unclear and has been challenged for decades.”

He went on to note that, based largely on results of retrospective single-center studies to date, there has been “widespread acceptance of screening and treatment of gestational diabetes by professional organizations with little evidence of demonstrable benefit.”

However, in 2003 and in 2008 the U.S. Preventive Services Task Force issued statements concluding that there is insufficient evidence to determine if a health benefit to the treatment of mild gestational diabetes exists.

The controversy prompted the maternal-fetal medicine units network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development to conduct a randomized trial to determine if treatment of mild gestational diabetes reduced perinatal morbidity.

For the study, 958 women with a singleton gestation and who met criteria for mild gestational diabetes (defined as a fasting value of less than 95 mg/dL on a blinded 3-hour oral glucose tolerance test) were allocated to one of two groups.

The 485 women in the treatment group received formal nutrition counseling, instruction on self-monitoring of blood glucose, and insulin administration, if necessary.

The 473 women in the control group received standard routine obstetric care, and clinicians and study participants were unaware of their glucose tolerance test results.

The primary end point was a composite outcome that consisted of perinatal mortality; neonatal hypoglycemia defined as a value less than 35 mg/dL during the first 2 hours of life without feeding; a serum bilirubin greater than 8 mg/dL between 16 and 36 hours of life, hyperinsulinemia as reflected by a cord blood C-peptide greater than the 95th percentile, or birth trauma.

Dr. Landon reported that the average age of the study participants was 29 years.

There were no differences between the groups in the frequency of composite primary neonatal outcome (32% in the treatment group vs. 37% in the control group).

Among secondary outcomes, the researchers observed a significant difference between the treatment and control groups in terms of mean birth weight (3,302 g vs. 3,408 g, respectively), fetal fat mass (427 g vs. 464 g), and the frequency of infants weighing greater than 4,000 g at birth (6% vs. 14%).

There were no differences between the two groups in terms of NICU admission, preterm delivery, respiratory distress syndrome, or need for intravenous glucose treatment.

As for maternal outcomes, induction of labor rates were similar between the two groups (about 27%), but women in the treatment group had significantly lower overall rates of cesarean delivery (27% vs. 34%) and rates of cesarean corrected for abnormal presentation and prior cesarean (13% vs. 20%).

The rate of shoulder dystocia also was reduced with treatment (2% vs. 4%) as was the rate of preeclampsia and gestational hypertension as a composite (9% vs. 14%).

Dr. Landon concluded that the study findings “should complement the ongoing analysis of the recent Hyperglycemia and Adverse Pregnancy Outcome study as experts develop a consensus for the diagnosis and treatment of carbohydrate intolerance during pregnancy.”

Dr. Landon had no conflicts to disclose.

The rate of preeclampsia and gestational hypertension as a composite was reduced with treatment. DR. LANDON

The 300-index of reactivity dose of 5-grass-pollen sublingual immunotherapy tablets resulted in a significant improvement in the rhinoconjunctivitis total symptom score in children and adolescents with pollen-related allergic rhinitis, results from a European multicenter study demonstrated.

A recent study of adults determined that the 300-index of reactivity tablet is the optimal dose of a 5-grass-pollen sublingual immunotherapy tablet (SLIT) for treating grass pollen-related rhinitis over the first pollen season (J. Allergy Clin. Immunol. 2007;120:1338–45). The current study, however, demonstrates that the identical dose is safe and effective in a pediatric population with a precoseasonal regimen starting 4 months before the expected start of the pollen season and continued throughout the season.

The tablets are not marketed in the United States.

“This study demonstrates first-season efficacy in children and adolescents given preseasonal and coseasonal specific immunotherapy, but this needs to be assessed in a long-term, placebo-controlled trial over several years,” researchers led by Dr. Ulrich Wahn of Charité Hospital in Munich reported.

“Further studies are also needed to identify the optimal maintenance dose, and longer-term data are required to confirm whether SLIT will prevent progression from allergic rhinitis to asthma.”

For the randomized, double-blind, placebo-controlled study, the researchers enrolled 278 children and adolescents aged 5–17 years at 29 centers in France, Spain, Germany, Poland, and Denmark. Each had grass pollen-related rhinoconjunctivitis for at least 2 years, as confirmed by a positive skin prick test and a timothy grass pollen-specific IgE level of at least class 2.

Of the 278 patients, 139 received once-daily SLIT tablets manufactured by Stallergenes of Antony, France, and 139 received placebo (J. Allergy Clin. Immunol. 2009;123:160–6). Treatment began 4 months prior to the estimated pollen season and continued throughout the season. The primary outcome measure was the rhinoconjunctivitis total symptom score (RTSS), which includes the six most common symptoms of pollinosis (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus, and watery eyes).

The researchers reported that the mean treatment duration before pollen season was 113 days, while the mean treatment duration during pollen season was 39 days. Over that period, children in the treatment group experienced a statistically significant reduction in total rhinoconjunctivitis symptoms, as measured by the RTSS. Specifically, the improvement was 28% greater than that observed in the placebo group, for a median improvement of 39% during the pollen season.

“The level of improvement of mean RTSS compared with placebo exceeded the 20% threshold, which is suggested as the threshold for clinically relevant efficacy,” the researchers noted. “This magnitude of effect is similar to that found in recent studies using SLIT tables in adult populations and occurred despite the use of rescue medication.”

The mean rescue medication score was significantly reduced in the treatment group, compared with the placebo group, for a median reduction of 49% during the pollen season.

Two patients in the treatment group and three patients in the placebo group had exacerbation of asthma, but none of the episodes was thought to be related to the study treatment.

The researchers pointed out that children allergic only to grass pollens (monosensitized), as well as those sensitive to grass pollens plus other allergens (polysensitized), were studied. Both groups showed evidence of comparable improvement.

The study was supported by Stallergenes. One of the study's seven authors disclosed that she has served as a consultant for and received research support from Stallergenes. Another disclosed that she has received honoraria and research support from the company.

The 300-index of reactivity dose of 5-grass-pollen sublingual immunotherapy tablets resulted in a significant improvement in the rhinoconjunctivitis total symptom score in children and adolescents with pollen-related allergic rhinitis, results from a European multicenter study demonstrated.

A recent study of adults determined that the 300-index of reactivity tablet is the optimal dose of a 5-grass-pollen sublingual immunotherapy tablet (SLIT) for treating grass pollen-related rhinitis over the first pollen season (J. Allergy Clin. Immunol. 2007;120:1338–45). The current study, however, demonstrates that the identical dose is safe and effective in a pediatric population with a precoseasonal regimen starting 4 months before the expected start of the pollen season and continued throughout the season.

The tablets are not marketed in the United States.

“This study demonstrates first-season efficacy in children and adolescents given preseasonal and coseasonal specific immunotherapy, but this needs to be assessed in a long-term, placebo-controlled trial over several years,” researchers led by Dr. Ulrich Wahn of Charité Hospital in Munich reported.

“Further studies are also needed to identify the optimal maintenance dose, and longer-term data are required to confirm whether SLIT will prevent progression from allergic rhinitis to asthma.”

For the randomized, double-blind, placebo-controlled study, the researchers enrolled 278 children and adolescents aged 5–17 years at 29 centers in France, Spain, Germany, Poland, and Denmark. Each had grass pollen-related rhinoconjunctivitis for at least 2 years, as confirmed by a positive skin prick test and a timothy grass pollen-specific IgE level of at least class 2.

Of the 278 patients, 139 received once-daily SLIT tablets manufactured by Stallergenes of Antony, France, and 139 received placebo (J. Allergy Clin. Immunol. 2009;123:160–6). Treatment began 4 months prior to the estimated pollen season and continued throughout the season. The primary outcome measure was the rhinoconjunctivitis total symptom score (RTSS), which includes the six most common symptoms of pollinosis (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus, and watery eyes).

The researchers reported that the mean treatment duration before pollen season was 113 days, while the mean treatment duration during pollen season was 39 days. Over that period, children in the treatment group experienced a statistically significant reduction in total rhinoconjunctivitis symptoms, as measured by the RTSS. Specifically, the improvement was 28% greater than that observed in the placebo group, for a median improvement of 39% during the pollen season.

“The level of improvement of mean RTSS compared with placebo exceeded the 20% threshold, which is suggested as the threshold for clinically relevant efficacy,” the researchers noted. “This magnitude of effect is similar to that found in recent studies using SLIT tables in adult populations and occurred despite the use of rescue medication.”

The mean rescue medication score was significantly reduced in the treatment group, compared with the placebo group, for a median reduction of 49% during the pollen season.

Two patients in the treatment group and three patients in the placebo group had exacerbation of asthma, but none of the episodes was thought to be related to the study treatment.

The researchers pointed out that children allergic only to grass pollens (monosensitized), as well as those sensitive to grass pollens plus other allergens (polysensitized), were studied. Both groups showed evidence of comparable improvement.

The study was supported by Stallergenes. One of the study's seven authors disclosed that she has served as a consultant for and received research support from Stallergenes. Another disclosed that she has received honoraria and research support from the company.

The 300-index of reactivity dose of 5-grass-pollen sublingual immunotherapy tablets resulted in a significant improvement in the rhinoconjunctivitis total symptom score in children and adolescents with pollen-related allergic rhinitis, results from a European multicenter study demonstrated.

A recent study of adults determined that the 300-index of reactivity tablet is the optimal dose of a 5-grass-pollen sublingual immunotherapy tablet (SLIT) for treating grass pollen-related rhinitis over the first pollen season (J. Allergy Clin. Immunol. 2007;120:1338–45). The current study, however, demonstrates that the identical dose is safe and effective in a pediatric population with a precoseasonal regimen starting 4 months before the expected start of the pollen season and continued throughout the season.

The tablets are not marketed in the United States.

“This study demonstrates first-season efficacy in children and adolescents given preseasonal and coseasonal specific immunotherapy, but this needs to be assessed in a long-term, placebo-controlled trial over several years,” researchers led by Dr. Ulrich Wahn of Charité Hospital in Munich reported.

“Further studies are also needed to identify the optimal maintenance dose, and longer-term data are required to confirm whether SLIT will prevent progression from allergic rhinitis to asthma.”

For the randomized, double-blind, placebo-controlled study, the researchers enrolled 278 children and adolescents aged 5–17 years at 29 centers in France, Spain, Germany, Poland, and Denmark. Each had grass pollen-related rhinoconjunctivitis for at least 2 years, as confirmed by a positive skin prick test and a timothy grass pollen-specific IgE level of at least class 2.

Of the 278 patients, 139 received once-daily SLIT tablets manufactured by Stallergenes of Antony, France, and 139 received placebo (J. Allergy Clin. Immunol. 2009;123:160–6). Treatment began 4 months prior to the estimated pollen season and continued throughout the season. The primary outcome measure was the rhinoconjunctivitis total symptom score (RTSS), which includes the six most common symptoms of pollinosis (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus, and watery eyes).

The researchers reported that the mean treatment duration before pollen season was 113 days, while the mean treatment duration during pollen season was 39 days. Over that period, children in the treatment group experienced a statistically significant reduction in total rhinoconjunctivitis symptoms, as measured by the RTSS. Specifically, the improvement was 28% greater than that observed in the placebo group, for a median improvement of 39% during the pollen season.

“The level of improvement of mean RTSS compared with placebo exceeded the 20% threshold, which is suggested as the threshold for clinically relevant efficacy,” the researchers noted. “This magnitude of effect is similar to that found in recent studies using SLIT tables in adult populations and occurred despite the use of rescue medication.”

The mean rescue medication score was significantly reduced in the treatment group, compared with the placebo group, for a median reduction of 49% during the pollen season.

Two patients in the treatment group and three patients in the placebo group had exacerbation of asthma, but none of the episodes was thought to be related to the study treatment.

The researchers pointed out that children allergic only to grass pollens (monosensitized), as well as those sensitive to grass pollens plus other allergens (polysensitized), were studied. Both groups showed evidence of comparable improvement.

The study was supported by Stallergenes. One of the study's seven authors disclosed that she has served as a consultant for and received research support from Stallergenes. Another disclosed that she has received honoraria and research support from the company.

SAN DIEGO — Treatment of mild gestational diabetes did not reduce the frequency of several commonly reported morbidities associated with diabetic pregnancy, results from a large multicenter randomized trial demonstrated.

However, treatment did lower birth weight and resulted in a 50% reduction in macrosomia, as well as lower neonatal fat mass, rates of shoulder dystocia, cesarean delivery, preeclampsia, and gestational hypertension, Dr. Mark B. Landon said at the annual meeting of the Society for Maternal-Fetal Medicine.

The incidence of gestational diabetes is rising in the United States, said Dr. Landon, professor of obstetrics and gynecology at the Ohio State University, Columbus.

Based largely on results of retrospective single-center studies to date, there has been “widespread acceptance of screening and treatment of gestational diabetes by professional organizations with little evidence of demonstrable benefit.” However, in 2003 and in 2008 the U.S. Preventive Services Task Force issued statements concluding that there is insufficient evidence to determine if a health benefit to the treatment of mild gestational diabetes exists.

The maternal-fetal medicine units network of the Eunice Kennedy Shriver National Institute of Child and Health and Human Development conducted a randomized trial to determine if treatment of mild gestational diabetes reduced perinatal morbidity.

For the study, 958 women with a singleton gestation and who met criteria for mild gestational diabetes (defined as a fasting value of less than 95 mg/dL on a blinded 3-hour oral glucose tolerance test) were allocated to one of two groups. The 485 women in the treatment group received formal nutrition counseling, instruction on self-monitoring of blood glucose, and insulin administration, if necessary. The 473 women in the control group received standard routine obstetric care, and clinicians and study participants were unaware of their glucose tolerance test results.

The primary end point was a composite outcome that consisted of perinatal mortality; neonatal hypoglycemia defined as a value less than 35 mg/dL during the first 2 hours of life without feeding; a serum bilirubin greater than 8 mg/dL between 16 and 36 hours of life, hyperinsulinemia as reflected by a cord blood C-peptide greater than the 95th percentile, or birth trauma.

Dr. Landon reported that the average age of the study participants was 29 years. There were no differences between the groups in the frequency of composite primary neonatal outcome (32% in the treatment group vs. 37% in the control group).

Among secondary outcomes, the researchers observed a significant difference between the treatment and control groups in terms of mean birth weight (3,302 g vs. 3,408 g, respectively), fetal fat mass (427 g vs. 464 g), and the frequency of infants weighing greater than 4,000 g at birth (6% vs. 14%).

There were no differences between the two groups in terms of NICU admission, preterm delivery, respiratory distress syndrome, or need for intravenous glucose treatment.

Women in the treatment group had significantly lower overall rates of cesarean delivery (27% vs. 34%) and rates of cesarean corrected for abnormal presentation and prior cesarean (13% vs. 20%). The rate of shoulder dystocia also was reduced with treatment (2% vs. 4%) as was the rate of preeclampsia and gestational hypertension as a composite (9% vs. 14%).

Dr. Landon had no conflicts to disclose.

There has been widespread acceptance of screening and treatment with little evidence of benefit. DR. LANDON

SAN DIEGO — Treatment of mild gestational diabetes did not reduce the frequency of several commonly reported morbidities associated with diabetic pregnancy, results from a large multicenter randomized trial demonstrated.

However, treatment did lower birth weight and resulted in a 50% reduction in macrosomia, as well as lower neonatal fat mass, rates of shoulder dystocia, cesarean delivery, preeclampsia, and gestational hypertension, Dr. Mark B. Landon said at the annual meeting of the Society for Maternal-Fetal Medicine.

The incidence of gestational diabetes is rising in the United States, said Dr. Landon, professor of obstetrics and gynecology at the Ohio State University, Columbus.

Based largely on results of retrospective single-center studies to date, there has been “widespread acceptance of screening and treatment of gestational diabetes by professional organizations with little evidence of demonstrable benefit.” However, in 2003 and in 2008 the U.S. Preventive Services Task Force issued statements concluding that there is insufficient evidence to determine if a health benefit to the treatment of mild gestational diabetes exists.

The maternal-fetal medicine units network of the Eunice Kennedy Shriver National Institute of Child and Health and Human Development conducted a randomized trial to determine if treatment of mild gestational diabetes reduced perinatal morbidity.

For the study, 958 women with a singleton gestation and who met criteria for mild gestational diabetes (defined as a fasting value of less than 95 mg/dL on a blinded 3-hour oral glucose tolerance test) were allocated to one of two groups. The 485 women in the treatment group received formal nutrition counseling, instruction on self-monitoring of blood glucose, and insulin administration, if necessary. The 473 women in the control group received standard routine obstetric care, and clinicians and study participants were unaware of their glucose tolerance test results.

The primary end point was a composite outcome that consisted of perinatal mortality; neonatal hypoglycemia defined as a value less than 35 mg/dL during the first 2 hours of life without feeding; a serum bilirubin greater than 8 mg/dL between 16 and 36 hours of life, hyperinsulinemia as reflected by a cord blood C-peptide greater than the 95th percentile, or birth trauma.

Dr. Landon reported that the average age of the study participants was 29 years. There were no differences between the groups in the frequency of composite primary neonatal outcome (32% in the treatment group vs. 37% in the control group).

Among secondary outcomes, the researchers observed a significant difference between the treatment and control groups in terms of mean birth weight (3,302 g vs. 3,408 g, respectively), fetal fat mass (427 g vs. 464 g), and the frequency of infants weighing greater than 4,000 g at birth (6% vs. 14%).

There were no differences between the two groups in terms of NICU admission, preterm delivery, respiratory distress syndrome, or need for intravenous glucose treatment.

Women in the treatment group had significantly lower overall rates of cesarean delivery (27% vs. 34%) and rates of cesarean corrected for abnormal presentation and prior cesarean (13% vs. 20%). The rate of shoulder dystocia also was reduced with treatment (2% vs. 4%) as was the rate of preeclampsia and gestational hypertension as a composite (9% vs. 14%).

Dr. Landon had no conflicts to disclose.

There has been widespread acceptance of screening and treatment with little evidence of benefit. DR. LANDON

SAN DIEGO — Treatment of mild gestational diabetes did not reduce the frequency of several commonly reported morbidities associated with diabetic pregnancy, results from a large multicenter randomized trial demonstrated.

However, treatment did lower birth weight and resulted in a 50% reduction in macrosomia, as well as lower neonatal fat mass, rates of shoulder dystocia, cesarean delivery, preeclampsia, and gestational hypertension, Dr. Mark B. Landon said at the annual meeting of the Society for Maternal-Fetal Medicine.

The incidence of gestational diabetes is rising in the United States, said Dr. Landon, professor of obstetrics and gynecology at the Ohio State University, Columbus.

Based largely on results of retrospective single-center studies to date, there has been “widespread acceptance of screening and treatment of gestational diabetes by professional organizations with little evidence of demonstrable benefit.” However, in 2003 and in 2008 the U.S. Preventive Services Task Force issued statements concluding that there is insufficient evidence to determine if a health benefit to the treatment of mild gestational diabetes exists.

The maternal-fetal medicine units network of the Eunice Kennedy Shriver National Institute of Child and Health and Human Development conducted a randomized trial to determine if treatment of mild gestational diabetes reduced perinatal morbidity.

For the study, 958 women with a singleton gestation and who met criteria for mild gestational diabetes (defined as a fasting value of less than 95 mg/dL on a blinded 3-hour oral glucose tolerance test) were allocated to one of two groups. The 485 women in the treatment group received formal nutrition counseling, instruction on self-monitoring of blood glucose, and insulin administration, if necessary. The 473 women in the control group received standard routine obstetric care, and clinicians and study participants were unaware of their glucose tolerance test results.

The primary end point was a composite outcome that consisted of perinatal mortality; neonatal hypoglycemia defined as a value less than 35 mg/dL during the first 2 hours of life without feeding; a serum bilirubin greater than 8 mg/dL between 16 and 36 hours of life, hyperinsulinemia as reflected by a cord blood C-peptide greater than the 95th percentile, or birth trauma.

Dr. Landon reported that the average age of the study participants was 29 years. There were no differences between the groups in the frequency of composite primary neonatal outcome (32% in the treatment group vs. 37% in the control group).

Among secondary outcomes, the researchers observed a significant difference between the treatment and control groups in terms of mean birth weight (3,302 g vs. 3,408 g, respectively), fetal fat mass (427 g vs. 464 g), and the frequency of infants weighing greater than 4,000 g at birth (6% vs. 14%).

There were no differences between the two groups in terms of NICU admission, preterm delivery, respiratory distress syndrome, or need for intravenous glucose treatment.

Women in the treatment group had significantly lower overall rates of cesarean delivery (27% vs. 34%) and rates of cesarean corrected for abnormal presentation and prior cesarean (13% vs. 20%). The rate of shoulder dystocia also was reduced with treatment (2% vs. 4%) as was the rate of preeclampsia and gestational hypertension as a composite (9% vs. 14%).

Dr. Landon had no conflicts to disclose.

There has been widespread acceptance of screening and treatment with little evidence of benefit. DR. LANDON

LAS VEGAS — When using dermal fillers, think of yourself as an artist with a palette of colors, using this one here and that one there.

"There is no ideal filler for all occasions; we need to have a range of fillers," said Dr. Alastair Carruthers, who, with his wife Dr. Jean D.A. Carruthers, pioneered the cosmetic use of botulinum toxin A. "You must always match the patient with the indication and the filler."

At the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery, he went on to discuss his approach to treating specific anatomical areas with various dermal fillers:

▸ Glabella. For this area "you have to inject the frown line superficially, so you want a product that is relatively thin," said Dr. Carruthers, who practices dermatology in Vancouver, B.C.

"Good old Zyderm was wonderful in this area, but you don't want to inject anything that is likely to cause vascular occlusion." For the glabella, he will typically use Restylane, Juvéderm Ultra, or Evolence Breeze in conjunction with Botox.

▸ Infraorbital hollow. He called this area the most difficult to treat consistently well. Even a tiny overcorrection can cause bumps.

"My advice is to always undercorrect," he said. "Always inject supraperiosteally. Hyaluronic acid fillers are great in this area." Diluted Evolence Breeze is another option.

▸ Malar/zygomatic area. For this area, the optimal filler depends on the patient's aversion to risk. Radiesse is going to provide the patient with the best value for the money, "but you're going to get bruising and swelling," said Dr. Carruthers, who is also with the department of dermatology and skin science at the University of British Columbia in Vancouver.

"You're also going to get bruising and swelling to a lesser degree with hyaluronic acid fillers. So for the individual who has a dinner party that night, I would use Evolence."

▸ Cheeks. This is a challenging area to treat from a technical standpoint, but the results for patients with HIV-associated lipoatrophy can be striking. Dr. Carruthers likes to use Radiesse, hyaluronic acid fillers such as Juvéderm Ultra Plus or Perlane, or Evolence.

▸ Nasolabial folds. Since any dermal filler works well in the nasolabial folds, Dr. Carruthers uses "whatever I have in the syringe. I will always be treating other areas and will use the filler I'm already using in the nasolabial folds."

If someone comes in saying that they want their nasolabial folds corrected, "always look at their cheeks to see if they need improvement there as well," he suggested.

"Also, don't overdo it. We've all seen individuals who have seen their nasolabial folds corrected spectacularly. Babies have nasolabial folds. The nasolabial fold is a natural thing; you can soften it but don't try to get rid of it."

▸ Lips. This is another challenging area to treat, one "where you make or lose your reputation in your area of practice," Dr. Carruthers said.

He recommends avoiding the use of permanent fillers in the lips and those that cause fibroplasia, including AlloDerm, and products that contain Gore-Tex.

"Why? Because the lip is so mobile. Even with the soft fillers we put into lips you can still get problems," Dr. Carruthers explained during his presentation. "Be conservative and cautious, and don't try to overtreat the lips."

He said that he uses Evolence Breeze about 70% of the time for correction of the lips. He also uses Restylane and Juvéderm Ultra.

▸ Marionette lines. The area requires a relatively stiff filler such as Juvéderm Ultra Plus, Perlane, or Evolence. Even with these products, however, the results may not be optimal.

"You have to accept that fillers do not hold well in the marionette area," he said. "You should be injecting right down to the jaw line if you're attempting to improve this area."

▸ Chin. When adding volume to this area, be mindful of the branches of the facial artery. "Stay superficial where the facial artery crosses the mandible," he recommended.

Dr. Carruthers noted that bruising is most likely to occur when the dermatologist injects into the lateral part of the chin. To minimize bruising, he recommends injecting posterolaterally from the central chin.

Fillers he uses for the chin include Radiesse, Juvéderm Ultra Plus, Perlane, or Evolence.

Dr. Carruthers disclosed that he is a consultant and performs research for Allergan Inc., Merz GmbH & Co., and Biform Medical Inc.

A patient is shown before receiving Radiesse for lipoatrophy of the cheeks, which can be challenging to treat.

Noticeable results can be seen in the patient's cheek area after treatment with one syringe of Radiesse. PHOTOS COURTESY DR. ALASTAIR CARRUTHERS

'There is no ideal filler. … You must always match the patient with the indication and the filler.' DR. CARRUTHERS

LAS VEGAS — When using dermal fillers, think of yourself as an artist with a palette of colors, using this one here and that one there.

"There is no ideal filler for all occasions; we need to have a range of fillers," said Dr. Alastair Carruthers, who, with his wife Dr. Jean D.A. Carruthers, pioneered the cosmetic use of botulinum toxin A. "You must always match the patient with the indication and the filler."

At the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery, he went on to discuss his approach to treating specific anatomical areas with various dermal fillers:

▸ Glabella. For this area "you have to inject the frown line superficially, so you want a product that is relatively thin," said Dr. Carruthers, who practices dermatology in Vancouver, B.C.

"Good old Zyderm was wonderful in this area, but you don't want to inject anything that is likely to cause vascular occlusion." For the glabella, he will typically use Restylane, Juvéderm Ultra, or Evolence Breeze in conjunction with Botox.

▸ Infraorbital hollow. He called this area the most difficult to treat consistently well. Even a tiny overcorrection can cause bumps.

"My advice is to always undercorrect," he said. "Always inject supraperiosteally. Hyaluronic acid fillers are great in this area." Diluted Evolence Breeze is another option.

▸ Malar/zygomatic area. For this area, the optimal filler depends on the patient's aversion to risk. Radiesse is going to provide the patient with the best value for the money, "but you're going to get bruising and swelling," said Dr. Carruthers, who is also with the department of dermatology and skin science at the University of British Columbia in Vancouver.

"You're also going to get bruising and swelling to a lesser degree with hyaluronic acid fillers. So for the individual who has a dinner party that night, I would use Evolence."

▸ Cheeks. This is a challenging area to treat from a technical standpoint, but the results for patients with HIV-associated lipoatrophy can be striking. Dr. Carruthers likes to use Radiesse, hyaluronic acid fillers such as Juvéderm Ultra Plus or Perlane, or Evolence.

▸ Nasolabial folds. Since any dermal filler works well in the nasolabial folds, Dr. Carruthers uses "whatever I have in the syringe. I will always be treating other areas and will use the filler I'm already using in the nasolabial folds."

If someone comes in saying that they want their nasolabial folds corrected, "always look at their cheeks to see if they need improvement there as well," he suggested.

"Also, don't overdo it. We've all seen individuals who have seen their nasolabial folds corrected spectacularly. Babies have nasolabial folds. The nasolabial fold is a natural thing; you can soften it but don't try to get rid of it."

▸ Lips. This is another challenging area to treat, one "where you make or lose your reputation in your area of practice," Dr. Carruthers said.

He recommends avoiding the use of permanent fillers in the lips and those that cause fibroplasia, including AlloDerm, and products that contain Gore-Tex.

"Why? Because the lip is so mobile. Even with the soft fillers we put into lips you can still get problems," Dr. Carruthers explained during his presentation. "Be conservative and cautious, and don't try to overtreat the lips."

He said that he uses Evolence Breeze about 70% of the time for correction of the lips. He also uses Restylane and Juvéderm Ultra.

▸ Marionette lines. The area requires a relatively stiff filler such as Juvéderm Ultra Plus, Perlane, or Evolence. Even with these products, however, the results may not be optimal.

"You have to accept that fillers do not hold well in the marionette area," he said. "You should be injecting right down to the jaw line if you're attempting to improve this area."

▸ Chin. When adding volume to this area, be mindful of the branches of the facial artery. "Stay superficial where the facial artery crosses the mandible," he recommended.

Dr. Carruthers noted that bruising is most likely to occur when the dermatologist injects into the lateral part of the chin. To minimize bruising, he recommends injecting posterolaterally from the central chin.

Fillers he uses for the chin include Radiesse, Juvéderm Ultra Plus, Perlane, or Evolence.

Dr. Carruthers disclosed that he is a consultant and performs research for Allergan Inc., Merz GmbH & Co., and Biform Medical Inc.

A patient is shown before receiving Radiesse for lipoatrophy of the cheeks, which can be challenging to treat.

Noticeable results can be seen in the patient's cheek area after treatment with one syringe of Radiesse. PHOTOS COURTESY DR. ALASTAIR CARRUTHERS

'There is no ideal filler. … You must always match the patient with the indication and the filler.' DR. CARRUTHERS

LAS VEGAS — When using dermal fillers, think of yourself as an artist with a palette of colors, using this one here and that one there.

"There is no ideal filler for all occasions; we need to have a range of fillers," said Dr. Alastair Carruthers, who, with his wife Dr. Jean D.A. Carruthers, pioneered the cosmetic use of botulinum toxin A. "You must always match the patient with the indication and the filler."

At the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery, he went on to discuss his approach to treating specific anatomical areas with various dermal fillers:

▸ Glabella. For this area "you have to inject the frown line superficially, so you want a product that is relatively thin," said Dr. Carruthers, who practices dermatology in Vancouver, B.C.

"Good old Zyderm was wonderful in this area, but you don't want to inject anything that is likely to cause vascular occlusion." For the glabella, he will typically use Restylane, Juvéderm Ultra, or Evolence Breeze in conjunction with Botox.

▸ Infraorbital hollow. He called this area the most difficult to treat consistently well. Even a tiny overcorrection can cause bumps.

"My advice is to always undercorrect," he said. "Always inject supraperiosteally. Hyaluronic acid fillers are great in this area." Diluted Evolence Breeze is another option.

▸ Malar/zygomatic area. For this area, the optimal filler depends on the patient's aversion to risk. Radiesse is going to provide the patient with the best value for the money, "but you're going to get bruising and swelling," said Dr. Carruthers, who is also with the department of dermatology and skin science at the University of British Columbia in Vancouver.

"You're also going to get bruising and swelling to a lesser degree with hyaluronic acid fillers. So for the individual who has a dinner party that night, I would use Evolence."

▸ Cheeks. This is a challenging area to treat from a technical standpoint, but the results for patients with HIV-associated lipoatrophy can be striking. Dr. Carruthers likes to use Radiesse, hyaluronic acid fillers such as Juvéderm Ultra Plus or Perlane, or Evolence.

▸ Nasolabial folds. Since any dermal filler works well in the nasolabial folds, Dr. Carruthers uses "whatever I have in the syringe. I will always be treating other areas and will use the filler I'm already using in the nasolabial folds."

If someone comes in saying that they want their nasolabial folds corrected, "always look at their cheeks to see if they need improvement there as well," he suggested.

"Also, don't overdo it. We've all seen individuals who have seen their nasolabial folds corrected spectacularly. Babies have nasolabial folds. The nasolabial fold is a natural thing; you can soften it but don't try to get rid of it."

▸ Lips. This is another challenging area to treat, one "where you make or lose your reputation in your area of practice," Dr. Carruthers said.

He recommends avoiding the use of permanent fillers in the lips and those that cause fibroplasia, including AlloDerm, and products that contain Gore-Tex.

"Why? Because the lip is so mobile. Even with the soft fillers we put into lips you can still get problems," Dr. Carruthers explained during his presentation. "Be conservative and cautious, and don't try to overtreat the lips."

He said that he uses Evolence Breeze about 70% of the time for correction of the lips. He also uses Restylane and Juvéderm Ultra.

▸ Marionette lines. The area requires a relatively stiff filler such as Juvéderm Ultra Plus, Perlane, or Evolence. Even with these products, however, the results may not be optimal.

"You have to accept that fillers do not hold well in the marionette area," he said. "You should be injecting right down to the jaw line if you're attempting to improve this area."

▸ Chin. When adding volume to this area, be mindful of the branches of the facial artery. "Stay superficial where the facial artery crosses the mandible," he recommended.

Dr. Carruthers noted that bruising is most likely to occur when the dermatologist injects into the lateral part of the chin. To minimize bruising, he recommends injecting posterolaterally from the central chin.

Fillers he uses for the chin include Radiesse, Juvéderm Ultra Plus, Perlane, or Evolence.

Dr. Carruthers disclosed that he is a consultant and performs research for Allergan Inc., Merz GmbH & Co., and Biform Medical Inc.

A patient is shown before receiving Radiesse for lipoatrophy of the cheeks, which can be challenging to treat.

Noticeable results can be seen in the patient's cheek area after treatment with one syringe of Radiesse. PHOTOS COURTESY DR. ALASTAIR CARRUTHERS

'There is no ideal filler. … You must always match the patient with the indication and the filler.' DR. CARRUTHERS

LAS VEGAS — When Dr. Robert A. Weiss started using the SlimLipo liposuction unit for fat melting and fat sculpting, he was surprised to learn that most patients returned to work the day after the procedure.

"They had almost no bruising," he recalled at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "The tumescent fluid drainage was over in 12 hours instead of 2 or 3 days and I thought, 'We've found something pretty remarkable.'"

Of 10 patients who participated in an institutional review board study led by Dr. Weiss, 4 had their abdomens treated, 3 had their thighs treated, 2 had their flanks treated, and one had the arms treated. No side effects were seen at 6 weeks, and all patients rated the procedure as significantly improving the appearance of fat, said Dr. Weiss of the department of dermatology at Johns Hopkins University, Baltimore, who is also in private practice in that city.

He credited the successful outcomes to technology that simultaneously blends 924-nm and 975-nm wavelengths and the unit's redesigned tip, which became available in May of 2008. "The problem with standard fiber tips is that the temperature gets very high, from 400° to 1,000° F," he said. The redesigned tip is rounded and distributes heat more efficiently.

In experiments on abdominoplasty skin, Dr. Weiss and his associates observed that wavelengths in the 920-nm range achieved fat absorption, whereas wavelengths in the 980-nm range achieved water absorption. He noted that SlimLipo's shorter wavelength and redesigned tip set it apart from other devices used for laser-assisted lipolysis. According to data on the manufacturer's (Palomar Medical Technologies Inc.) Web site, the Food and Drug Administration-cleared unit releases five times as much fat as does the 1,064-nm SmartLipo laser.

"What we're trying to do is overcome the potential disadvantages of laser-assisted lipolysis by making it a shorter procedure time instead of a longer one," he said. "We want to decrease the risk of skin injury [and] eliminate the risk of fibrin breakage, and we want to reduce bruising and tenderness. We can do this by using a wavelength that also shrinks capillaries. Nd:YAG lasers have been typically used to affect fat. These new wavelengths come from diode lasers."

After the SlimLipo tip smoothly irradiates adipose tissue, highly selective wavelengths "melt" adipocytes while coagulating the surrounding connective-tissue meshwork. Liquified fatty acid leaks out through the incision or is easily aspirated though a micro cannula. Coagulated subdermal collagen provides a shrinkage effect that, over time, is replaced by new septa and support meshwork for new improved body contour.

"There is no plasma or mechanical damage, just gentle thermal melting and coagulation," said Dr. Weiss, who noted that most procedures take about 45 minutes.

Dr. Weiss disclosed that he is a consultant, has performed research, and speaks on behalf of many medical device companies, including Palomar.

A 42-year-old patient is shown before and 6 weeks after undergoing treatment with the SlimLipo unit. She has noticed that all of her clothes fit more loosely, according to Dr. Robert A. Weiss. PHOTOS COURTESY DR. ROBERT A. WEISS

LAS VEGAS — When Dr. Robert A. Weiss started using the SlimLipo liposuction unit for fat melting and fat sculpting, he was surprised to learn that most patients returned to work the day after the procedure.

"They had almost no bruising," he recalled at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "The tumescent fluid drainage was over in 12 hours instead of 2 or 3 days and I thought, 'We've found something pretty remarkable.'"

Of 10 patients who participated in an institutional review board study led by Dr. Weiss, 4 had their abdomens treated, 3 had their thighs treated, 2 had their flanks treated, and one had the arms treated. No side effects were seen at 6 weeks, and all patients rated the procedure as significantly improving the appearance of fat, said Dr. Weiss of the department of dermatology at Johns Hopkins University, Baltimore, who is also in private practice in that city.

He credited the successful outcomes to technology that simultaneously blends 924-nm and 975-nm wavelengths and the unit's redesigned tip, which became available in May of 2008. "The problem with standard fiber tips is that the temperature gets very high, from 400° to 1,000° F," he said. The redesigned tip is rounded and distributes heat more efficiently.

In experiments on abdominoplasty skin, Dr. Weiss and his associates observed that wavelengths in the 920-nm range achieved fat absorption, whereas wavelengths in the 980-nm range achieved water absorption. He noted that SlimLipo's shorter wavelength and redesigned tip set it apart from other devices used for laser-assisted lipolysis. According to data on the manufacturer's (Palomar Medical Technologies Inc.) Web site, the Food and Drug Administration-cleared unit releases five times as much fat as does the 1,064-nm SmartLipo laser.

"What we're trying to do is overcome the potential disadvantages of laser-assisted lipolysis by making it a shorter procedure time instead of a longer one," he said. "We want to decrease the risk of skin injury [and] eliminate the risk of fibrin breakage, and we want to reduce bruising and tenderness. We can do this by using a wavelength that also shrinks capillaries. Nd:YAG lasers have been typically used to affect fat. These new wavelengths come from diode lasers."

After the SlimLipo tip smoothly irradiates adipose tissue, highly selective wavelengths "melt" adipocytes while coagulating the surrounding connective-tissue meshwork. Liquified fatty acid leaks out through the incision or is easily aspirated though a micro cannula. Coagulated subdermal collagen provides a shrinkage effect that, over time, is replaced by new septa and support meshwork for new improved body contour.

"There is no plasma or mechanical damage, just gentle thermal melting and coagulation," said Dr. Weiss, who noted that most procedures take about 45 minutes.

Dr. Weiss disclosed that he is a consultant, has performed research, and speaks on behalf of many medical device companies, including Palomar.

A 42-year-old patient is shown before and 6 weeks after undergoing treatment with the SlimLipo unit. She has noticed that all of her clothes fit more loosely, according to Dr. Robert A. Weiss. PHOTOS COURTESY DR. ROBERT A. WEISS

LAS VEGAS — When Dr. Robert A. Weiss started using the SlimLipo liposuction unit for fat melting and fat sculpting, he was surprised to learn that most patients returned to work the day after the procedure.

"They had almost no bruising," he recalled at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "The tumescent fluid drainage was over in 12 hours instead of 2 or 3 days and I thought, 'We've found something pretty remarkable.'"

Of 10 patients who participated in an institutional review board study led by Dr. Weiss, 4 had their abdomens treated, 3 had their thighs treated, 2 had their flanks treated, and one had the arms treated. No side effects were seen at 6 weeks, and all patients rated the procedure as significantly improving the appearance of fat, said Dr. Weiss of the department of dermatology at Johns Hopkins University, Baltimore, who is also in private practice in that city.

He credited the successful outcomes to technology that simultaneously blends 924-nm and 975-nm wavelengths and the unit's redesigned tip, which became available in May of 2008. "The problem with standard fiber tips is that the temperature gets very high, from 400° to 1,000° F," he said. The redesigned tip is rounded and distributes heat more efficiently.

In experiments on abdominoplasty skin, Dr. Weiss and his associates observed that wavelengths in the 920-nm range achieved fat absorption, whereas wavelengths in the 980-nm range achieved water absorption. He noted that SlimLipo's shorter wavelength and redesigned tip set it apart from other devices used for laser-assisted lipolysis. According to data on the manufacturer's (Palomar Medical Technologies Inc.) Web site, the Food and Drug Administration-cleared unit releases five times as much fat as does the 1,064-nm SmartLipo laser.

"What we're trying to do is overcome the potential disadvantages of laser-assisted lipolysis by making it a shorter procedure time instead of a longer one," he said. "We want to decrease the risk of skin injury [and] eliminate the risk of fibrin breakage, and we want to reduce bruising and tenderness. We can do this by using a wavelength that also shrinks capillaries. Nd:YAG lasers have been typically used to affect fat. These new wavelengths come from diode lasers."

After the SlimLipo tip smoothly irradiates adipose tissue, highly selective wavelengths "melt" adipocytes while coagulating the surrounding connective-tissue meshwork. Liquified fatty acid leaks out through the incision or is easily aspirated though a micro cannula. Coagulated subdermal collagen provides a shrinkage effect that, over time, is replaced by new septa and support meshwork for new improved body contour.

"There is no plasma or mechanical damage, just gentle thermal melting and coagulation," said Dr. Weiss, who noted that most procedures take about 45 minutes.

Dr. Weiss disclosed that he is a consultant, has performed research, and speaks on behalf of many medical device companies, including Palomar.

A 42-year-old patient is shown before and 6 weeks after undergoing treatment with the SlimLipo unit. She has noticed that all of her clothes fit more loosely, according to Dr. Robert A. Weiss. PHOTOS COURTESY DR. ROBERT A. WEISS

LAS VEGAS — As part of her pretreatment consultation before providing dermal fillers, Dr. Ranella Hirsch hands a mirror to her patients and instructs them to advise her on their specific goals and expectations.

"I can't tell you how many times I have looked at the patient on a consult, assessed precisely what I thought the ideal aesthetic outcome is, and then be told that it's actually something completely different that they are here for me to treat," Dr. Hirsch said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "A mirror is your friend."

She went on to discuss other ways to avoid potential pitfalls:

▸ Always snap before and after photographs. "There are limited legal protections," said Dr. Hirsch, a dermatologist who practices in Cambridge, Mass. "Before-and-after photographs are one of the few things that will objectively capture accurate data."

▸ Beware of unrealistic expectations. "You need to know what unrealistic expectations are and not treat those people in the first place," she said. "You're not going to make them happy and you're going to make yourself miserable in the process."

▸ Assess for medical contraindications. These include history of hypersensitivity or allergy to known filler ingredients, history of oral herpes simplex virus and keloids, and any problems with scarring. "In my office, we check for these problems three times," said Dr. Hirsch, who is the immediate past president of the ASCDAS. "And it is remarkable how many people neglect to mention these critical points until being asked repeatedly."

▸ Make sure patients can afford the services required for the outcome desired. Be wary of patients who require three syringes of product for optimal results yet only want to pay for one.

▸ Have patients fill out a consent form during every visit. Nothing is more important to the aesthetic physician than informed consent, she emphasized. "I am surprised every time I hear a physician say, 'I use the consent form that came with the job.' Should complications arise, it is critical that this has been done properly to protect yourself."

Describing her own consent forms, she noted, "It's not enough that patients sign at the very bottom of removed pages of small print. They have to sign next to each potential complication and initial it. It has to be witnessed by someone and time stamped. These are critical aspects." She advised checking with an attorney for the best relevant advice.

▸ Educate patients about common side effects. To help reduce the occurrence of purpura, Dr. Hirsch advises patients to eat a lot of pineapple preprocedure, because it contains bromelain. Another option is to take five tablets of arnica, a substance commonly used for muscle pain and bruising, the night before the procedure and another five on the day of the procedure.

Other ways to minimize bruising include applying pressure during and immediately following the injections, using topical anesthesia, mixing the filler with collagen products to stabilize platelets, adding a lidocaine wash to injectables that do not contain an anticoagulant, and using the "push ahead" technique, whereby you get the needle tip to the plane and extrude the needle ahead of the tip. By using this technique, which Dr. Hirsch attributes to Dr. Jean Carruthers, one allows the product rather than the sharp edge of the needle to create the injection plane for the product, thereby reducing tissue trauma (Dermatol. Surg. 2005;31:1604-12).

Should evidence of infection develop after the procedure, incise and drain the abscess as rapidly as possible. Culture the patient for both routine and atypical bacteria and prescribe a course of empiric antibiotics followed by specific antibiotics. "Follow up on those cultures," Dr. Hirsch advised.

If blanching or pain occurs at the injection site, stop immediately, because this can be the only sign of an impending vascular injury. Immediate administration of heat, massage, and nitroglycerin paste helps minimize or reverse permanent injury. A recent case report demonstrated that immediate administration of hyaluronidase can also be of great value (J. Drugs Dermatol. 2007;6:325-8). Once the vascular accident is managed, consider treatment with a pulsed-dye laser or intense pulsed light to improve discoloration.

Dr. Hirsch had no conflicts to disclose relevant to her presentation.

LAS VEGAS — As part of her pretreatment consultation before providing dermal fillers, Dr. Ranella Hirsch hands a mirror to her patients and instructs them to advise her on their specific goals and expectations.

"I can't tell you how many times I have looked at the patient on a consult, assessed precisely what I thought the ideal aesthetic outcome is, and then be told that it's actually something completely different that they are here for me to treat," Dr. Hirsch said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "A mirror is your friend."

She went on to discuss other ways to avoid potential pitfalls:

▸ Always snap before and after photographs. "There are limited legal protections," said Dr. Hirsch, a dermatologist who practices in Cambridge, Mass. "Before-and-after photographs are one of the few things that will objectively capture accurate data."

▸ Beware of unrealistic expectations. "You need to know what unrealistic expectations are and not treat those people in the first place," she said. "You're not going to make them happy and you're going to make yourself miserable in the process."

▸ Assess for medical contraindications. These include history of hypersensitivity or allergy to known filler ingredients, history of oral herpes simplex virus and keloids, and any problems with scarring. "In my office, we check for these problems three times," said Dr. Hirsch, who is the immediate past president of the ASCDAS. "And it is remarkable how many people neglect to mention these critical points until being asked repeatedly."

▸ Make sure patients can afford the services required for the outcome desired. Be wary of patients who require three syringes of product for optimal results yet only want to pay for one.

▸ Have patients fill out a consent form during every visit. Nothing is more important to the aesthetic physician than informed consent, she emphasized. "I am surprised every time I hear a physician say, 'I use the consent form that came with the job.' Should complications arise, it is critical that this has been done properly to protect yourself."

Describing her own consent forms, she noted, "It's not enough that patients sign at the very bottom of removed pages of small print. They have to sign next to each potential complication and initial it. It has to be witnessed by someone and time stamped. These are critical aspects." She advised checking with an attorney for the best relevant advice.

▸ Educate patients about common side effects. To help reduce the occurrence of purpura, Dr. Hirsch advises patients to eat a lot of pineapple preprocedure, because it contains bromelain. Another option is to take five tablets of arnica, a substance commonly used for muscle pain and bruising, the night before the procedure and another five on the day of the procedure.

Other ways to minimize bruising include applying pressure during and immediately following the injections, using topical anesthesia, mixing the filler with collagen products to stabilize platelets, adding a lidocaine wash to injectables that do not contain an anticoagulant, and using the "push ahead" technique, whereby you get the needle tip to the plane and extrude the needle ahead of the tip. By using this technique, which Dr. Hirsch attributes to Dr. Jean Carruthers, one allows the product rather than the sharp edge of the needle to create the injection plane for the product, thereby reducing tissue trauma (Dermatol. Surg. 2005;31:1604-12).

Should evidence of infection develop after the procedure, incise and drain the abscess as rapidly as possible. Culture the patient for both routine and atypical bacteria and prescribe a course of empiric antibiotics followed by specific antibiotics. "Follow up on those cultures," Dr. Hirsch advised.

If blanching or pain occurs at the injection site, stop immediately, because this can be the only sign of an impending vascular injury. Immediate administration of heat, massage, and nitroglycerin paste helps minimize or reverse permanent injury. A recent case report demonstrated that immediate administration of hyaluronidase can also be of great value (J. Drugs Dermatol. 2007;6:325-8). Once the vascular accident is managed, consider treatment with a pulsed-dye laser or intense pulsed light to improve discoloration.

Dr. Hirsch had no conflicts to disclose relevant to her presentation.

LAS VEGAS — As part of her pretreatment consultation before providing dermal fillers, Dr. Ranella Hirsch hands a mirror to her patients and instructs them to advise her on their specific goals and expectations.

"I can't tell you how many times I have looked at the patient on a consult, assessed precisely what I thought the ideal aesthetic outcome is, and then be told that it's actually something completely different that they are here for me to treat," Dr. Hirsch said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "A mirror is your friend."

She went on to discuss other ways to avoid potential pitfalls:

▸ Always snap before and after photographs. "There are limited legal protections," said Dr. Hirsch, a dermatologist who practices in Cambridge, Mass. "Before-and-after photographs are one of the few things that will objectively capture accurate data."

▸ Beware of unrealistic expectations. "You need to know what unrealistic expectations are and not treat those people in the first place," she said. "You're not going to make them happy and you're going to make yourself miserable in the process."

▸ Assess for medical contraindications. These include history of hypersensitivity or allergy to known filler ingredients, history of oral herpes simplex virus and keloids, and any problems with scarring. "In my office, we check for these problems three times," said Dr. Hirsch, who is the immediate past president of the ASCDAS. "And it is remarkable how many people neglect to mention these critical points until being asked repeatedly."

▸ Make sure patients can afford the services required for the outcome desired. Be wary of patients who require three syringes of product for optimal results yet only want to pay for one.

▸ Have patients fill out a consent form during every visit. Nothing is more important to the aesthetic physician than informed consent, she emphasized. "I am surprised every time I hear a physician say, 'I use the consent form that came with the job.' Should complications arise, it is critical that this has been done properly to protect yourself."

Describing her own consent forms, she noted, "It's not enough that patients sign at the very bottom of removed pages of small print. They have to sign next to each potential complication and initial it. It has to be witnessed by someone and time stamped. These are critical aspects." She advised checking with an attorney for the best relevant advice.

▸ Educate patients about common side effects. To help reduce the occurrence of purpura, Dr. Hirsch advises patients to eat a lot of pineapple preprocedure, because it contains bromelain. Another option is to take five tablets of arnica, a substance commonly used for muscle pain and bruising, the night before the procedure and another five on the day of the procedure.

Other ways to minimize bruising include applying pressure during and immediately following the injections, using topical anesthesia, mixing the filler with collagen products to stabilize platelets, adding a lidocaine wash to injectables that do not contain an anticoagulant, and using the "push ahead" technique, whereby you get the needle tip to the plane and extrude the needle ahead of the tip. By using this technique, which Dr. Hirsch attributes to Dr. Jean Carruthers, one allows the product rather than the sharp edge of the needle to create the injection plane for the product, thereby reducing tissue trauma (Dermatol. Surg. 2005;31:1604-12).

Should evidence of infection develop after the procedure, incise and drain the abscess as rapidly as possible. Culture the patient for both routine and atypical bacteria and prescribe a course of empiric antibiotics followed by specific antibiotics. "Follow up on those cultures," Dr. Hirsch advised.

If blanching or pain occurs at the injection site, stop immediately, because this can be the only sign of an impending vascular injury. Immediate administration of heat, massage, and nitroglycerin paste helps minimize or reverse permanent injury. A recent case report demonstrated that immediate administration of hyaluronidase can also be of great value (J. Drugs Dermatol. 2007;6:325-8). Once the vascular accident is managed, consider treatment with a pulsed-dye laser or intense pulsed light to improve discoloration.

Dr. Hirsch had no conflicts to disclose relevant to her presentation.