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Port-Wine Stains May Darken Years After Laser Tx

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Port-Wine Stains May Darken Years After Laser Tx

Port-wine stains treated with a pulsed dye laser—the preferred method of treatment—show significant redarkening years later, reported Dr. Menno Huikeshoven and associates at the University of Amsterdam.

"We recommend that before commencing pulsed dye laser therapy, all patients should be informed of the possibility of redarkening of the stain after treatment," the investigators said in the March 22 issue of the New England Journal of Medicine.

Until now, long-term follow-up data on the results of laser treatment have been scarce and limited to case reports and subjective questionnaires. In this study, Dr. Huikeshoven and associates used objective color measurements to assess treated areas on the face or neck, as well as normally pigmented areas on the contralateral side, in 51 patients who had been treated and similarly assessed in a prospective trial 10 years earlier.

The subjects also completed a questionnaire eliciting their subjective opinion of their treatment results. Their ages at long-term follow-up ranged from 12 to 42 years.

Only color of the lesions was assessed, not other characteristics such as size, surface structure, or degree of hypertrophy, the researchers noted.

The treated areas showed significant redarkening over time, although they remained lighter than they had been before treatment. Of the 51 subjects, 45 sought further pulsed dye laser therapy after their initial five treatments and assessment in the original study.

"It can be concluded that the positive effect of five treatments is not completely durable and that significant redarkening occurs at long-term follow-up," the investigators said (N. Engl. J. Med. 2007;356:1235–40).

Thirty subjects (59%) reported that they were satisfied with the results of treatment, and 21 (41%) reported they were not satisfied.

The subjects tended to underestimate the changes in color in their port wine stains over time, with only 18 (35%) reporting that they believed their stains had darkened. This is probably because the changes occurred slowly over many years.

This finding highlights the importance of using objective measurements to assess possible changes rather than patient or physician questionnaires, the investigators noted.

In a separate interview with SKIN & ALLERGY NEWS, Dr. Robert A. Weiss of the department of dermatology at the John Hopkins University, Baltimore, said, "I would still recommend the treatment to a patient. Even if there is a bit of recurrence, it is still worthwhile to treat," he said adding that patients can be treated again with the pulsed dye laser after redarkening of the stain to lighten it again. "New lasers have become available since thepatients in this study were treated a decade ago," Dr. Weiss said

The investigators stated that whether the new lasers reduce the incidence of redarkening over time "remains to be investigated."

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Port-wine stains treated with a pulsed dye laser—the preferred method of treatment—show significant redarkening years later, reported Dr. Menno Huikeshoven and associates at the University of Amsterdam.

"We recommend that before commencing pulsed dye laser therapy, all patients should be informed of the possibility of redarkening of the stain after treatment," the investigators said in the March 22 issue of the New England Journal of Medicine.

Until now, long-term follow-up data on the results of laser treatment have been scarce and limited to case reports and subjective questionnaires. In this study, Dr. Huikeshoven and associates used objective color measurements to assess treated areas on the face or neck, as well as normally pigmented areas on the contralateral side, in 51 patients who had been treated and similarly assessed in a prospective trial 10 years earlier.

The subjects also completed a questionnaire eliciting their subjective opinion of their treatment results. Their ages at long-term follow-up ranged from 12 to 42 years.

Only color of the lesions was assessed, not other characteristics such as size, surface structure, or degree of hypertrophy, the researchers noted.

The treated areas showed significant redarkening over time, although they remained lighter than they had been before treatment. Of the 51 subjects, 45 sought further pulsed dye laser therapy after their initial five treatments and assessment in the original study.

"It can be concluded that the positive effect of five treatments is not completely durable and that significant redarkening occurs at long-term follow-up," the investigators said (N. Engl. J. Med. 2007;356:1235–40).

Thirty subjects (59%) reported that they were satisfied with the results of treatment, and 21 (41%) reported they were not satisfied.

The subjects tended to underestimate the changes in color in their port wine stains over time, with only 18 (35%) reporting that they believed their stains had darkened. This is probably because the changes occurred slowly over many years.

This finding highlights the importance of using objective measurements to assess possible changes rather than patient or physician questionnaires, the investigators noted.

In a separate interview with SKIN & ALLERGY NEWS, Dr. Robert A. Weiss of the department of dermatology at the John Hopkins University, Baltimore, said, "I would still recommend the treatment to a patient. Even if there is a bit of recurrence, it is still worthwhile to treat," he said adding that patients can be treated again with the pulsed dye laser after redarkening of the stain to lighten it again. "New lasers have become available since thepatients in this study were treated a decade ago," Dr. Weiss said

The investigators stated that whether the new lasers reduce the incidence of redarkening over time "remains to be investigated."

ELSEVIER GLOBAL MEDICAL NEWS

Port-wine stains treated with a pulsed dye laser—the preferred method of treatment—show significant redarkening years later, reported Dr. Menno Huikeshoven and associates at the University of Amsterdam.

"We recommend that before commencing pulsed dye laser therapy, all patients should be informed of the possibility of redarkening of the stain after treatment," the investigators said in the March 22 issue of the New England Journal of Medicine.

Until now, long-term follow-up data on the results of laser treatment have been scarce and limited to case reports and subjective questionnaires. In this study, Dr. Huikeshoven and associates used objective color measurements to assess treated areas on the face or neck, as well as normally pigmented areas on the contralateral side, in 51 patients who had been treated and similarly assessed in a prospective trial 10 years earlier.

The subjects also completed a questionnaire eliciting their subjective opinion of their treatment results. Their ages at long-term follow-up ranged from 12 to 42 years.

Only color of the lesions was assessed, not other characteristics such as size, surface structure, or degree of hypertrophy, the researchers noted.

The treated areas showed significant redarkening over time, although they remained lighter than they had been before treatment. Of the 51 subjects, 45 sought further pulsed dye laser therapy after their initial five treatments and assessment in the original study.

"It can be concluded that the positive effect of five treatments is not completely durable and that significant redarkening occurs at long-term follow-up," the investigators said (N. Engl. J. Med. 2007;356:1235–40).

Thirty subjects (59%) reported that they were satisfied with the results of treatment, and 21 (41%) reported they were not satisfied.

The subjects tended to underestimate the changes in color in their port wine stains over time, with only 18 (35%) reporting that they believed their stains had darkened. This is probably because the changes occurred slowly over many years.

This finding highlights the importance of using objective measurements to assess possible changes rather than patient or physician questionnaires, the investigators noted.

In a separate interview with SKIN & ALLERGY NEWS, Dr. Robert A. Weiss of the department of dermatology at the John Hopkins University, Baltimore, said, "I would still recommend the treatment to a patient. Even if there is a bit of recurrence, it is still worthwhile to treat," he said adding that patients can be treated again with the pulsed dye laser after redarkening of the stain to lighten it again. "New lasers have become available since thepatients in this study were treated a decade ago," Dr. Weiss said

The investigators stated that whether the new lasers reduce the incidence of redarkening over time "remains to be investigated."

ELSEVIER GLOBAL MEDICAL NEWS

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Proper Preop Makes for Easier Toenail Surgery

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WASHINGTON — Proper early management of ingrown toenails may help to decrease the risk of recurrence whether or not surgery is necessary, Dr. C. Ralph Daniel III said at the annual meeting of the American Academy of Dermatology.

"An ingrown nail is primarily acting as a foreign-body reaction. That rigid spicule penetrates soft surrounding tissue" and produces swelling, granulation tissue, and sometimes a secondary infection, said Dr. Daniel of the departments of dermatology at the University of Mississippi, Jackson, and the University of Alabama, Birmingham.

For the early management of stage I ingrown toenails in which some granulation tissue but no infection is present, Dr. Daniel has trained his nurse to push wisps of cotton gently under the involved ingrowing nail by using a 2-mm nail elevator or a 1− to 2-mm curette.

He also uses a technique for early-stage ingrown toenails in which dental floss is inserted under the ingrown nail corner without anesthesia and is kept there to separate the nail edge from adjacent soft tissue (J. Am. Acad. Dermatol. 2004;50:939–40).

Dr. Daniel formerly was on the board of directors for Doak Dermatologics, a subsidiary of Bradley Pharmaceuticals Inc., which manufactures urea-based products for nail care. He holds stock options and has served as a speaker, consultant, and investigator for the company.

A procedure that uses an acrylic-affixed gutter splint has been reported to be successful for avoiding surgery, Dr. Daniel said. A plastic gutter tube is set under the ingrown part of the nail and acrylic is sculpted and allowed to polymerize around the ingrown part of the nail and hold the gutter tube in place. The tubes are removed once the inflammation has subsided and the nail has grown appropriately (Int. J. Dermatol. 2004;43:759–65).

Surgery should not be performed on a patient with an ingrown toenail in a more advanced stage—more granulation tissue, significant pain, possible infection—until the level of inflammation has been reduced with salt soaks in warm water (as opposed to cold, because of the possibility of infection) and topical application of steroids three times a day for about a week, Dr. Daniel said. He doesn't use urea very often in these cases because it does not seem to work as well as it does for early-stage ingrown toenails.

Before surgery, leave plenty of time for anesthesia using a digital block or a distal approach to take effect. Premedication with NSAIDs, codeine, or dextropropoxyphene also may be appropriate, he said. Dr. Daniel uses a timer and does not keep a tourniquet on for more than 15 minutes; most procedures do not take longer than that (some surgeons do not use tourniquets).

To cut away the offending section of nail, an English anvil nail splitter is inserted under the nail plate and the cut is made all the way to the proximal nail fold. The hypertrophic, granulated tissue should be cut away as well. Many ingrown toenails are recurrent, so Dr. Daniel performs a chemical matricectomy in nearly all patients after making sure that the surgical field is dry and bloodless.

The proximal nail fold can be flared back to expose more of the proximal matrix if necessary. He inserts a Calgiswab coated with 88% phenol or 10% sodium hydroxide and applies the chemical for 30 seconds to the portion of the nail matrix that needs to be destroyed.

An Ellman electrode can be used to electrodesiccate the matrix, followed by curettage. The CO2 laser also has been used to perform a partial matricectomy after removal of the nail spicule and staining of the nail matrix with methylene blue (Dermatol. Surg. 2005;31:302–5).

An ingrown toenail is shown. ©Jeff Horn/Fotolia

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WASHINGTON — Proper early management of ingrown toenails may help to decrease the risk of recurrence whether or not surgery is necessary, Dr. C. Ralph Daniel III said at the annual meeting of the American Academy of Dermatology.

"An ingrown nail is primarily acting as a foreign-body reaction. That rigid spicule penetrates soft surrounding tissue" and produces swelling, granulation tissue, and sometimes a secondary infection, said Dr. Daniel of the departments of dermatology at the University of Mississippi, Jackson, and the University of Alabama, Birmingham.

For the early management of stage I ingrown toenails in which some granulation tissue but no infection is present, Dr. Daniel has trained his nurse to push wisps of cotton gently under the involved ingrowing nail by using a 2-mm nail elevator or a 1− to 2-mm curette.

He also uses a technique for early-stage ingrown toenails in which dental floss is inserted under the ingrown nail corner without anesthesia and is kept there to separate the nail edge from adjacent soft tissue (J. Am. Acad. Dermatol. 2004;50:939–40).

Dr. Daniel formerly was on the board of directors for Doak Dermatologics, a subsidiary of Bradley Pharmaceuticals Inc., which manufactures urea-based products for nail care. He holds stock options and has served as a speaker, consultant, and investigator for the company.

A procedure that uses an acrylic-affixed gutter splint has been reported to be successful for avoiding surgery, Dr. Daniel said. A plastic gutter tube is set under the ingrown part of the nail and acrylic is sculpted and allowed to polymerize around the ingrown part of the nail and hold the gutter tube in place. The tubes are removed once the inflammation has subsided and the nail has grown appropriately (Int. J. Dermatol. 2004;43:759–65).

Surgery should not be performed on a patient with an ingrown toenail in a more advanced stage—more granulation tissue, significant pain, possible infection—until the level of inflammation has been reduced with salt soaks in warm water (as opposed to cold, because of the possibility of infection) and topical application of steroids three times a day for about a week, Dr. Daniel said. He doesn't use urea very often in these cases because it does not seem to work as well as it does for early-stage ingrown toenails.

Before surgery, leave plenty of time for anesthesia using a digital block or a distal approach to take effect. Premedication with NSAIDs, codeine, or dextropropoxyphene also may be appropriate, he said. Dr. Daniel uses a timer and does not keep a tourniquet on for more than 15 minutes; most procedures do not take longer than that (some surgeons do not use tourniquets).

To cut away the offending section of nail, an English anvil nail splitter is inserted under the nail plate and the cut is made all the way to the proximal nail fold. The hypertrophic, granulated tissue should be cut away as well. Many ingrown toenails are recurrent, so Dr. Daniel performs a chemical matricectomy in nearly all patients after making sure that the surgical field is dry and bloodless.

The proximal nail fold can be flared back to expose more of the proximal matrix if necessary. He inserts a Calgiswab coated with 88% phenol or 10% sodium hydroxide and applies the chemical for 30 seconds to the portion of the nail matrix that needs to be destroyed.

An Ellman electrode can be used to electrodesiccate the matrix, followed by curettage. The CO2 laser also has been used to perform a partial matricectomy after removal of the nail spicule and staining of the nail matrix with methylene blue (Dermatol. Surg. 2005;31:302–5).

An ingrown toenail is shown. ©Jeff Horn/Fotolia

WASHINGTON — Proper early management of ingrown toenails may help to decrease the risk of recurrence whether or not surgery is necessary, Dr. C. Ralph Daniel III said at the annual meeting of the American Academy of Dermatology.

"An ingrown nail is primarily acting as a foreign-body reaction. That rigid spicule penetrates soft surrounding tissue" and produces swelling, granulation tissue, and sometimes a secondary infection, said Dr. Daniel of the departments of dermatology at the University of Mississippi, Jackson, and the University of Alabama, Birmingham.

For the early management of stage I ingrown toenails in which some granulation tissue but no infection is present, Dr. Daniel has trained his nurse to push wisps of cotton gently under the involved ingrowing nail by using a 2-mm nail elevator or a 1− to 2-mm curette.

He also uses a technique for early-stage ingrown toenails in which dental floss is inserted under the ingrown nail corner without anesthesia and is kept there to separate the nail edge from adjacent soft tissue (J. Am. Acad. Dermatol. 2004;50:939–40).

Dr. Daniel formerly was on the board of directors for Doak Dermatologics, a subsidiary of Bradley Pharmaceuticals Inc., which manufactures urea-based products for nail care. He holds stock options and has served as a speaker, consultant, and investigator for the company.

A procedure that uses an acrylic-affixed gutter splint has been reported to be successful for avoiding surgery, Dr. Daniel said. A plastic gutter tube is set under the ingrown part of the nail and acrylic is sculpted and allowed to polymerize around the ingrown part of the nail and hold the gutter tube in place. The tubes are removed once the inflammation has subsided and the nail has grown appropriately (Int. J. Dermatol. 2004;43:759–65).

Surgery should not be performed on a patient with an ingrown toenail in a more advanced stage—more granulation tissue, significant pain, possible infection—until the level of inflammation has been reduced with salt soaks in warm water (as opposed to cold, because of the possibility of infection) and topical application of steroids three times a day for about a week, Dr. Daniel said. He doesn't use urea very often in these cases because it does not seem to work as well as it does for early-stage ingrown toenails.

Before surgery, leave plenty of time for anesthesia using a digital block or a distal approach to take effect. Premedication with NSAIDs, codeine, or dextropropoxyphene also may be appropriate, he said. Dr. Daniel uses a timer and does not keep a tourniquet on for more than 15 minutes; most procedures do not take longer than that (some surgeons do not use tourniquets).

To cut away the offending section of nail, an English anvil nail splitter is inserted under the nail plate and the cut is made all the way to the proximal nail fold. The hypertrophic, granulated tissue should be cut away as well. Many ingrown toenails are recurrent, so Dr. Daniel performs a chemical matricectomy in nearly all patients after making sure that the surgical field is dry and bloodless.

The proximal nail fold can be flared back to expose more of the proximal matrix if necessary. He inserts a Calgiswab coated with 88% phenol or 10% sodium hydroxide and applies the chemical for 30 seconds to the portion of the nail matrix that needs to be destroyed.

An Ellman electrode can be used to electrodesiccate the matrix, followed by curettage. The CO2 laser also has been used to perform a partial matricectomy after removal of the nail spicule and staining of the nail matrix with methylene blue (Dermatol. Surg. 2005;31:302–5).

An ingrown toenail is shown. ©Jeff Horn/Fotolia

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Unipolar RF Device Goes Deep to Treat Cellulite

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MIAMI BEACH — A unipolar radiofrequency device that is not yet approved in the United States shows promise for the treatment of cellulite, Dr. David J. Goldberg said at a symposium sponsored by the Florida Society of Dermatology and Dermatologic Surgery.

The unipolar handpiece on the Accent device (Alma Lasers Inc.) heats deeper, compared with current devices that have only a bipolar radiofrequency (RF) option, said Dr. Goldberg, who is on the speakers' bureau for Alma Lasers.

In a study by a group of Mexican investigators, the deeper unipolar RF energy penetration—an estimated 2–6 mm deep—noninvasively heated subcutaneous adipose tissue and caused collagen fibers to contract (J. Drugs Dermatol. 2006;5:714–22). In the study, 68% of 26 women demonstrated at least 20% volumetric contraction on ultrasound.

This is a "hot device right now and very popular outside the United States," said Dr. Goldberg of the department of dermatology at Mount Sinai School of Medicine, New York.

Cellulite is more common among whites, its severity increases with age, and it can be hereditary. "Eighty-five percent of women have cellulite, and the other 15% think they do, so it's a big market," he said, adding that "cellulite is going to become the hot topic in aesthetic medicine in the next 5 years."

In another study of 30 women treated with the Accent unipolar RF handpiece, 27 showed improvements in thigh circumference. The mean decrease was 2.45 cm, a finding that is "better than in other studies or with other technologies," Dr. Goldberg said. Participants underwent six treatment sessions over a 12-week period. The study was funded in part by a research grant from Alma Lasers.

Bipolar RF is superficial, but unipolar is more like ultrasound or magnetic resonance imaging. The unipolar device provides a "very high MHz frequency, almost like MRI," he said.

Investigators rated improvement of cellulite on a 1–4 scale. The mean improvement in the study was 2.9.

Treatment is simple and fairly painless, and patients typically get some erythema. The device's cooling tip avoids blistering of the skin. "Patients should feel some warmth—nothing more," he added.

"The typical result is tightening of the skin from deep, diffuse radiofrequency," Dr. Goldberg said. Not everyone, however, is a candidate. "They cannot be fat or have a lot of muscle rippling, but you can get a nice result for loose skin," he said.

There were no significant changes in blood lipids or patient weight during the study. Similarly, MRI scans of the treated areas showed no changes. Histology showed upper dermal fibrosis and tightened collagen formation.

"This Accent device is highly effective for skin tightening," Dr. Goldberg said. "When [it is] FDA approved, it will be a potent device in the treatment of cellulite."

A patient with cellulite is shown before treatment with the Accent device.

Mean improvement among 30 patients was rated at 2.9 on a scale of 1–4. Photos courtesy Dr. David Goldberg

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MIAMI BEACH — A unipolar radiofrequency device that is not yet approved in the United States shows promise for the treatment of cellulite, Dr. David J. Goldberg said at a symposium sponsored by the Florida Society of Dermatology and Dermatologic Surgery.

The unipolar handpiece on the Accent device (Alma Lasers Inc.) heats deeper, compared with current devices that have only a bipolar radiofrequency (RF) option, said Dr. Goldberg, who is on the speakers' bureau for Alma Lasers.

In a study by a group of Mexican investigators, the deeper unipolar RF energy penetration—an estimated 2–6 mm deep—noninvasively heated subcutaneous adipose tissue and caused collagen fibers to contract (J. Drugs Dermatol. 2006;5:714–22). In the study, 68% of 26 women demonstrated at least 20% volumetric contraction on ultrasound.

This is a "hot device right now and very popular outside the United States," said Dr. Goldberg of the department of dermatology at Mount Sinai School of Medicine, New York.

Cellulite is more common among whites, its severity increases with age, and it can be hereditary. "Eighty-five percent of women have cellulite, and the other 15% think they do, so it's a big market," he said, adding that "cellulite is going to become the hot topic in aesthetic medicine in the next 5 years."

In another study of 30 women treated with the Accent unipolar RF handpiece, 27 showed improvements in thigh circumference. The mean decrease was 2.45 cm, a finding that is "better than in other studies or with other technologies," Dr. Goldberg said. Participants underwent six treatment sessions over a 12-week period. The study was funded in part by a research grant from Alma Lasers.

Bipolar RF is superficial, but unipolar is more like ultrasound or magnetic resonance imaging. The unipolar device provides a "very high MHz frequency, almost like MRI," he said.

Investigators rated improvement of cellulite on a 1–4 scale. The mean improvement in the study was 2.9.

Treatment is simple and fairly painless, and patients typically get some erythema. The device's cooling tip avoids blistering of the skin. "Patients should feel some warmth—nothing more," he added.

"The typical result is tightening of the skin from deep, diffuse radiofrequency," Dr. Goldberg said. Not everyone, however, is a candidate. "They cannot be fat or have a lot of muscle rippling, but you can get a nice result for loose skin," he said.

There were no significant changes in blood lipids or patient weight during the study. Similarly, MRI scans of the treated areas showed no changes. Histology showed upper dermal fibrosis and tightened collagen formation.

"This Accent device is highly effective for skin tightening," Dr. Goldberg said. "When [it is] FDA approved, it will be a potent device in the treatment of cellulite."

A patient with cellulite is shown before treatment with the Accent device.

Mean improvement among 30 patients was rated at 2.9 on a scale of 1–4. Photos courtesy Dr. David Goldberg

MIAMI BEACH — A unipolar radiofrequency device that is not yet approved in the United States shows promise for the treatment of cellulite, Dr. David J. Goldberg said at a symposium sponsored by the Florida Society of Dermatology and Dermatologic Surgery.

The unipolar handpiece on the Accent device (Alma Lasers Inc.) heats deeper, compared with current devices that have only a bipolar radiofrequency (RF) option, said Dr. Goldberg, who is on the speakers' bureau for Alma Lasers.

In a study by a group of Mexican investigators, the deeper unipolar RF energy penetration—an estimated 2–6 mm deep—noninvasively heated subcutaneous adipose tissue and caused collagen fibers to contract (J. Drugs Dermatol. 2006;5:714–22). In the study, 68% of 26 women demonstrated at least 20% volumetric contraction on ultrasound.

This is a "hot device right now and very popular outside the United States," said Dr. Goldberg of the department of dermatology at Mount Sinai School of Medicine, New York.

Cellulite is more common among whites, its severity increases with age, and it can be hereditary. "Eighty-five percent of women have cellulite, and the other 15% think they do, so it's a big market," he said, adding that "cellulite is going to become the hot topic in aesthetic medicine in the next 5 years."

In another study of 30 women treated with the Accent unipolar RF handpiece, 27 showed improvements in thigh circumference. The mean decrease was 2.45 cm, a finding that is "better than in other studies or with other technologies," Dr. Goldberg said. Participants underwent six treatment sessions over a 12-week period. The study was funded in part by a research grant from Alma Lasers.

Bipolar RF is superficial, but unipolar is more like ultrasound or magnetic resonance imaging. The unipolar device provides a "very high MHz frequency, almost like MRI," he said.

Investigators rated improvement of cellulite on a 1–4 scale. The mean improvement in the study was 2.9.

Treatment is simple and fairly painless, and patients typically get some erythema. The device's cooling tip avoids blistering of the skin. "Patients should feel some warmth—nothing more," he added.

"The typical result is tightening of the skin from deep, diffuse radiofrequency," Dr. Goldberg said. Not everyone, however, is a candidate. "They cannot be fat or have a lot of muscle rippling, but you can get a nice result for loose skin," he said.

There were no significant changes in blood lipids or patient weight during the study. Similarly, MRI scans of the treated areas showed no changes. Histology showed upper dermal fibrosis and tightened collagen formation.

"This Accent device is highly effective for skin tightening," Dr. Goldberg said. "When [it is] FDA approved, it will be a potent device in the treatment of cellulite."

A patient with cellulite is shown before treatment with the Accent device.

Mean improvement among 30 patients was rated at 2.9 on a scale of 1–4. Photos courtesy Dr. David Goldberg

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Skill, Technique Are Critical With Permanent Filler

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MIAMI BEACH — With expertise and the right technique, aesthetic surgery patients can get long-lasting results from the first permanent facial filler approved by the Food and Drug Administration, Dr. Marta I. Rendon said at a symposium sponsored by the Florida Society of Dermatology and Dermatologic Surgery.

"You can correct things that need to be corrected long term, such as birth defects," Dr. Rendon said, "but stay away from thin-skin areas, for example, around eyes and lips."

ArteFill (Artes Medical Inc.) became the first nonresorbable injectable filler implant approved for aesthetic use in October 2006. The official FDA indication is for correction of nasolabial folds. Dr. Rendon is a member of Artes Medical's advisory board.

Inject the product deeply using a 26G needle. "You never want to see the gray of the needle when you are injecting," she said. Employ a linear retrograde tunneling technique. Stop the injection before you withdraw the needle to avoid superficial placement.

The filler is thicker than most other aesthetic products. ArteFill is, for example, about three times thicker than Zyplast, said Dr. Rendon of the University of Miami.

ArteFill consists of polymethylmethacrylate microspheres suspended in a gel carrier of rapidly-dissolving bovine collagen. The microspheres are 30–50 mcm and stimulate the patient's own collagen to form a permanent support structure beneath the skin. The manufacturer had to demonstrate the uniformity of these microspheres prior to approval.

Dr. Rendon said that any microsphere smaller than 20 mcm would be absorbed by macrophages.

A closed herd of cattle to provide the collagen and a manufacturing facility in the United States were additional requirements.

These conditions stem from concerns that the FDA had following studies of an earlier formulation, ArteColl. In a clinical trial of ArteColl in 251 patients, for example, there were 10 reports of lumpiness, including 1 case that was severe.

Granuloma formation is a concern with all injectable fillers. "Most are late onset and the majority are in the perioral area," she said. This is one reason she advises against use of ArteFill in thin-skin areas.

There were no granuloma reports at a 1-year follow-up in the ArteFill clinical trial, but there were two granulomas at a 5-year follow-up. One was excised from a patient's lip and the other was treated with steroid injections into a nasolabial fold.

A total of 142 participants were assessed at a mean of 5.4 years, and 90% reported satisfaction. "Patient cosmetic appearance continued to improve. You can still see an upward slope in improvement over 5 years," Dr. Rendon said.

"These patients look younger at 5 years than before treatment," Dr. Rendon said. "We are almost halting the aging process in these patients." Keep in mind, though, that all fillers are foreign bodies, and they may interact with drugs, trauma, and surgery years after implantation.

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MIAMI BEACH — With expertise and the right technique, aesthetic surgery patients can get long-lasting results from the first permanent facial filler approved by the Food and Drug Administration, Dr. Marta I. Rendon said at a symposium sponsored by the Florida Society of Dermatology and Dermatologic Surgery.

"You can correct things that need to be corrected long term, such as birth defects," Dr. Rendon said, "but stay away from thin-skin areas, for example, around eyes and lips."

ArteFill (Artes Medical Inc.) became the first nonresorbable injectable filler implant approved for aesthetic use in October 2006. The official FDA indication is for correction of nasolabial folds. Dr. Rendon is a member of Artes Medical's advisory board.

Inject the product deeply using a 26G needle. "You never want to see the gray of the needle when you are injecting," she said. Employ a linear retrograde tunneling technique. Stop the injection before you withdraw the needle to avoid superficial placement.

The filler is thicker than most other aesthetic products. ArteFill is, for example, about three times thicker than Zyplast, said Dr. Rendon of the University of Miami.

ArteFill consists of polymethylmethacrylate microspheres suspended in a gel carrier of rapidly-dissolving bovine collagen. The microspheres are 30–50 mcm and stimulate the patient's own collagen to form a permanent support structure beneath the skin. The manufacturer had to demonstrate the uniformity of these microspheres prior to approval.

Dr. Rendon said that any microsphere smaller than 20 mcm would be absorbed by macrophages.

A closed herd of cattle to provide the collagen and a manufacturing facility in the United States were additional requirements.

These conditions stem from concerns that the FDA had following studies of an earlier formulation, ArteColl. In a clinical trial of ArteColl in 251 patients, for example, there were 10 reports of lumpiness, including 1 case that was severe.

Granuloma formation is a concern with all injectable fillers. "Most are late onset and the majority are in the perioral area," she said. This is one reason she advises against use of ArteFill in thin-skin areas.

There were no granuloma reports at a 1-year follow-up in the ArteFill clinical trial, but there were two granulomas at a 5-year follow-up. One was excised from a patient's lip and the other was treated with steroid injections into a nasolabial fold.

A total of 142 participants were assessed at a mean of 5.4 years, and 90% reported satisfaction. "Patient cosmetic appearance continued to improve. You can still see an upward slope in improvement over 5 years," Dr. Rendon said.

"These patients look younger at 5 years than before treatment," Dr. Rendon said. "We are almost halting the aging process in these patients." Keep in mind, though, that all fillers are foreign bodies, and they may interact with drugs, trauma, and surgery years after implantation.

MIAMI BEACH — With expertise and the right technique, aesthetic surgery patients can get long-lasting results from the first permanent facial filler approved by the Food and Drug Administration, Dr. Marta I. Rendon said at a symposium sponsored by the Florida Society of Dermatology and Dermatologic Surgery.

"You can correct things that need to be corrected long term, such as birth defects," Dr. Rendon said, "but stay away from thin-skin areas, for example, around eyes and lips."

ArteFill (Artes Medical Inc.) became the first nonresorbable injectable filler implant approved for aesthetic use in October 2006. The official FDA indication is for correction of nasolabial folds. Dr. Rendon is a member of Artes Medical's advisory board.

Inject the product deeply using a 26G needle. "You never want to see the gray of the needle when you are injecting," she said. Employ a linear retrograde tunneling technique. Stop the injection before you withdraw the needle to avoid superficial placement.

The filler is thicker than most other aesthetic products. ArteFill is, for example, about three times thicker than Zyplast, said Dr. Rendon of the University of Miami.

ArteFill consists of polymethylmethacrylate microspheres suspended in a gel carrier of rapidly-dissolving bovine collagen. The microspheres are 30–50 mcm and stimulate the patient's own collagen to form a permanent support structure beneath the skin. The manufacturer had to demonstrate the uniformity of these microspheres prior to approval.

Dr. Rendon said that any microsphere smaller than 20 mcm would be absorbed by macrophages.

A closed herd of cattle to provide the collagen and a manufacturing facility in the United States were additional requirements.

These conditions stem from concerns that the FDA had following studies of an earlier formulation, ArteColl. In a clinical trial of ArteColl in 251 patients, for example, there were 10 reports of lumpiness, including 1 case that was severe.

Granuloma formation is a concern with all injectable fillers. "Most are late onset and the majority are in the perioral area," she said. This is one reason she advises against use of ArteFill in thin-skin areas.

There were no granuloma reports at a 1-year follow-up in the ArteFill clinical trial, but there were two granulomas at a 5-year follow-up. One was excised from a patient's lip and the other was treated with steroid injections into a nasolabial fold.

A total of 142 participants were assessed at a mean of 5.4 years, and 90% reported satisfaction. "Patient cosmetic appearance continued to improve. You can still see an upward slope in improvement over 5 years," Dr. Rendon said.

"These patients look younger at 5 years than before treatment," Dr. Rendon said. "We are almost halting the aging process in these patients." Keep in mind, though, that all fillers are foreign bodies, and they may interact with drugs, trauma, and surgery years after implantation.

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