Aesthetic Dermatology

DANA POINT, CALIF. – Be wary of clinicians who claim that they never have complications from laser surgery procedures, Dr. A. Jay Burns advised physicians to tell their patients at the Summit in Aesthetic Medicine.

Such clinicians "are either liars, or they’ve only practiced for about 5 minutes," Dr. Burns, of the Dallas Plastic Surgery Institute, said at the meeting, sponsored by Skin Disease Education Foundation (SDEF). "I tell my patients to run from them. We all have complications."

In general, he continued, complications "decrease the better you are trained and the more detail-oriented you are. I don’t know how you legislate that. You also have to care; you have to have compassion."

During separate presentations, he and Dr. Eric F. Bernstein, a board-certified dermatologist who practices laser surgery in Ardmore, Pa., offered practical tips on how to best prevent complications from laser surgery, including the following:

• Know thy laser. "In general, there is less margin for error the cheaper the device, the more corners cut in research and development, the smaller the spot size, and the use of manual treatment versus scanned treatment," Dr. Burns said. "Complications can be minimized by good technique and good postoperative care."

• Don’t take treatment advice from sales representatives. "You are responsible for the treatment no matter what, so research the science and talk to colleagues," Dr. Bernstein said. "I have three words for sales reps bringing a device they tout as safe and effective: ‘Have a seat!’ Sales reps who believe in their products will happily be your first patient, and they will come back for follow-up. You can count on it."

• Take note of special patient populations. Make sure to ask patients about isotretinoin use. "Most of my colleagues and I wait 6 months after patients have discontinued isotretinoin before laser treatment," Dr. Bernstein said. "In most situations I think that’s the standard of care."

Depending on the laser, he prescribes valacyclovir as prophylaxis in patients with a history of herpes simplex virus or for ablative procedures in any patient. He said that he does not treat patients who have taken gold therapy at any time in their life with lasers, as their skin "will turn gray or black at the site of every laser pulse. This is on my consent form."

Patients with systemic lupus and other connective tissue diseases can flare locally and possibly systemically after treatment with vascular lasers, so he generally avoids treating these patients or treats with caution after spot testing.

He does not treat pregnant patients with elective laser procedures, "although I don’t believe there is any risk from the lasers I use," Dr. Bernstein said. "I treated my wife during her pregnancy because she had so much free time from work during that time. However, we’re in America, and until the legal climate changes dramatically, I just avoid performing elective laser treatments on pregnant patients. Tattoo removal is probably the one case where it is actually less advised to treat patients during pregnancy for medical reasons. That’s because the tattoo pigment as a chemical can become mobilized following laser treatment, not because of the laser."

Sun exposure "is probably the biggest issue that causes complications in patients," he continued. "I tell every laser surgeon to respect melanin pigment, as it is an unwanted target in the skin and can absorb laser light, making the epidermis an unwanted target. In addition, a tan makes for more risk of post-inflammatory hyper- or hypopigmentation following treatment. Patients are rarely honest about their sun exposure."

• Wear protective eyewear while operating the laser. Dr. Bernstein locks the door to the laser room while he treats patients "because I think it’s inappropriate to have laser glasses outside your room and open the door and walk in with the glasses, exposing the people outside the door or walking by to laser light. This may be against certain regulations, since those outside the room would have a hard time entering in the event of a problem, but I am never alone in a room with a patient, and prefer this rule for eye safety."

When someone hands you a pair of protective laser glasses, "look at the wavelength ranges and make sure that they correspond to the wavelength of the laser," he advised. "We all check each other’s glasses to make sure they are the right wavelength. Obviously, it’s best to have only one wavelength per room and have glasses for that laser; however, in my office that’s not possible."

• If patients say they’re in pain, stop. Some people have a low tolerance for pain, "but that’s not the time to debate their pain threshold," Dr. Burns noted.

• Debridement and pretreatment. In Dr. Burns’ practice, the regimen for all patients undergoing ablative resurfacing includes changes of Flexzan wound dressing and debridement at 1, 3, and 5 days, cephalexin 250 mg t.i.d. for 5 days, and valacyclovir 500 mg b.i.d. for 10 days.

• Expect maintenance treatments for laser hair removal cases. "Everybody is different, but because of the hair cycle it takes four to six initial treatments, 6 weeks apart, to expose all of the hair in a given area to the laser," Dr. Bernstein said. "Maintenance treatments are always required to keep all of the hair away in a given area."

Prior to performing hair removal procedures in the perioral region, he places two folded pieces of 4-by-4-inch gauze into the patient’s mouth to protect the teeth. "Use nonstick gauze with braces or be ready for a half-hour extraction," he said.

Dr. Bernstein disclosed that he has received research support from Syneron, Cynosure, and Cutera, and Solta Medical. He also serves as a paid consultant for Tria Beauty.

Dr. Burns disclosed that he receives equipment discounts from Cutera, Cynosure, Palomar, Sciton, and Aesthetic Medical Lasers; research support from Sciton, Solta Medical, Ulthera, and Zeltiq; and consulting fees from Ulthera and Zeltiq. He also holds stock in SkinMedica and Zeltiq.

SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – Be wary of clinicians who claim that they never have complications from laser surgery procedures, Dr. A. Jay Burns advised physicians to tell their patients at the Summit in Aesthetic Medicine.

Such clinicians "are either liars, or they’ve only practiced for about 5 minutes," Dr. Burns, of the Dallas Plastic Surgery Institute, said at the meeting, sponsored by Skin Disease Education Foundation (SDEF). "I tell my patients to run from them. We all have complications."

In general, he continued, complications "decrease the better you are trained and the more detail-oriented you are. I don’t know how you legislate that. You also have to care; you have to have compassion."

During separate presentations, he and Dr. Eric F. Bernstein, a board-certified dermatologist who practices laser surgery in Ardmore, Pa., offered practical tips on how to best prevent complications from laser surgery, including the following:

• Know thy laser. "In general, there is less margin for error the cheaper the device, the more corners cut in research and development, the smaller the spot size, and the use of manual treatment versus scanned treatment," Dr. Burns said. "Complications can be minimized by good technique and good postoperative care."

• Don’t take treatment advice from sales representatives. "You are responsible for the treatment no matter what, so research the science and talk to colleagues," Dr. Bernstein said. "I have three words for sales reps bringing a device they tout as safe and effective: ‘Have a seat!’ Sales reps who believe in their products will happily be your first patient, and they will come back for follow-up. You can count on it."

• Take note of special patient populations. Make sure to ask patients about isotretinoin use. "Most of my colleagues and I wait 6 months after patients have discontinued isotretinoin before laser treatment," Dr. Bernstein said. "In most situations I think that’s the standard of care."

Depending on the laser, he prescribes valacyclovir as prophylaxis in patients with a history of herpes simplex virus or for ablative procedures in any patient. He said that he does not treat patients who have taken gold therapy at any time in their life with lasers, as their skin "will turn gray or black at the site of every laser pulse. This is on my consent form."

Patients with systemic lupus and other connective tissue diseases can flare locally and possibly systemically after treatment with vascular lasers, so he generally avoids treating these patients or treats with caution after spot testing.

He does not treat pregnant patients with elective laser procedures, "although I don’t believe there is any risk from the lasers I use," Dr. Bernstein said. "I treated my wife during her pregnancy because she had so much free time from work during that time. However, we’re in America, and until the legal climate changes dramatically, I just avoid performing elective laser treatments on pregnant patients. Tattoo removal is probably the one case where it is actually less advised to treat patients during pregnancy for medical reasons. That’s because the tattoo pigment as a chemical can become mobilized following laser treatment, not because of the laser."

Sun exposure "is probably the biggest issue that causes complications in patients," he continued. "I tell every laser surgeon to respect melanin pigment, as it is an unwanted target in the skin and can absorb laser light, making the epidermis an unwanted target. In addition, a tan makes for more risk of post-inflammatory hyper- or hypopigmentation following treatment. Patients are rarely honest about their sun exposure."

• Wear protective eyewear while operating the laser. Dr. Bernstein locks the door to the laser room while he treats patients "because I think it’s inappropriate to have laser glasses outside your room and open the door and walk in with the glasses, exposing the people outside the door or walking by to laser light. This may be against certain regulations, since those outside the room would have a hard time entering in the event of a problem, but I am never alone in a room with a patient, and prefer this rule for eye safety."

When someone hands you a pair of protective laser glasses, "look at the wavelength ranges and make sure that they correspond to the wavelength of the laser," he advised. "We all check each other’s glasses to make sure they are the right wavelength. Obviously, it’s best to have only one wavelength per room and have glasses for that laser; however, in my office that’s not possible."

• If patients say they’re in pain, stop. Some people have a low tolerance for pain, "but that’s not the time to debate their pain threshold," Dr. Burns noted.

• Debridement and pretreatment. In Dr. Burns’ practice, the regimen for all patients undergoing ablative resurfacing includes changes of Flexzan wound dressing and debridement at 1, 3, and 5 days, cephalexin 250 mg t.i.d. for 5 days, and valacyclovir 500 mg b.i.d. for 10 days.

• Expect maintenance treatments for laser hair removal cases. "Everybody is different, but because of the hair cycle it takes four to six initial treatments, 6 weeks apart, to expose all of the hair in a given area to the laser," Dr. Bernstein said. "Maintenance treatments are always required to keep all of the hair away in a given area."

Prior to performing hair removal procedures in the perioral region, he places two folded pieces of 4-by-4-inch gauze into the patient’s mouth to protect the teeth. "Use nonstick gauze with braces or be ready for a half-hour extraction," he said.

Dr. Bernstein disclosed that he has received research support from Syneron, Cynosure, and Cutera, and Solta Medical. He also serves as a paid consultant for Tria Beauty.

Dr. Burns disclosed that he receives equipment discounts from Cutera, Cynosure, Palomar, Sciton, and Aesthetic Medical Lasers; research support from Sciton, Solta Medical, Ulthera, and Zeltiq; and consulting fees from Ulthera and Zeltiq. He also holds stock in SkinMedica and Zeltiq.

SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – Be wary of clinicians who claim that they never have complications from laser surgery procedures, Dr. A. Jay Burns advised physicians to tell their patients at the Summit in Aesthetic Medicine.

Such clinicians "are either liars, or they’ve only practiced for about 5 minutes," Dr. Burns, of the Dallas Plastic Surgery Institute, said at the meeting, sponsored by Skin Disease Education Foundation (SDEF). "I tell my patients to run from them. We all have complications."

In general, he continued, complications "decrease the better you are trained and the more detail-oriented you are. I don’t know how you legislate that. You also have to care; you have to have compassion."

During separate presentations, he and Dr. Eric F. Bernstein, a board-certified dermatologist who practices laser surgery in Ardmore, Pa., offered practical tips on how to best prevent complications from laser surgery, including the following:

• Know thy laser. "In general, there is less margin for error the cheaper the device, the more corners cut in research and development, the smaller the spot size, and the use of manual treatment versus scanned treatment," Dr. Burns said. "Complications can be minimized by good technique and good postoperative care."

• Don’t take treatment advice from sales representatives. "You are responsible for the treatment no matter what, so research the science and talk to colleagues," Dr. Bernstein said. "I have three words for sales reps bringing a device they tout as safe and effective: ‘Have a seat!’ Sales reps who believe in their products will happily be your first patient, and they will come back for follow-up. You can count on it."

• Take note of special patient populations. Make sure to ask patients about isotretinoin use. "Most of my colleagues and I wait 6 months after patients have discontinued isotretinoin before laser treatment," Dr. Bernstein said. "In most situations I think that’s the standard of care."

Depending on the laser, he prescribes valacyclovir as prophylaxis in patients with a history of herpes simplex virus or for ablative procedures in any patient. He said that he does not treat patients who have taken gold therapy at any time in their life with lasers, as their skin "will turn gray or black at the site of every laser pulse. This is on my consent form."

Patients with systemic lupus and other connective tissue diseases can flare locally and possibly systemically after treatment with vascular lasers, so he generally avoids treating these patients or treats with caution after spot testing.

He does not treat pregnant patients with elective laser procedures, "although I don’t believe there is any risk from the lasers I use," Dr. Bernstein said. "I treated my wife during her pregnancy because she had so much free time from work during that time. However, we’re in America, and until the legal climate changes dramatically, I just avoid performing elective laser treatments on pregnant patients. Tattoo removal is probably the one case where it is actually less advised to treat patients during pregnancy for medical reasons. That’s because the tattoo pigment as a chemical can become mobilized following laser treatment, not because of the laser."

Sun exposure "is probably the biggest issue that causes complications in patients," he continued. "I tell every laser surgeon to respect melanin pigment, as it is an unwanted target in the skin and can absorb laser light, making the epidermis an unwanted target. In addition, a tan makes for more risk of post-inflammatory hyper- or hypopigmentation following treatment. Patients are rarely honest about their sun exposure."

• Wear protective eyewear while operating the laser. Dr. Bernstein locks the door to the laser room while he treats patients "because I think it’s inappropriate to have laser glasses outside your room and open the door and walk in with the glasses, exposing the people outside the door or walking by to laser light. This may be against certain regulations, since those outside the room would have a hard time entering in the event of a problem, but I am never alone in a room with a patient, and prefer this rule for eye safety."

When someone hands you a pair of protective laser glasses, "look at the wavelength ranges and make sure that they correspond to the wavelength of the laser," he advised. "We all check each other’s glasses to make sure they are the right wavelength. Obviously, it’s best to have only one wavelength per room and have glasses for that laser; however, in my office that’s not possible."

• If patients say they’re in pain, stop. Some people have a low tolerance for pain, "but that’s not the time to debate their pain threshold," Dr. Burns noted.

• Debridement and pretreatment. In Dr. Burns’ practice, the regimen for all patients undergoing ablative resurfacing includes changes of Flexzan wound dressing and debridement at 1, 3, and 5 days, cephalexin 250 mg t.i.d. for 5 days, and valacyclovir 500 mg b.i.d. for 10 days.

• Expect maintenance treatments for laser hair removal cases. "Everybody is different, but because of the hair cycle it takes four to six initial treatments, 6 weeks apart, to expose all of the hair in a given area to the laser," Dr. Bernstein said. "Maintenance treatments are always required to keep all of the hair away in a given area."

Prior to performing hair removal procedures in the perioral region, he places two folded pieces of 4-by-4-inch gauze into the patient’s mouth to protect the teeth. "Use nonstick gauze with braces or be ready for a half-hour extraction," he said.

Dr. Bernstein disclosed that he has received research support from Syneron, Cynosure, and Cutera, and Solta Medical. He also serves as a paid consultant for Tria Beauty.

Dr. Burns disclosed that he receives equipment discounts from Cutera, Cynosure, Palomar, Sciton, and Aesthetic Medical Lasers; research support from Sciton, Solta Medical, Ulthera, and Zeltiq; and consulting fees from Ulthera and Zeltiq. He also holds stock in SkinMedica and Zeltiq.

SDEF and this news organization are owned by Elsevier.

SEOUL, SOUTH KOREA — The hyaluronic acid filler Voluma demonstrated excellent efficacy, durability, and patient satisfaction in correcting midface volume deficits at the interim 78-week analysis in a large prospective multicenter study.

At 78 weeks, 84% of patients maintained a clinically meaningful improvement after a single baseline injection and a touch-up injection, if needed, at week 4, Dr. Greg J. Goodman said at the World Congress of Dermatology.

Moreover, 95% of participants pronounced themselves satisfied or very satisfied with the product at the 78-week mark. An equal percentage indicated they would recommend the treatment to others, added Dr. Goodman of Monash University, Melbourne.

Based upon these interim results of what will be a 104-week study – the first-ever formal study of the filler’s long-term effects in daily clinical practice – correction of mild to severe midface volume deficits with Voluma is a safe, effective, long-lasting, and cost-effective alternative to surgical correction, he continued.

The study involved 103 middle-aged subjects with a baseline score of 2-5 on the 6-point Mid-Face Volume-Deficit Scale (MVDS). They were corrected to a 0 or 1, meaning no or mild deficit, by means of a baseline injection of up to 2 cc of Voluma per side. This was followed by an additional injection of up to 2 cc per side if needed at week 4. Patients received a mean total volume of 3.1 mL per side. No further retreatment was permitted until week 78.

A greater than 1-point improvement over baseline MVDS was present in 96% of patients at week 8, 90% at week 52, and 84% at week 78. Similarly, 100% of patients had a greater than 1-point improvement on the 5-point Global Aesthetic Improvement Scale (GAIS)at week 8, 92% at week 52, and 82% at week 78. In all, 78% of patients rated themselves as having more than a 1-point improvement on the GAIS at week 78.

At week 78, 32% of patients received a supplemental injection of Voluma, based upon protocol-defined criteria indicating they had returned to within less than 1 MVDS point of their pretreatment midface volume.

The chief side effect of treatment was mild to moderate bruising at the injection site. This was much more common early in the study, when Voluma was new to Australian physicians.

"We were finding our way back then," Dr. Goodman recalled.

The study was sponsored by Allergan. Dr. Goodman is a consultant to the company.

SEOUL, SOUTH KOREA — The hyaluronic acid filler Voluma demonstrated excellent efficacy, durability, and patient satisfaction in correcting midface volume deficits at the interim 78-week analysis in a large prospective multicenter study.

At 78 weeks, 84% of patients maintained a clinically meaningful improvement after a single baseline injection and a touch-up injection, if needed, at week 4, Dr. Greg J. Goodman said at the World Congress of Dermatology.

Moreover, 95% of participants pronounced themselves satisfied or very satisfied with the product at the 78-week mark. An equal percentage indicated they would recommend the treatment to others, added Dr. Goodman of Monash University, Melbourne.

Based upon these interim results of what will be a 104-week study – the first-ever formal study of the filler’s long-term effects in daily clinical practice – correction of mild to severe midface volume deficits with Voluma is a safe, effective, long-lasting, and cost-effective alternative to surgical correction, he continued.

The study involved 103 middle-aged subjects with a baseline score of 2-5 on the 6-point Mid-Face Volume-Deficit Scale (MVDS). They were corrected to a 0 or 1, meaning no or mild deficit, by means of a baseline injection of up to 2 cc of Voluma per side. This was followed by an additional injection of up to 2 cc per side if needed at week 4. Patients received a mean total volume of 3.1 mL per side. No further retreatment was permitted until week 78.

A greater than 1-point improvement over baseline MVDS was present in 96% of patients at week 8, 90% at week 52, and 84% at week 78. Similarly, 100% of patients had a greater than 1-point improvement on the 5-point Global Aesthetic Improvement Scale (GAIS)at week 8, 92% at week 52, and 82% at week 78. In all, 78% of patients rated themselves as having more than a 1-point improvement on the GAIS at week 78.

At week 78, 32% of patients received a supplemental injection of Voluma, based upon protocol-defined criteria indicating they had returned to within less than 1 MVDS point of their pretreatment midface volume.

The chief side effect of treatment was mild to moderate bruising at the injection site. This was much more common early in the study, when Voluma was new to Australian physicians.

"We were finding our way back then," Dr. Goodman recalled.

The study was sponsored by Allergan. Dr. Goodman is a consultant to the company.

SEOUL, SOUTH KOREA — The hyaluronic acid filler Voluma demonstrated excellent efficacy, durability, and patient satisfaction in correcting midface volume deficits at the interim 78-week analysis in a large prospective multicenter study.

At 78 weeks, 84% of patients maintained a clinically meaningful improvement after a single baseline injection and a touch-up injection, if needed, at week 4, Dr. Greg J. Goodman said at the World Congress of Dermatology.

Moreover, 95% of participants pronounced themselves satisfied or very satisfied with the product at the 78-week mark. An equal percentage indicated they would recommend the treatment to others, added Dr. Goodman of Monash University, Melbourne.

Based upon these interim results of what will be a 104-week study – the first-ever formal study of the filler’s long-term effects in daily clinical practice – correction of mild to severe midface volume deficits with Voluma is a safe, effective, long-lasting, and cost-effective alternative to surgical correction, he continued.

The study involved 103 middle-aged subjects with a baseline score of 2-5 on the 6-point Mid-Face Volume-Deficit Scale (MVDS). They were corrected to a 0 or 1, meaning no or mild deficit, by means of a baseline injection of up to 2 cc of Voluma per side. This was followed by an additional injection of up to 2 cc per side if needed at week 4. Patients received a mean total volume of 3.1 mL per side. No further retreatment was permitted until week 78.

A greater than 1-point improvement over baseline MVDS was present in 96% of patients at week 8, 90% at week 52, and 84% at week 78. Similarly, 100% of patients had a greater than 1-point improvement on the 5-point Global Aesthetic Improvement Scale (GAIS)at week 8, 92% at week 52, and 82% at week 78. In all, 78% of patients rated themselves as having more than a 1-point improvement on the GAIS at week 78.

At week 78, 32% of patients received a supplemental injection of Voluma, based upon protocol-defined criteria indicating they had returned to within less than 1 MVDS point of their pretreatment midface volume.

The chief side effect of treatment was mild to moderate bruising at the injection site. This was much more common early in the study, when Voluma was new to Australian physicians.

"We were finding our way back then," Dr. Goodman recalled.

The study was sponsored by Allergan. Dr. Goodman is a consultant to the company.

DANA POINT, CALIF. – The rate of granuloma formation following use of Artefill for the correction of nasolabial folds stands at 0.59%, interim results from a 5-year study have shown.

Dr. Christopher B. Zachary presented 36-month results from the prospective study at the SDEF Summit in Aesthetic Medicine. The study was required by the Food and Drug Administration and is the largest and longest prospective clinical study to date for dermal fillers in the United States and in the European Union, according to Dr. Zachary.

The purpose of the study is to assess the safety of Artefill (Suneva Medical) in 1,008 patients, based on the incidence of anticipated and unanticipated adverse events and serious adverse events, the incidence of granuloma formation, and subjects' assessment of satisfaction.

Patients were treated for the correction of nasolabial folds at baseline. They received two touch-up treatments if needed, said Dr. Zachary, professor and chair of the department of dermatology at the University of California, Irvine. The second clinic visit consisted of a clinical evaluation and photos of the treated site 3 months after the last treatment.

Patients filled out questionnaires at 6, 12, and 18 months and at 2 and 3 years, and will again do so at years 4 and 5. Adverse events were reported to the site for investigation. Final visits are scheduled for 5 years after the last Artefill treatment.

The mean age of the 1,008 patients was 54 years, 89% were female, and 88% were white. Most subjects (975) are still in the trial, while 29 have been lost to follow-up or withdrew consent for personal reasons, and four non–treatment-related deaths have occurred.

A total of 114 adverse events deemed device related have occurred to date, for a rate of 11%. These include local complications such as lumpiness, swelling, and redness. In addition, 11 lesions have been identified and biopsied: 4 were viewed as unremarkable at biopsy, 1 was categorized as a foreign body reaction consistent with implant material, and 6 were granulomas, for a rate of 0.59%. Five granulomas resolved completely and one is responding well to treatment.

"You might say that the 0.59% incidence of granulomas is a bit high when you consider that the worldwide reported incidence of granulomas after using Artefill is 0.04%," said Dr. Zachary. "If the FDA required an intense 5-year study of all the commonly used filler products, where every adverse event [AE] was reported, then you would expect the overall AE incidence to be significantly higher. So what is the real incidence of AEs in fillers, and does reliance on voluntary reporting give us misleading results?"

Patient satisfaction scores have remained high over time. For example, at 6 months, 81% reported being "very satisfied" or "satisfied" with the cosmetic results, compared with 79% at 18 months, and 78% at 24 months.

"I'm not up here promoting the product, but I do think Artefill is very safe," Dr. Zachary said. "In practice, this study demonstrates that the product is probably just as safe as hyaluronic acids. Some of my colleagues hate to hear this, and I am not really a fan of permanent fillers, but if we determine that a company needs to perform a comprehensive 5-year safety study, then we need to sit up and take notice of the results. To do otherwise would be ignorant."

Dr. Zachary disclosed that he has received research support, discounts on devices, and honoraria from numerous laser and device companies, including Suneva Medical. He is a member of Suneva’s scientific advisory board.

SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – The rate of granuloma formation following use of Artefill for the correction of nasolabial folds stands at 0.59%, interim results from a 5-year study have shown.

Dr. Christopher B. Zachary presented 36-month results from the prospective study at the SDEF Summit in Aesthetic Medicine. The study was required by the Food and Drug Administration and is the largest and longest prospective clinical study to date for dermal fillers in the United States and in the European Union, according to Dr. Zachary.

The purpose of the study is to assess the safety of Artefill (Suneva Medical) in 1,008 patients, based on the incidence of anticipated and unanticipated adverse events and serious adverse events, the incidence of granuloma formation, and subjects' assessment of satisfaction.

Patients were treated for the correction of nasolabial folds at baseline. They received two touch-up treatments if needed, said Dr. Zachary, professor and chair of the department of dermatology at the University of California, Irvine. The second clinic visit consisted of a clinical evaluation and photos of the treated site 3 months after the last treatment.

Patients filled out questionnaires at 6, 12, and 18 months and at 2 and 3 years, and will again do so at years 4 and 5. Adverse events were reported to the site for investigation. Final visits are scheduled for 5 years after the last Artefill treatment.

The mean age of the 1,008 patients was 54 years, 89% were female, and 88% were white. Most subjects (975) are still in the trial, while 29 have been lost to follow-up or withdrew consent for personal reasons, and four non–treatment-related deaths have occurred.

A total of 114 adverse events deemed device related have occurred to date, for a rate of 11%. These include local complications such as lumpiness, swelling, and redness. In addition, 11 lesions have been identified and biopsied: 4 were viewed as unremarkable at biopsy, 1 was categorized as a foreign body reaction consistent with implant material, and 6 were granulomas, for a rate of 0.59%. Five granulomas resolved completely and one is responding well to treatment.

"You might say that the 0.59% incidence of granulomas is a bit high when you consider that the worldwide reported incidence of granulomas after using Artefill is 0.04%," said Dr. Zachary. "If the FDA required an intense 5-year study of all the commonly used filler products, where every adverse event [AE] was reported, then you would expect the overall AE incidence to be significantly higher. So what is the real incidence of AEs in fillers, and does reliance on voluntary reporting give us misleading results?"

Patient satisfaction scores have remained high over time. For example, at 6 months, 81% reported being "very satisfied" or "satisfied" with the cosmetic results, compared with 79% at 18 months, and 78% at 24 months.

"I'm not up here promoting the product, but I do think Artefill is very safe," Dr. Zachary said. "In practice, this study demonstrates that the product is probably just as safe as hyaluronic acids. Some of my colleagues hate to hear this, and I am not really a fan of permanent fillers, but if we determine that a company needs to perform a comprehensive 5-year safety study, then we need to sit up and take notice of the results. To do otherwise would be ignorant."

Dr. Zachary disclosed that he has received research support, discounts on devices, and honoraria from numerous laser and device companies, including Suneva Medical. He is a member of Suneva’s scientific advisory board.

SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – The rate of granuloma formation following use of Artefill for the correction of nasolabial folds stands at 0.59%, interim results from a 5-year study have shown.

Dr. Christopher B. Zachary presented 36-month results from the prospective study at the SDEF Summit in Aesthetic Medicine. The study was required by the Food and Drug Administration and is the largest and longest prospective clinical study to date for dermal fillers in the United States and in the European Union, according to Dr. Zachary.

The purpose of the study is to assess the safety of Artefill (Suneva Medical) in 1,008 patients, based on the incidence of anticipated and unanticipated adverse events and serious adverse events, the incidence of granuloma formation, and subjects' assessment of satisfaction.

Patients were treated for the correction of nasolabial folds at baseline. They received two touch-up treatments if needed, said Dr. Zachary, professor and chair of the department of dermatology at the University of California, Irvine. The second clinic visit consisted of a clinical evaluation and photos of the treated site 3 months after the last treatment.

Patients filled out questionnaires at 6, 12, and 18 months and at 2 and 3 years, and will again do so at years 4 and 5. Adverse events were reported to the site for investigation. Final visits are scheduled for 5 years after the last Artefill treatment.

The mean age of the 1,008 patients was 54 years, 89% were female, and 88% were white. Most subjects (975) are still in the trial, while 29 have been lost to follow-up or withdrew consent for personal reasons, and four non–treatment-related deaths have occurred.

A total of 114 adverse events deemed device related have occurred to date, for a rate of 11%. These include local complications such as lumpiness, swelling, and redness. In addition, 11 lesions have been identified and biopsied: 4 were viewed as unremarkable at biopsy, 1 was categorized as a foreign body reaction consistent with implant material, and 6 were granulomas, for a rate of 0.59%. Five granulomas resolved completely and one is responding well to treatment.

"You might say that the 0.59% incidence of granulomas is a bit high when you consider that the worldwide reported incidence of granulomas after using Artefill is 0.04%," said Dr. Zachary. "If the FDA required an intense 5-year study of all the commonly used filler products, where every adverse event [AE] was reported, then you would expect the overall AE incidence to be significantly higher. So what is the real incidence of AEs in fillers, and does reliance on voluntary reporting give us misleading results?"

Patient satisfaction scores have remained high over time. For example, at 6 months, 81% reported being "very satisfied" or "satisfied" with the cosmetic results, compared with 79% at 18 months, and 78% at 24 months.

"I'm not up here promoting the product, but I do think Artefill is very safe," Dr. Zachary said. "In practice, this study demonstrates that the product is probably just as safe as hyaluronic acids. Some of my colleagues hate to hear this, and I am not really a fan of permanent fillers, but if we determine that a company needs to perform a comprehensive 5-year safety study, then we need to sit up and take notice of the results. To do otherwise would be ignorant."

Dr. Zachary disclosed that he has received research support, discounts on devices, and honoraria from numerous laser and device companies, including Suneva Medical. He is a member of Suneva’s scientific advisory board.

SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – Before undergoing facial fat augmentation, patients routinely ask Dr. Jonathan M. Sykes how long their results will last.

"I tell them that the longevity of fat is variable in different parts of the face," Dr. Sykes said at the. Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF). He described long-term results in the infraorbital region, the malar region, and the tear trough as "great"; in the melolabial fold and pre-jowl sulcus as "good"; and in the lips as "not so good."

"I think lips are the hardest area to treat," said Dr. Sykes, director of facial plastic and reconstructive surgery at the University of California Davis Health System, Sacramento.

One advantage of facial fat augmentation is that most patients have an abundant supply of autologous fat, with the exception of bodybuilders and patients who have been on long-term antiretroviral medicines for HIV, he said. "It’s also easy to perform simultaneously with other surgical rejuvenative procedures, and it does not add significantly to time or cost. I harvest the fat at the beginning, and put it in at the end. Other physicians put in the fat right away and then do the surgical procedure."

Disadvantages of facial fat augmentation, he said, are that the procedure is time and technique sensitive, donor site contour irregularities are possible, donor site pain/ecchymosis is possible, and it is difficult to modulate the results.

Instruments he uses for most procedures include four cannulas made by San Diego–based Tulip Medical: a 0.9-mm spoon tip cannula that is 4 cm long for periorbital injections, a 1.2-mm spoon tip cannula that’s 6 cm long for all-purpose injections, a 3.0-mm bullet tip cannula that is 15 cm long for all-purpose fat harvesting, and a 2.1-mm multiport cannula that is 12 cm long and used as an optional secondary cannula for thin patients.

Dr. Sykes, who is also the current president of the American Academy of Facial Plastic and Reconstructive Surgery, said he prefers the upper/outer hip as a donor source, but makes it a point to ask patients where they retain the most fat. "In women, usually it’s the abdomen, hips, and inner/outer thighs, while in men it’s usually the abdomen or the hips," he said. "There is some evidence that outer thigh fat persists a bit better because it’s less vascular."

To harvest the fat he uses four to eight 10-cc Luer lock syringes with low negative pressure. He then stands the syringes upright for about 15 minutes, "typically while other surgical procedures are being performed," he said.

Next, he places the fat into a centrifuge at 3,000 rpm for 1-3 minutes and transfers the fat into one 20- or 35-cc syringe. He uses a Leur lock transfer hub to transfer the fat into several 1-cc Leur lock syringes.

Dr. Sykes said he routinely uses local anesthesia with epinephrine 20 minutes prior to injection. "That gives us less bleeding and less ecchymosis," he said.

He then injects small parcels of fat as the cannula is withdrawn, aiming for 30-50 passes per 1 cc of fat.

In most patients, adding fat volume to the face "creates a rejuvenated, youthful appearance," Dr. Sykes concluded, noting that he performs fat augmentation in about 70% of face-lift procedures.

Dr. Sykes disclosed that he has served as a paid trainer and speaker for Sanofi Aventis and Medicis.

SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – Before undergoing facial fat augmentation, patients routinely ask Dr. Jonathan M. Sykes how long their results will last.

"I tell them that the longevity of fat is variable in different parts of the face," Dr. Sykes said at the. Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF). He described long-term results in the infraorbital region, the malar region, and the tear trough as "great"; in the melolabial fold and pre-jowl sulcus as "good"; and in the lips as "not so good."

"I think lips are the hardest area to treat," said Dr. Sykes, director of facial plastic and reconstructive surgery at the University of California Davis Health System, Sacramento.

One advantage of facial fat augmentation is that most patients have an abundant supply of autologous fat, with the exception of bodybuilders and patients who have been on long-term antiretroviral medicines for HIV, he said. "It’s also easy to perform simultaneously with other surgical rejuvenative procedures, and it does not add significantly to time or cost. I harvest the fat at the beginning, and put it in at the end. Other physicians put in the fat right away and then do the surgical procedure."

Disadvantages of facial fat augmentation, he said, are that the procedure is time and technique sensitive, donor site contour irregularities are possible, donor site pain/ecchymosis is possible, and it is difficult to modulate the results.

Instruments he uses for most procedures include four cannulas made by San Diego–based Tulip Medical: a 0.9-mm spoon tip cannula that is 4 cm long for periorbital injections, a 1.2-mm spoon tip cannula that’s 6 cm long for all-purpose injections, a 3.0-mm bullet tip cannula that is 15 cm long for all-purpose fat harvesting, and a 2.1-mm multiport cannula that is 12 cm long and used as an optional secondary cannula for thin patients.

Dr. Sykes, who is also the current president of the American Academy of Facial Plastic and Reconstructive Surgery, said he prefers the upper/outer hip as a donor source, but makes it a point to ask patients where they retain the most fat. "In women, usually it’s the abdomen, hips, and inner/outer thighs, while in men it’s usually the abdomen or the hips," he said. "There is some evidence that outer thigh fat persists a bit better because it’s less vascular."

To harvest the fat he uses four to eight 10-cc Luer lock syringes with low negative pressure. He then stands the syringes upright for about 15 minutes, "typically while other surgical procedures are being performed," he said.

Next, he places the fat into a centrifuge at 3,000 rpm for 1-3 minutes and transfers the fat into one 20- or 35-cc syringe. He uses a Leur lock transfer hub to transfer the fat into several 1-cc Leur lock syringes.

Dr. Sykes said he routinely uses local anesthesia with epinephrine 20 minutes prior to injection. "That gives us less bleeding and less ecchymosis," he said.

He then injects small parcels of fat as the cannula is withdrawn, aiming for 30-50 passes per 1 cc of fat.

In most patients, adding fat volume to the face "creates a rejuvenated, youthful appearance," Dr. Sykes concluded, noting that he performs fat augmentation in about 70% of face-lift procedures.

Dr. Sykes disclosed that he has served as a paid trainer and speaker for Sanofi Aventis and Medicis.

SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – Before undergoing facial fat augmentation, patients routinely ask Dr. Jonathan M. Sykes how long their results will last.

"I tell them that the longevity of fat is variable in different parts of the face," Dr. Sykes said at the. Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF). He described long-term results in the infraorbital region, the malar region, and the tear trough as "great"; in the melolabial fold and pre-jowl sulcus as "good"; and in the lips as "not so good."

"I think lips are the hardest area to treat," said Dr. Sykes, director of facial plastic and reconstructive surgery at the University of California Davis Health System, Sacramento.

One advantage of facial fat augmentation is that most patients have an abundant supply of autologous fat, with the exception of bodybuilders and patients who have been on long-term antiretroviral medicines for HIV, he said. "It’s also easy to perform simultaneously with other surgical rejuvenative procedures, and it does not add significantly to time or cost. I harvest the fat at the beginning, and put it in at the end. Other physicians put in the fat right away and then do the surgical procedure."

Disadvantages of facial fat augmentation, he said, are that the procedure is time and technique sensitive, donor site contour irregularities are possible, donor site pain/ecchymosis is possible, and it is difficult to modulate the results.

Instruments he uses for most procedures include four cannulas made by San Diego–based Tulip Medical: a 0.9-mm spoon tip cannula that is 4 cm long for periorbital injections, a 1.2-mm spoon tip cannula that’s 6 cm long for all-purpose injections, a 3.0-mm bullet tip cannula that is 15 cm long for all-purpose fat harvesting, and a 2.1-mm multiport cannula that is 12 cm long and used as an optional secondary cannula for thin patients.

Dr. Sykes, who is also the current president of the American Academy of Facial Plastic and Reconstructive Surgery, said he prefers the upper/outer hip as a donor source, but makes it a point to ask patients where they retain the most fat. "In women, usually it’s the abdomen, hips, and inner/outer thighs, while in men it’s usually the abdomen or the hips," he said. "There is some evidence that outer thigh fat persists a bit better because it’s less vascular."

To harvest the fat he uses four to eight 10-cc Luer lock syringes with low negative pressure. He then stands the syringes upright for about 15 minutes, "typically while other surgical procedures are being performed," he said.

Next, he places the fat into a centrifuge at 3,000 rpm for 1-3 minutes and transfers the fat into one 20- or 35-cc syringe. He uses a Leur lock transfer hub to transfer the fat into several 1-cc Leur lock syringes.

Dr. Sykes said he routinely uses local anesthesia with epinephrine 20 minutes prior to injection. "That gives us less bleeding and less ecchymosis," he said.

He then injects small parcels of fat as the cannula is withdrawn, aiming for 30-50 passes per 1 cc of fat.

In most patients, adding fat volume to the face "creates a rejuvenated, youthful appearance," Dr. Sykes concluded, noting that he performs fat augmentation in about 70% of face-lift procedures.

Dr. Sykes disclosed that he has served as a paid trainer and speaker for Sanofi Aventis and Medicis.

SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – In the opinion of Dr. Gordon Sasaki, laser-assisted liposuction is still "finding its place" as a treatment option for invasive body shaping.

"We have to keep in mind that gold standard still is traditional liposuction," Dr. Sasaki said at the Summit in Aesthetic Medicine, sponsored by Skin Disease Education Foundation (SDEF). "Any other types of devices that come on the market have to be measured against that."

While there are currently six devices cleared by the Food and Drug Administration for laser-assisted liposuction, Dr. Sasaki discussed the one he has the most experience with: Cynosure's Smartlipo, which contains a laser that fires at three wavelengths: 1,064 nm, 1,320 nm, and 1,440 nm.

"I believe that the primary effect of laser lipolysis is collagen for tissue contraction, more than skin accommodation, redistribution, or retraction," said Dr. Sasaki, clinical professor of plastic surgery at Loma Linda (Calif.) University. "I think the secondary effect is lipolysis."

Since June 2008, Dr. Sasaki has treated 252 patients with Smartlipo. Their average age was 48 years, 91% were female, and their average body mass index was 24.9 kg/m². Per case, the average total infiltrate was about 2,500 cc, the average total aspirate was about 2,400 cc, and the average total amount of fat removed was about 2,000 cc.

"That means the average fat/aspirate ratio is 87%, which is comparable to other liposuction methods," said Dr. Sasaki, who has a private aesthetic plastic surgery practice in Pasadena, Calif.

Preoperative medications include 5-10 mg of diazepam or Norco 10/325 as needed. After making 5-by-5-cm preoperative markings in the skin, he delivers 50-100 cc per 5-by-5-cm² of tumescent anesthesia to the treatment area. Next, he delivers deep laser energy to the skin. For example, his protocol for the 1440-nm laser is to deliver 1,000-1,500 J per 5-by-5-cm² to the body area and 200-500 J per 5-by-5-cm² to the face.

The next step involves liposuction, which enables "a better clinical assessment of the contouring," he explained. "You remove all of that debris, so when you bring in the heating for the subdermis of the skin the process goes much faster because you don’t have to heat up the materials that you have already destroyed."

This is followed by shallow laser-assisted liposuction "where the skin is heated in a controlled fashion to 38-42  C," Dr. Sasaki said. "At this time, I use either the 1,440-nm laser or a combination of the 1,064-nm and 1,320-nm, depending upon its usages either for the skin of the facial area or to other parts of the body."

For postoperative management, he uses quarter-inch Penrose drains, which are removed the day after the procedure.

"I use compression garments as long as the patients can tolerate them, usually for 1 or 2 weeks," he said. He also uses external ultrasound treatment to smooth out the areas of lymphatic drainage and light-emitting diode skin rejuvenation sessions for inflammation.

Dr. Sasaki said that off-label uses of laser-assisted liposuction "are beginning to be investigated to expand its potential therapies in other areas, especially cellulite."

Dr. Sasaki disclosed that he has been a paid consultant for many laser and device companies, including Cynosure.

SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – In the opinion of Dr. Gordon Sasaki, laser-assisted liposuction is still "finding its place" as a treatment option for invasive body shaping.

"We have to keep in mind that gold standard still is traditional liposuction," Dr. Sasaki said at the Summit in Aesthetic Medicine, sponsored by Skin Disease Education Foundation (SDEF). "Any other types of devices that come on the market have to be measured against that."

While there are currently six devices cleared by the Food and Drug Administration for laser-assisted liposuction, Dr. Sasaki discussed the one he has the most experience with: Cynosure's Smartlipo, which contains a laser that fires at three wavelengths: 1,064 nm, 1,320 nm, and 1,440 nm.

"I believe that the primary effect of laser lipolysis is collagen for tissue contraction, more than skin accommodation, redistribution, or retraction," said Dr. Sasaki, clinical professor of plastic surgery at Loma Linda (Calif.) University. "I think the secondary effect is lipolysis."

Since June 2008, Dr. Sasaki has treated 252 patients with Smartlipo. Their average age was 48 years, 91% were female, and their average body mass index was 24.9 kg/m². Per case, the average total infiltrate was about 2,500 cc, the average total aspirate was about 2,400 cc, and the average total amount of fat removed was about 2,000 cc.

"That means the average fat/aspirate ratio is 87%, which is comparable to other liposuction methods," said Dr. Sasaki, who has a private aesthetic plastic surgery practice in Pasadena, Calif.

Preoperative medications include 5-10 mg of diazepam or Norco 10/325 as needed. After making 5-by-5-cm preoperative markings in the skin, he delivers 50-100 cc per 5-by-5-cm² of tumescent anesthesia to the treatment area. Next, he delivers deep laser energy to the skin. For example, his protocol for the 1440-nm laser is to deliver 1,000-1,500 J per 5-by-5-cm² to the body area and 200-500 J per 5-by-5-cm² to the face.

The next step involves liposuction, which enables "a better clinical assessment of the contouring," he explained. "You remove all of that debris, so when you bring in the heating for the subdermis of the skin the process goes much faster because you don’t have to heat up the materials that you have already destroyed."

This is followed by shallow laser-assisted liposuction "where the skin is heated in a controlled fashion to 38-42  C," Dr. Sasaki said. "At this time, I use either the 1,440-nm laser or a combination of the 1,064-nm and 1,320-nm, depending upon its usages either for the skin of the facial area or to other parts of the body."

For postoperative management, he uses quarter-inch Penrose drains, which are removed the day after the procedure.

"I use compression garments as long as the patients can tolerate them, usually for 1 or 2 weeks," he said. He also uses external ultrasound treatment to smooth out the areas of lymphatic drainage and light-emitting diode skin rejuvenation sessions for inflammation.

Dr. Sasaki said that off-label uses of laser-assisted liposuction "are beginning to be investigated to expand its potential therapies in other areas, especially cellulite."

Dr. Sasaki disclosed that he has been a paid consultant for many laser and device companies, including Cynosure.

SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – In the opinion of Dr. Gordon Sasaki, laser-assisted liposuction is still "finding its place" as a treatment option for invasive body shaping.

"We have to keep in mind that gold standard still is traditional liposuction," Dr. Sasaki said at the Summit in Aesthetic Medicine, sponsored by Skin Disease Education Foundation (SDEF). "Any other types of devices that come on the market have to be measured against that."

While there are currently six devices cleared by the Food and Drug Administration for laser-assisted liposuction, Dr. Sasaki discussed the one he has the most experience with: Cynosure's Smartlipo, which contains a laser that fires at three wavelengths: 1,064 nm, 1,320 nm, and 1,440 nm.

"I believe that the primary effect of laser lipolysis is collagen for tissue contraction, more than skin accommodation, redistribution, or retraction," said Dr. Sasaki, clinical professor of plastic surgery at Loma Linda (Calif.) University. "I think the secondary effect is lipolysis."

Since June 2008, Dr. Sasaki has treated 252 patients with Smartlipo. Their average age was 48 years, 91% were female, and their average body mass index was 24.9 kg/m². Per case, the average total infiltrate was about 2,500 cc, the average total aspirate was about 2,400 cc, and the average total amount of fat removed was about 2,000 cc.

"That means the average fat/aspirate ratio is 87%, which is comparable to other liposuction methods," said Dr. Sasaki, who has a private aesthetic plastic surgery practice in Pasadena, Calif.

Preoperative medications include 5-10 mg of diazepam or Norco 10/325 as needed. After making 5-by-5-cm preoperative markings in the skin, he delivers 50-100 cc per 5-by-5-cm² of tumescent anesthesia to the treatment area. Next, he delivers deep laser energy to the skin. For example, his protocol for the 1440-nm laser is to deliver 1,000-1,500 J per 5-by-5-cm² to the body area and 200-500 J per 5-by-5-cm² to the face.

The next step involves liposuction, which enables "a better clinical assessment of the contouring," he explained. "You remove all of that debris, so when you bring in the heating for the subdermis of the skin the process goes much faster because you don’t have to heat up the materials that you have already destroyed."

This is followed by shallow laser-assisted liposuction "where the skin is heated in a controlled fashion to 38-42  C," Dr. Sasaki said. "At this time, I use either the 1,440-nm laser or a combination of the 1,064-nm and 1,320-nm, depending upon its usages either for the skin of the facial area or to other parts of the body."

For postoperative management, he uses quarter-inch Penrose drains, which are removed the day after the procedure.

"I use compression garments as long as the patients can tolerate them, usually for 1 or 2 weeks," he said. He also uses external ultrasound treatment to smooth out the areas of lymphatic drainage and light-emitting diode skin rejuvenation sessions for inflammation.

Dr. Sasaki said that off-label uses of laser-assisted liposuction "are beginning to be investigated to expand its potential therapies in other areas, especially cellulite."

Dr. Sasaki disclosed that he has been a paid consultant for many laser and device companies, including Cynosure.

SDEF and this news organization are owned by Elsevier.

SEOUL, SOUTH KOREA – Steam ablation of varicose veins appears to be a safe, effective, and relatively simple new endovascular thermal therapy with excellent patient acceptance, according to Dr. Martino Neumann.

"Maybe water will be the future for your practice," said Dr. Neumann. He presented the results of a pilot study of steam ablation at the World Congress of Dermatology.

Steam may offer a safer alternative to endovascular laser ablation of saphenous varicose veins. "If you look at your laser probe after treating a vessel, you can see strong carbonization and slight damage to the tip of the probe. This foreign material may stay within the body," said Dr. Neumann of Erasmus University Medical Center, Rotterdam, the Netherlands.

Endovascular laser ablation of varicose veins has become a popular procedure in recent years. But it results in temperatures of 600°-1,000° degrees C, causing blood to literally boil and carbonize. In contrast, steam ablation is performed at a temperature of 120° C. The pulsed steam is released under pressure into the blood vessel through two holes near the tip.

Steam ablation utilizes a 1.2-mm highly flexible catheter which is introduced directly through the puncturing needle without need for a sheath or guidewire. This makes for a simpler and safer procedure than with the stiff glass fibers used in laser ablation, said Dr. Neumann.

The pilot study entailed steam ablation of 17 great saphenous veins and 3 small saphenous veins in 19 patients. The mean treated vessel length was 25 cm, with an average of 50 steam pulses or puffs administered per treated vein. Each treated vein utilized roughly 2 mL of sterile water. The procedure was conducted on an outpatient basis under local tumescent anesthesia.

Nine patients had ecchymoses at the puncture site, and one had a transient superficial phlebitis. There were no cases of deep vein thrombosis, infection, or any other serious side effects.

All treated veins were occluded upon ultrasound examination 1 week post treatment. At 6 months follow-up, ultrasound examination showed 13 of 20 veins were completely occluded; the other 7 showed a small segment of recanalization that was not clinically relevant.

The investigators continue to search for the optimal dose of steam, expressed as puffs per treated centimeter of vein, to eliminate any recanalization.

Median patient satisfaction with the treatment was 9.25 on a 0-10 scale. Median maximal pain after the procedure was 1 on a 10-point scale.

Based upon the favorable pilot study results, a definitive head-to-head comparative study is underway. Approximately 250 patients at three Dutch medical centers were randomized to steam ablation or laser ablation; participants are now in the follow-up phase of the trial.

Studies in sheep demonstrated that the mechanism of steam ablation involves endothelial destruction, thickening of the vessel wall with fibrosis and inflammation, and alteration of collagen and elastic fibers in the media. The diameter of treated vessels decreased over time, with a mean 56% reduction 3 months post treatment.

If steam ablation is to make substantial inroads on endovascular laser ablation, it will have to be on the basis of safety, cost, and patient and operator satisfaction. Laser ablation is tough to beat on the basis of efficacy.

In a meta-analysis carried out by Dr. Neumann and coinvestigators, the 5-year success rate with endovascular laser ablation of saphenous varicose veins was 95%, compared with 80% for nonsegmental radiofrequency ablation, 74% with ultrasound-guided foam sclerotherapy, and 76% with traditional surgery involving ligation and stripping of the veins.

The steam ablation studies were conducted using the Steam Vein Sclerosis, or SVS, system manufactured by CERMA, a French company. Dr. Neumann declared having no relevant financial relationships.

SEOUL, SOUTH KOREA – Steam ablation of varicose veins appears to be a safe, effective, and relatively simple new endovascular thermal therapy with excellent patient acceptance, according to Dr. Martino Neumann.

"Maybe water will be the future for your practice," said Dr. Neumann. He presented the results of a pilot study of steam ablation at the World Congress of Dermatology.

Steam may offer a safer alternative to endovascular laser ablation of saphenous varicose veins. "If you look at your laser probe after treating a vessel, you can see strong carbonization and slight damage to the tip of the probe. This foreign material may stay within the body," said Dr. Neumann of Erasmus University Medical Center, Rotterdam, the Netherlands.

Endovascular laser ablation of varicose veins has become a popular procedure in recent years. But it results in temperatures of 600°-1,000° degrees C, causing blood to literally boil and carbonize. In contrast, steam ablation is performed at a temperature of 120° C. The pulsed steam is released under pressure into the blood vessel through two holes near the tip.

Steam ablation utilizes a 1.2-mm highly flexible catheter which is introduced directly through the puncturing needle without need for a sheath or guidewire. This makes for a simpler and safer procedure than with the stiff glass fibers used in laser ablation, said Dr. Neumann.

The pilot study entailed steam ablation of 17 great saphenous veins and 3 small saphenous veins in 19 patients. The mean treated vessel length was 25 cm, with an average of 50 steam pulses or puffs administered per treated vein. Each treated vein utilized roughly 2 mL of sterile water. The procedure was conducted on an outpatient basis under local tumescent anesthesia.

Nine patients had ecchymoses at the puncture site, and one had a transient superficial phlebitis. There were no cases of deep vein thrombosis, infection, or any other serious side effects.

All treated veins were occluded upon ultrasound examination 1 week post treatment. At 6 months follow-up, ultrasound examination showed 13 of 20 veins were completely occluded; the other 7 showed a small segment of recanalization that was not clinically relevant.

The investigators continue to search for the optimal dose of steam, expressed as puffs per treated centimeter of vein, to eliminate any recanalization.

Median patient satisfaction with the treatment was 9.25 on a 0-10 scale. Median maximal pain after the procedure was 1 on a 10-point scale.

Based upon the favorable pilot study results, a definitive head-to-head comparative study is underway. Approximately 250 patients at three Dutch medical centers were randomized to steam ablation or laser ablation; participants are now in the follow-up phase of the trial.

Studies in sheep demonstrated that the mechanism of steam ablation involves endothelial destruction, thickening of the vessel wall with fibrosis and inflammation, and alteration of collagen and elastic fibers in the media. The diameter of treated vessels decreased over time, with a mean 56% reduction 3 months post treatment.

If steam ablation is to make substantial inroads on endovascular laser ablation, it will have to be on the basis of safety, cost, and patient and operator satisfaction. Laser ablation is tough to beat on the basis of efficacy.

In a meta-analysis carried out by Dr. Neumann and coinvestigators, the 5-year success rate with endovascular laser ablation of saphenous varicose veins was 95%, compared with 80% for nonsegmental radiofrequency ablation, 74% with ultrasound-guided foam sclerotherapy, and 76% with traditional surgery involving ligation and stripping of the veins.

The steam ablation studies were conducted using the Steam Vein Sclerosis, or SVS, system manufactured by CERMA, a French company. Dr. Neumann declared having no relevant financial relationships.

SEOUL, SOUTH KOREA – Steam ablation of varicose veins appears to be a safe, effective, and relatively simple new endovascular thermal therapy with excellent patient acceptance, according to Dr. Martino Neumann.

"Maybe water will be the future for your practice," said Dr. Neumann. He presented the results of a pilot study of steam ablation at the World Congress of Dermatology.

Steam may offer a safer alternative to endovascular laser ablation of saphenous varicose veins. "If you look at your laser probe after treating a vessel, you can see strong carbonization and slight damage to the tip of the probe. This foreign material may stay within the body," said Dr. Neumann of Erasmus University Medical Center, Rotterdam, the Netherlands.

Endovascular laser ablation of varicose veins has become a popular procedure in recent years. But it results in temperatures of 600°-1,000° degrees C, causing blood to literally boil and carbonize. In contrast, steam ablation is performed at a temperature of 120° C. The pulsed steam is released under pressure into the blood vessel through two holes near the tip.

Steam ablation utilizes a 1.2-mm highly flexible catheter which is introduced directly through the puncturing needle without need for a sheath or guidewire. This makes for a simpler and safer procedure than with the stiff glass fibers used in laser ablation, said Dr. Neumann.

The pilot study entailed steam ablation of 17 great saphenous veins and 3 small saphenous veins in 19 patients. The mean treated vessel length was 25 cm, with an average of 50 steam pulses or puffs administered per treated vein. Each treated vein utilized roughly 2 mL of sterile water. The procedure was conducted on an outpatient basis under local tumescent anesthesia.

Nine patients had ecchymoses at the puncture site, and one had a transient superficial phlebitis. There were no cases of deep vein thrombosis, infection, or any other serious side effects.

All treated veins were occluded upon ultrasound examination 1 week post treatment. At 6 months follow-up, ultrasound examination showed 13 of 20 veins were completely occluded; the other 7 showed a small segment of recanalization that was not clinically relevant.

The investigators continue to search for the optimal dose of steam, expressed as puffs per treated centimeter of vein, to eliminate any recanalization.

Median patient satisfaction with the treatment was 9.25 on a 0-10 scale. Median maximal pain after the procedure was 1 on a 10-point scale.

Based upon the favorable pilot study results, a definitive head-to-head comparative study is underway. Approximately 250 patients at three Dutch medical centers were randomized to steam ablation or laser ablation; participants are now in the follow-up phase of the trial.

Studies in sheep demonstrated that the mechanism of steam ablation involves endothelial destruction, thickening of the vessel wall with fibrosis and inflammation, and alteration of collagen and elastic fibers in the media. The diameter of treated vessels decreased over time, with a mean 56% reduction 3 months post treatment.

If steam ablation is to make substantial inroads on endovascular laser ablation, it will have to be on the basis of safety, cost, and patient and operator satisfaction. Laser ablation is tough to beat on the basis of efficacy.

In a meta-analysis carried out by Dr. Neumann and coinvestigators, the 5-year success rate with endovascular laser ablation of saphenous varicose veins was 95%, compared with 80% for nonsegmental radiofrequency ablation, 74% with ultrasound-guided foam sclerotherapy, and 76% with traditional surgery involving ligation and stripping of the veins.

The steam ablation studies were conducted using the Steam Vein Sclerosis, or SVS, system manufactured by CERMA, a French company. Dr. Neumann declared having no relevant financial relationships.

GRAPEVINE, TEX. – High-intensity focused ultrasound body contouring was both objectively and subjectively superior to sham treatment for reducing waist circumference in a randomized controlled trial of 180 adults who sought removal of excess abdominal fat.

"High-intensity focused ultrasound is a noninvasive, effective, and well-tolerated option for body contouring," said Dr. Jeremy B. Green of Skin Care Physicians, Chestnut Hill, Mass.

The patients were enrolled at nine clinical sites. They were aged 18-65 years, with subcutaneous abdominal adipose tissue depth of 2.5 cm or greater but with body mass indexes no greater than 30 kg/m².

The majority (80%) were white women, with an average weight of 70 kg and BMI of approximately 25 kg/m². They were randomized to one of three groups: a "low-energy" HIFU dose of 141 J/cm² (three passes of 47 J/cm²), a "high-energy" dose of 177 J/cm² (three passes of 59 J/cm²), or a sham control using three passes with 0 J/cm².

The primary outcome was mean change from baseline waist circumference at 12 weeks post treatment.

In the per protocol population of 168 patients, there were significantly greater least squares mean reductions of 2.5 cm with the high-energy treatment and 2.1 cm with the low-energy treatment, compared with a drop of 1.2 cm in the sham group. (Subjects had agreed not to change their diet or exercise.)

There were also significantly greater waist circumference reductions for the high-energy HIFU at 4 weeks (1.8 cm vs. 0.2 cm with sham) and for both energy levels at week 8 (2.6 cm with high-energy and 2.6 cm with low-energy vs. 0.9 cm with sham).

Significance was achieved for the primary outcome with the high-energy treatment and some of the secondary outcomes in the intent-to-treat population of all 180 enrolled patients, he noted.

Subjective aesthetic assessments by both investigators and patients were consistent with the primary outcome measure. Investigator Global Aesthetic Improvement Scale (GAIS) ratings were significantly improved compared with sham treatments for both energy levels at weeks 4-8.

At 8 weeks, investigators deemed two-thirds of the patients as "much improved" or "improved" with both high- and low-energy HIFU, compared with just 19% for sham treatment, Dr. Green reported.

On patient satisfaction questionnaires, 58% treated with the low-energy and 67% with high-energy HIFU reported being "satisfied" or "very satisfied" at week 12, compared with 48% of those who received sham treatment. The difference was statistically significant for the high-energy HIFU.

Adverse events included pain during and after the procedure, ecchymosis, and edema. Six of the 180 enrolled patients did not complete the treatment because of pain. However, more than two-thirds of each group reported just mild or no pain, and all resolved by 16 days.

Half of the active treatment patients had mild bruising, all of which resolved in 10-14 days. There were no unanticipated adverse events. Clinical laboratory tests did not reveal any abnormalities or fluctuations with regard to lipid profiles, markers of inflammation, coagulation, hepatic or renal function, hematologic assessments, or blood chemistry, he reported.

Patients were compliant in maintaining their pretreatment diet and exercise habits, and there were minimal weight fluctuations during the study.

GRAPEVINE, TEX. – High-intensity focused ultrasound body contouring was both objectively and subjectively superior to sham treatment for reducing waist circumference in a randomized controlled trial of 180 adults who sought removal of excess abdominal fat.

"High-intensity focused ultrasound is a noninvasive, effective, and well-tolerated option for body contouring," said Dr. Jeremy B. Green of Skin Care Physicians, Chestnut Hill, Mass.

The patients were enrolled at nine clinical sites. They were aged 18-65 years, with subcutaneous abdominal adipose tissue depth of 2.5 cm or greater but with body mass indexes no greater than 30 kg/m².

The majority (80%) were white women, with an average weight of 70 kg and BMI of approximately 25 kg/m². They were randomized to one of three groups: a "low-energy" HIFU dose of 141 J/cm² (three passes of 47 J/cm²), a "high-energy" dose of 177 J/cm² (three passes of 59 J/cm²), or a sham control using three passes with 0 J/cm².

The primary outcome was mean change from baseline waist circumference at 12 weeks post treatment.

In the per protocol population of 168 patients, there were significantly greater least squares mean reductions of 2.5 cm with the high-energy treatment and 2.1 cm with the low-energy treatment, compared with a drop of 1.2 cm in the sham group. (Subjects had agreed not to change their diet or exercise.)

There were also significantly greater waist circumference reductions for the high-energy HIFU at 4 weeks (1.8 cm vs. 0.2 cm with sham) and for both energy levels at week 8 (2.6 cm with high-energy and 2.6 cm with low-energy vs. 0.9 cm with sham).

Significance was achieved for the primary outcome with the high-energy treatment and some of the secondary outcomes in the intent-to-treat population of all 180 enrolled patients, he noted.

Subjective aesthetic assessments by both investigators and patients were consistent with the primary outcome measure. Investigator Global Aesthetic Improvement Scale (GAIS) ratings were significantly improved compared with sham treatments for both energy levels at weeks 4-8.

At 8 weeks, investigators deemed two-thirds of the patients as "much improved" or "improved" with both high- and low-energy HIFU, compared with just 19% for sham treatment, Dr. Green reported.

On patient satisfaction questionnaires, 58% treated with the low-energy and 67% with high-energy HIFU reported being "satisfied" or "very satisfied" at week 12, compared with 48% of those who received sham treatment. The difference was statistically significant for the high-energy HIFU.

Adverse events included pain during and after the procedure, ecchymosis, and edema. Six of the 180 enrolled patients did not complete the treatment because of pain. However, more than two-thirds of each group reported just mild or no pain, and all resolved by 16 days.

Half of the active treatment patients had mild bruising, all of which resolved in 10-14 days. There were no unanticipated adverse events. Clinical laboratory tests did not reveal any abnormalities or fluctuations with regard to lipid profiles, markers of inflammation, coagulation, hepatic or renal function, hematologic assessments, or blood chemistry, he reported.

Patients were compliant in maintaining their pretreatment diet and exercise habits, and there were minimal weight fluctuations during the study.

GRAPEVINE, TEX. – High-intensity focused ultrasound body contouring was both objectively and subjectively superior to sham treatment for reducing waist circumference in a randomized controlled trial of 180 adults who sought removal of excess abdominal fat.

"High-intensity focused ultrasound is a noninvasive, effective, and well-tolerated option for body contouring," said Dr. Jeremy B. Green of Skin Care Physicians, Chestnut Hill, Mass.

The patients were enrolled at nine clinical sites. They were aged 18-65 years, with subcutaneous abdominal adipose tissue depth of 2.5 cm or greater but with body mass indexes no greater than 30 kg/m².

The majority (80%) were white women, with an average weight of 70 kg and BMI of approximately 25 kg/m². They were randomized to one of three groups: a "low-energy" HIFU dose of 141 J/cm² (three passes of 47 J/cm²), a "high-energy" dose of 177 J/cm² (three passes of 59 J/cm²), or a sham control using three passes with 0 J/cm².

The primary outcome was mean change from baseline waist circumference at 12 weeks post treatment.

In the per protocol population of 168 patients, there were significantly greater least squares mean reductions of 2.5 cm with the high-energy treatment and 2.1 cm with the low-energy treatment, compared with a drop of 1.2 cm in the sham group. (Subjects had agreed not to change their diet or exercise.)

There were also significantly greater waist circumference reductions for the high-energy HIFU at 4 weeks (1.8 cm vs. 0.2 cm with sham) and for both energy levels at week 8 (2.6 cm with high-energy and 2.6 cm with low-energy vs. 0.9 cm with sham).

Significance was achieved for the primary outcome with the high-energy treatment and some of the secondary outcomes in the intent-to-treat population of all 180 enrolled patients, he noted.

Subjective aesthetic assessments by both investigators and patients were consistent with the primary outcome measure. Investigator Global Aesthetic Improvement Scale (GAIS) ratings were significantly improved compared with sham treatments for both energy levels at weeks 4-8.

At 8 weeks, investigators deemed two-thirds of the patients as "much improved" or "improved" with both high- and low-energy HIFU, compared with just 19% for sham treatment, Dr. Green reported.

On patient satisfaction questionnaires, 58% treated with the low-energy and 67% with high-energy HIFU reported being "satisfied" or "very satisfied" at week 12, compared with 48% of those who received sham treatment. The difference was statistically significant for the high-energy HIFU.

Adverse events included pain during and after the procedure, ecchymosis, and edema. Six of the 180 enrolled patients did not complete the treatment because of pain. However, more than two-thirds of each group reported just mild or no pain, and all resolved by 16 days.

Half of the active treatment patients had mild bruising, all of which resolved in 10-14 days. There were no unanticipated adverse events. Clinical laboratory tests did not reveal any abnormalities or fluctuations with regard to lipid profiles, markers of inflammation, coagulation, hepatic or renal function, hematologic assessments, or blood chemistry, he reported.

Patients were compliant in maintaining their pretreatment diet and exercise habits, and there were minimal weight fluctuations during the study.

BOSTON – Skin wrinkling and rigidity could give physicians a clue to bone mineral density, at least among early postmenopausal women, based on a study presented as a poster at the annual meeting of the Endocrine Society.

"In the women that we're talking about, skin wrinkling and skin rigidity – features that are easily appreciable across the table when you are looking at the patient – tie in with bone mineral density as assessed by clinical gold standards, such a as dual x-ray absorptiometry," Dr. Lubna Pal said during a press conference at the meeting.

The researchers explored possible relationships between skin wrinkling/rigidity and bone mineral density (BMD) in a cohort of early menopausal women who were enrolled in the Kronos Early Estrogen Prevention Study, a longitudinal trial of menopausal hormone therapy.

The skin ancillary study to the ongoing Kronos clinical trial included 114 women who had their last menstrual period within the past 3 years. Most of the participants were white, although 30% were not. Cross-sectional baseline data were used, said Dr. Pal, who is a reproductive endocrinologist at Yale University, New Haven, Conn.

Skin wrinkles were assessed at 11 sites on the face and neck using the validated Lemperle wrinkle scale. Skin rigidity was assessed at the forehead and cheek using a durometer. Participants also underwent BMD assessment by dual energy x-ray absorptiometry at the lumbar spine, left hip, and total body. The patients also underwent quantitative heel ultrasound.

Stepwise multivariable linear regression analyses explored the relationship between skin parameters and BMD. Covariates included age, body mass, race/ethnicity, age at menopause, history of smoking, multivitamins intake, and enrollment site.

The researchers found that skin wrinkle severity correlates with BMD. In particular, when wrinkles are severe, BMD is low.

"Our hypothesis, I'm very pleased to say, was substantiated by these findings," said Dr. Pal. "But we are really seeing the tip of the iceberg here. This is a tantalizing association.

"The quest for all of us really is, can we pick out markers in a cost-effective manner that may translate into overall risk detection that would prevent [fractures]?" she added.

Why look at skin wrinkles and bone density? "Well, when you look at the architecture of the skeleton and the architecture of the skin, about 90% of shared properties within tissues exist, which are the protein building blocks," Dr. Pal said.

In the skeleton, bone mineral must be deposited on some struts, and proteins provide that infrastructure, she explained. So, loss of protein in the skeleton translates into increased skeletal fragility. That structural deterioration is also seen in the skin. "As we age, the protein texture in our dermis and the deeper layers of our skin also deteriorate," Dr. Pal noted.

The women in the study are being followed longitudinally. Thus, the researchers may be able to answer questions such as whether more wrinkles are associated with a faster rate of bone loss and whether estrogen therapy has an effect on such a relationship, Dr. Pal said.

Dr. Pal and her coinvestigators reported that they have no relevant financial relationships.

BOSTON – Skin wrinkling and rigidity could give physicians a clue to bone mineral density, at least among early postmenopausal women, based on a study presented as a poster at the annual meeting of the Endocrine Society.

"In the women that we're talking about, skin wrinkling and skin rigidity – features that are easily appreciable across the table when you are looking at the patient – tie in with bone mineral density as assessed by clinical gold standards, such a as dual x-ray absorptiometry," Dr. Lubna Pal said during a press conference at the meeting.

The researchers explored possible relationships between skin wrinkling/rigidity and bone mineral density (BMD) in a cohort of early menopausal women who were enrolled in the Kronos Early Estrogen Prevention Study, a longitudinal trial of menopausal hormone therapy.

The skin ancillary study to the ongoing Kronos clinical trial included 114 women who had their last menstrual period within the past 3 years. Most of the participants were white, although 30% were not. Cross-sectional baseline data were used, said Dr. Pal, who is a reproductive endocrinologist at Yale University, New Haven, Conn.

Skin wrinkles were assessed at 11 sites on the face and neck using the validated Lemperle wrinkle scale. Skin rigidity was assessed at the forehead and cheek using a durometer. Participants also underwent BMD assessment by dual energy x-ray absorptiometry at the lumbar spine, left hip, and total body. The patients also underwent quantitative heel ultrasound.

Stepwise multivariable linear regression analyses explored the relationship between skin parameters and BMD. Covariates included age, body mass, race/ethnicity, age at menopause, history of smoking, multivitamins intake, and enrollment site.

The researchers found that skin wrinkle severity correlates with BMD. In particular, when wrinkles are severe, BMD is low.

"Our hypothesis, I'm very pleased to say, was substantiated by these findings," said Dr. Pal. "But we are really seeing the tip of the iceberg here. This is a tantalizing association.

"The quest for all of us really is, can we pick out markers in a cost-effective manner that may translate into overall risk detection that would prevent [fractures]?" she added.

Why look at skin wrinkles and bone density? "Well, when you look at the architecture of the skeleton and the architecture of the skin, about 90% of shared properties within tissues exist, which are the protein building blocks," Dr. Pal said.

In the skeleton, bone mineral must be deposited on some struts, and proteins provide that infrastructure, she explained. So, loss of protein in the skeleton translates into increased skeletal fragility. That structural deterioration is also seen in the skin. "As we age, the protein texture in our dermis and the deeper layers of our skin also deteriorate," Dr. Pal noted.

The women in the study are being followed longitudinally. Thus, the researchers may be able to answer questions such as whether more wrinkles are associated with a faster rate of bone loss and whether estrogen therapy has an effect on such a relationship, Dr. Pal said.

Dr. Pal and her coinvestigators reported that they have no relevant financial relationships.

BOSTON – Skin wrinkling and rigidity could give physicians a clue to bone mineral density, at least among early postmenopausal women, based on a study presented as a poster at the annual meeting of the Endocrine Society.

"In the women that we're talking about, skin wrinkling and skin rigidity – features that are easily appreciable across the table when you are looking at the patient – tie in with bone mineral density as assessed by clinical gold standards, such a as dual x-ray absorptiometry," Dr. Lubna Pal said during a press conference at the meeting.

The researchers explored possible relationships between skin wrinkling/rigidity and bone mineral density (BMD) in a cohort of early menopausal women who were enrolled in the Kronos Early Estrogen Prevention Study, a longitudinal trial of menopausal hormone therapy.

The skin ancillary study to the ongoing Kronos clinical trial included 114 women who had their last menstrual period within the past 3 years. Most of the participants were white, although 30% were not. Cross-sectional baseline data were used, said Dr. Pal, who is a reproductive endocrinologist at Yale University, New Haven, Conn.

Skin wrinkles were assessed at 11 sites on the face and neck using the validated Lemperle wrinkle scale. Skin rigidity was assessed at the forehead and cheek using a durometer. Participants also underwent BMD assessment by dual energy x-ray absorptiometry at the lumbar spine, left hip, and total body. The patients also underwent quantitative heel ultrasound.

Stepwise multivariable linear regression analyses explored the relationship between skin parameters and BMD. Covariates included age, body mass, race/ethnicity, age at menopause, history of smoking, multivitamins intake, and enrollment site.

The researchers found that skin wrinkle severity correlates with BMD. In particular, when wrinkles are severe, BMD is low.

"Our hypothesis, I'm very pleased to say, was substantiated by these findings," said Dr. Pal. "But we are really seeing the tip of the iceberg here. This is a tantalizing association.

"The quest for all of us really is, can we pick out markers in a cost-effective manner that may translate into overall risk detection that would prevent [fractures]?" she added.

Why look at skin wrinkles and bone density? "Well, when you look at the architecture of the skeleton and the architecture of the skin, about 90% of shared properties within tissues exist, which are the protein building blocks," Dr. Pal said.

In the skeleton, bone mineral must be deposited on some struts, and proteins provide that infrastructure, she explained. So, loss of protein in the skeleton translates into increased skeletal fragility. That structural deterioration is also seen in the skin. "As we age, the protein texture in our dermis and the deeper layers of our skin also deteriorate," Dr. Pal noted.

The women in the study are being followed longitudinally. Thus, the researchers may be able to answer questions such as whether more wrinkles are associated with a faster rate of bone loss and whether estrogen therapy has an effect on such a relationship, Dr. Pal said.

Dr. Pal and her coinvestigators reported that they have no relevant financial relationships.

SEOUL, SOUTH KOREA – New evidence indicates that an important cause of extrinsic skin aging is chronic exposure to soot and other airborne particulates generated by motor vehicle exhaust.

A strong epidemiologic association has been established between residing near a busy highway and increased skin wrinkling and pigmented spots, and a plausible biologic mechanism for causality has been established. Thus, exposure to traffic-related airborne particulate matter joins solar ultraviolet radiation and tobacco smoke as the third potentially modifiable major factor identified in extrinsic skin aging, Dr. Jean Krutmann said at the World Congress of Dermatology.

Photo credit: Sergiy Serdyuk/ISTOCKPHOTO.COM

"My first major message is that nanoparticles are present in ambient air and represent a novel threat to human skin," said Dr. Krutmann, professor of dermatology and environmental health medicine at Heinrich Heine University in Düsseldorf, Germany.

He and his coinvestigators have shown that the threat is more than skin deep.

They have previously linked chronic exposure to traffic-related fine particulate polyaromatic hydrocarbons with a diverse group of other major adverse health effects in addition to skin aging.

They have shown that at one end of the life span, such exposure impairs cognitive function in the elderly (Environ. Res. 2009;109:1,004-11); ongoing prospective studies will determine whether this exposure is also involved in the pathogenesis of Alzheimer's disease.

The same landmark German epidemiologic study that linked airborne particle exposure to mild cognitive impairment – the Study on the Influence of Air Pollution on Lung Function, Inflammation, and Aging (SALIA) – has implicated exposure to traffic-related particulate matter with increased risk of type 2 diabetes (Environ. Health Perspect. 2010;118:1,273-9).

SALIA involved close to 5,000 German women who were enrolled in the mid-1980s, when they were on average 55 years old, and who have been followed for 20 years. Participants were drawn from a heavily industrialized area of Germany as well as from low-pollution rural districts.

At the other end of the life span, Dr. Krutmann and his coinvestigators have demonstrated in prospective studies of 3,390 small-town German newborns followed to age 6 years that exposure to traffic-related airborne particulates was related in dose-response fashion to longer duration of eczema (J. Dermatol. Sci. 2009;56:99-105).

How could sooty air pollution due to incomplete combustion be involved in the pathogenesis of neurodegenerative diseases and type 2 diabetes? Animal studies demonstrate that once these fine airborne particles get into the upper respiratory tract, they can move on to the systemic circulation and exert direct inflammatory effects in other organs – including the brain and pancreas, the dermatologist explained.

The skin aging study was conducted in 400 German women aged 70-80 years who were randomly drawn from the SALIA cohort. The extent of their skin aging was assessed by means of the well-validated Score of Intrinsic and Extrinsic Skin Aging (SCINEXA). Air pollution exposure was determined by the distance between a participant’s home and the nearest major roadway with a traffic volume in excess of 10,000 vehicles per day, as well as by measurement of ambient particulate matter less than 10 mcm in diameter at fixed monitoring sites.

Air pollution exposure proved to be related in dose-response fashion to an increase in pigmented spots on the cheeks and forehead, as well as to facial wrinkles (J. Invest. Dermatol. 2010;130:2,719-26).

Dr. Krutmann said that as a nonepidemiologist, he needs to understand the potential biologic mechanism underlying an epidemiologic observation before he can accept it. He and his colleagues have recently developed such persuasive evidence through animal and in vitro human skin studies.

They have shown that the polyaromatic hydrocarbons in traffic soot activate the aryl hydrocarbon receptor (AhR) expressed on keratinocytes and melanocytes. This results in increased matrix metalloproteinase-1 activity, which in turn leads to degradation of collagen in the dermal matrix and thereby to formation of wrinkles. Activation of the AhR also stimulates melanocyte proliferation, which would explain the increased formation of pigmented spots (J. Invest. Dermatol. 2011;131:203-10).

The clinical implication of these findings is that inhibition of the AhR in skin may be a novel strategy for prevention of extrinsic skin aging. Dr. Krutmann disclosed that he is working with Symrise, a German chemical company, to develop AhR antagonists suitable for topical application in cosmetics. One such product, SymHelios 1031, is already in commercial use.

SALIA and the pediatric eczema studies were funded by the German government.

SEOUL, SOUTH KOREA – New evidence indicates that an important cause of extrinsic skin aging is chronic exposure to soot and other airborne particulates generated by motor vehicle exhaust.

A strong epidemiologic association has been established between residing near a busy highway and increased skin wrinkling and pigmented spots, and a plausible biologic mechanism for causality has been established. Thus, exposure to traffic-related airborne particulate matter joins solar ultraviolet radiation and tobacco smoke as the third potentially modifiable major factor identified in extrinsic skin aging, Dr. Jean Krutmann said at the World Congress of Dermatology.

Photo credit: Sergiy Serdyuk/ISTOCKPHOTO.COM

"My first major message is that nanoparticles are present in ambient air and represent a novel threat to human skin," said Dr. Krutmann, professor of dermatology and environmental health medicine at Heinrich Heine University in Düsseldorf, Germany.

He and his coinvestigators have shown that the threat is more than skin deep.

They have previously linked chronic exposure to traffic-related fine particulate polyaromatic hydrocarbons with a diverse group of other major adverse health effects in addition to skin aging.

They have shown that at one end of the life span, such exposure impairs cognitive function in the elderly (Environ. Res. 2009;109:1,004-11); ongoing prospective studies will determine whether this exposure is also involved in the pathogenesis of Alzheimer's disease.

The same landmark German epidemiologic study that linked airborne particle exposure to mild cognitive impairment – the Study on the Influence of Air Pollution on Lung Function, Inflammation, and Aging (SALIA) – has implicated exposure to traffic-related particulate matter with increased risk of type 2 diabetes (Environ. Health Perspect. 2010;118:1,273-9).

SALIA involved close to 5,000 German women who were enrolled in the mid-1980s, when they were on average 55 years old, and who have been followed for 20 years. Participants were drawn from a heavily industrialized area of Germany as well as from low-pollution rural districts.

At the other end of the life span, Dr. Krutmann and his coinvestigators have demonstrated in prospective studies of 3,390 small-town German newborns followed to age 6 years that exposure to traffic-related airborne particulates was related in dose-response fashion to longer duration of eczema (J. Dermatol. Sci. 2009;56:99-105).

How could sooty air pollution due to incomplete combustion be involved in the pathogenesis of neurodegenerative diseases and type 2 diabetes? Animal studies demonstrate that once these fine airborne particles get into the upper respiratory tract, they can move on to the systemic circulation and exert direct inflammatory effects in other organs – including the brain and pancreas, the dermatologist explained.

The skin aging study was conducted in 400 German women aged 70-80 years who were randomly drawn from the SALIA cohort. The extent of their skin aging was assessed by means of the well-validated Score of Intrinsic and Extrinsic Skin Aging (SCINEXA). Air pollution exposure was determined by the distance between a participant’s home and the nearest major roadway with a traffic volume in excess of 10,000 vehicles per day, as well as by measurement of ambient particulate matter less than 10 mcm in diameter at fixed monitoring sites.

Air pollution exposure proved to be related in dose-response fashion to an increase in pigmented spots on the cheeks and forehead, as well as to facial wrinkles (J. Invest. Dermatol. 2010;130:2,719-26).

Dr. Krutmann said that as a nonepidemiologist, he needs to understand the potential biologic mechanism underlying an epidemiologic observation before he can accept it. He and his colleagues have recently developed such persuasive evidence through animal and in vitro human skin studies.

They have shown that the polyaromatic hydrocarbons in traffic soot activate the aryl hydrocarbon receptor (AhR) expressed on keratinocytes and melanocytes. This results in increased matrix metalloproteinase-1 activity, which in turn leads to degradation of collagen in the dermal matrix and thereby to formation of wrinkles. Activation of the AhR also stimulates melanocyte proliferation, which would explain the increased formation of pigmented spots (J. Invest. Dermatol. 2011;131:203-10).

The clinical implication of these findings is that inhibition of the AhR in skin may be a novel strategy for prevention of extrinsic skin aging. Dr. Krutmann disclosed that he is working with Symrise, a German chemical company, to develop AhR antagonists suitable for topical application in cosmetics. One such product, SymHelios 1031, is already in commercial use.

SALIA and the pediatric eczema studies were funded by the German government.

SEOUL, SOUTH KOREA – New evidence indicates that an important cause of extrinsic skin aging is chronic exposure to soot and other airborne particulates generated by motor vehicle exhaust.

A strong epidemiologic association has been established between residing near a busy highway and increased skin wrinkling and pigmented spots, and a plausible biologic mechanism for causality has been established. Thus, exposure to traffic-related airborne particulate matter joins solar ultraviolet radiation and tobacco smoke as the third potentially modifiable major factor identified in extrinsic skin aging, Dr. Jean Krutmann said at the World Congress of Dermatology.

Photo credit: Sergiy Serdyuk/ISTOCKPHOTO.COM

"My first major message is that nanoparticles are present in ambient air and represent a novel threat to human skin," said Dr. Krutmann, professor of dermatology and environmental health medicine at Heinrich Heine University in Düsseldorf, Germany.

He and his coinvestigators have shown that the threat is more than skin deep.

They have previously linked chronic exposure to traffic-related fine particulate polyaromatic hydrocarbons with a diverse group of other major adverse health effects in addition to skin aging.

They have shown that at one end of the life span, such exposure impairs cognitive function in the elderly (Environ. Res. 2009;109:1,004-11); ongoing prospective studies will determine whether this exposure is also involved in the pathogenesis of Alzheimer's disease.

The same landmark German epidemiologic study that linked airborne particle exposure to mild cognitive impairment – the Study on the Influence of Air Pollution on Lung Function, Inflammation, and Aging (SALIA) – has implicated exposure to traffic-related particulate matter with increased risk of type 2 diabetes (Environ. Health Perspect. 2010;118:1,273-9).

SALIA involved close to 5,000 German women who were enrolled in the mid-1980s, when they were on average 55 years old, and who have been followed for 20 years. Participants were drawn from a heavily industrialized area of Germany as well as from low-pollution rural districts.

At the other end of the life span, Dr. Krutmann and his coinvestigators have demonstrated in prospective studies of 3,390 small-town German newborns followed to age 6 years that exposure to traffic-related airborne particulates was related in dose-response fashion to longer duration of eczema (J. Dermatol. Sci. 2009;56:99-105).

How could sooty air pollution due to incomplete combustion be involved in the pathogenesis of neurodegenerative diseases and type 2 diabetes? Animal studies demonstrate that once these fine airborne particles get into the upper respiratory tract, they can move on to the systemic circulation and exert direct inflammatory effects in other organs – including the brain and pancreas, the dermatologist explained.

The skin aging study was conducted in 400 German women aged 70-80 years who were randomly drawn from the SALIA cohort. The extent of their skin aging was assessed by means of the well-validated Score of Intrinsic and Extrinsic Skin Aging (SCINEXA). Air pollution exposure was determined by the distance between a participant’s home and the nearest major roadway with a traffic volume in excess of 10,000 vehicles per day, as well as by measurement of ambient particulate matter less than 10 mcm in diameter at fixed monitoring sites.

Air pollution exposure proved to be related in dose-response fashion to an increase in pigmented spots on the cheeks and forehead, as well as to facial wrinkles (J. Invest. Dermatol. 2010;130:2,719-26).

Dr. Krutmann said that as a nonepidemiologist, he needs to understand the potential biologic mechanism underlying an epidemiologic observation before he can accept it. He and his colleagues have recently developed such persuasive evidence through animal and in vitro human skin studies.

They have shown that the polyaromatic hydrocarbons in traffic soot activate the aryl hydrocarbon receptor (AhR) expressed on keratinocytes and melanocytes. This results in increased matrix metalloproteinase-1 activity, which in turn leads to degradation of collagen in the dermal matrix and thereby to formation of wrinkles. Activation of the AhR also stimulates melanocyte proliferation, which would explain the increased formation of pigmented spots (J. Invest. Dermatol. 2011;131:203-10).

The clinical implication of these findings is that inhibition of the AhR in skin may be a novel strategy for prevention of extrinsic skin aging. Dr. Krutmann disclosed that he is working with Symrise, a German chemical company, to develop AhR antagonists suitable for topical application in cosmetics. One such product, SymHelios 1031, is already in commercial use.

SALIA and the pediatric eczema studies were funded by the German government.

The Food and Drug Administration has approved LaVív, a product offering a novel approach to treating moderate to severe nasolabial folds in adults through autologous cell therapy.

The patented technology includes an advanced process that uses a patient's own fibroblasts to treat smile lines. The cells are cultured, and then injected into the patient.

The FDA approved the Fibrocell Sciences' Biologics License Application for its lead product, LaVív (azficel-T) this month (June 2011). In clinical trials, the product was well tolerated. The majority of adverse events were injection-site reactions that were generally mild to moderate in intensity and resolved within 1 week.

LaVív is expected to be available through trained clinical investigators in select metropolitan areas. As manufacturing capacity is increased and more physicians are trained, the number of cities served will expand as well, according to a company statement.

Small fibroblast samples are taken from behind the patient's ear and sent to Fibrocell's laboratory. Over a period of approximately 90 days, hundreds of millions of fibroblasts are cultured and then frozen until needed for treatment. The recommended course of LaVív administration is a series of three treatments, typically 3-6 weeks apart.

Additional information about LaVív is available at www.mylaviv.com.

The Food and Drug Administration has approved LaVív, a product offering a novel approach to treating moderate to severe nasolabial folds in adults through autologous cell therapy.

The patented technology includes an advanced process that uses a patient's own fibroblasts to treat smile lines. The cells are cultured, and then injected into the patient.

The FDA approved the Fibrocell Sciences' Biologics License Application for its lead product, LaVív (azficel-T) this month (June 2011). In clinical trials, the product was well tolerated. The majority of adverse events were injection-site reactions that were generally mild to moderate in intensity and resolved within 1 week.

LaVív is expected to be available through trained clinical investigators in select metropolitan areas. As manufacturing capacity is increased and more physicians are trained, the number of cities served will expand as well, according to a company statement.

Small fibroblast samples are taken from behind the patient's ear and sent to Fibrocell's laboratory. Over a period of approximately 90 days, hundreds of millions of fibroblasts are cultured and then frozen until needed for treatment. The recommended course of LaVív administration is a series of three treatments, typically 3-6 weeks apart.

Additional information about LaVív is available at www.mylaviv.com.

The Food and Drug Administration has approved LaVív, a product offering a novel approach to treating moderate to severe nasolabial folds in adults through autologous cell therapy.

The patented technology includes an advanced process that uses a patient's own fibroblasts to treat smile lines. The cells are cultured, and then injected into the patient.

The FDA approved the Fibrocell Sciences' Biologics License Application for its lead product, LaVív (azficel-T) this month (June 2011). In clinical trials, the product was well tolerated. The majority of adverse events were injection-site reactions that were generally mild to moderate in intensity and resolved within 1 week.

LaVív is expected to be available through trained clinical investigators in select metropolitan areas. As manufacturing capacity is increased and more physicians are trained, the number of cities served will expand as well, according to a company statement.

Small fibroblast samples are taken from behind the patient's ear and sent to Fibrocell's laboratory. Over a period of approximately 90 days, hundreds of millions of fibroblasts are cultured and then frozen until needed for treatment. The recommended course of LaVív administration is a series of three treatments, typically 3-6 weeks apart.

Additional information about LaVív is available at www.mylaviv.com.