Skin Disease Education Foundation (SDEF): Summit in Aesthetic Medicine 2011

DANA POINT, CALIF. – Despite significant advances in dermatology in recent years, little progress has been made in reducing actinic keratoses and skin cancers, Dr. Mark G. Rubin said at the SDEF Summit in Aesthetic Medicine.

"The take-home message to me in all this is, don’t get actinic keratoses," said Dr. Rubin, who practices dermatology in Beverly Hills, Calif. "We really don’t have a great therapy, so it’s important for your patients and for yourself that you limit the amount of ultraviolet light that you get, because we don’t have a wonderful treatment option for patients at this point."

That message is especially important for immunosuppressed organ transplant patients, who face an incidence of skin cancer 64-250 times higher than that of the general population.

"Immunosuppressed patients grow four times as many squamous cells than basal cells, which is the reverse of the ratio of these cancers in immunocompetent patients," he said. "Those particular tumors are much more aggressive and have a higher incidence of metastasis. Sun protection is tremendously important in these patients."

In a randomized trial of 120 transplant patients, 60 patients applied 2 mg/cm² of sunscreen with an SPF greater than 50 to the head, neck, forearms, and hands daily for 24 months, while 60 patients in the control group did not apply any sunscreen (Br. J. Derm. 2009;161 [Suppl. 3]:78-84). Both groups of patients had an equal number of AKs at the start of the trial, but at the end of 24 months, 82 new AKs developed in the control group compared with none in the sunscreen treatment group. In addition, eight patients in the control group developed squamous cell carcinoma, compared with none in the sunscreen group, while nine patients in the control group developed basal cell epithelioma, compared with two in the sunscreen group.

While fluorouracil in the form of Efudex 2% and 5%, Fluoroplex 1%, and Carac 0.5% has been a mainstay of AK treatment, imiquimod in the form of Aldara Cream 5% and Zyclara Cream 3.75% "has probably been the most popular recently," said Dr. Rubin, also of the University of California, San Diego. Another treatment option is diclofenac in the form of Solaraze 3%.

"None of these are fun therapies for patients," he said. "It’s hard to get patients to apply 5-FU more than once. They’ll do it once, hate the experience, and ask, ‘What do you have now doc, because I’m never facing that again.’ It’s made some of the other products like Solaraze, Carac, and Aldara more popular because they’re a little less brutal for the patient. But it’s important to realize that any of these products are going to impact your patients’ daily life. They’re all going to cause some redness, swelling, crusting, stinging, and burning that will go on for a period of weeks if not months, depending on the product that you use and the protocol that you follow."

A review of multiple trials suggests that these medical therapies show complete clearing of AKs in 36%-58% of patients within 1-4 months post treatment.

"It’s important to differentiate between reducing the overall bulk of precancer and eradication, or complete clearance," Dr. Rubin added. "You really want to look at complete clearance, because if you just improved it and the keratosis is smaller, 6 months later it will be back and look like you never touched it. Unless you’ve eradicated the lesion, you’re wasting your time."

Systemic retinoids such as Acitretin and Etretinate are another treatment option, yet they are not a long-term solution given their propensity to cause multiple side effects, including chapped lips, dry eyes, headaches, and hyperlipidemia.

"It’s almost unfair to put a patient on these because they’ll love it for awhile, and then you have to take it away, and then they’ll do horribly – unless you’re doing this with a second plan where you put the patient on it for 6 months to stabilize them before moving on to another treatment option, such as photodynamic therapy, which may be reasonable," Dr. Rubin said.

Chemical peels have some value for decreasing AKs in immunocompetent patients, but the results are no better than with topical medications, he said. The deeper the destruction, the better the result.

"Some actinic keratoses and squamous cell in situ go down the hair follicles," Dr. Rubin said. "If you’re not chasing it down the hair follicle you’re leaving the root behind in a lot of these patients, and that’s what creates a lot of these recurrences. Medical therapies are moderately effective if you look at them a couple of months later. But response rates are not wonderful, and the relapse rates are really terrible."

Dr. Rubin disclosed that he has received research support and consulting fees from Medicis. SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – Despite significant advances in dermatology in recent years, little progress has been made in reducing actinic keratoses and skin cancers, Dr. Mark G. Rubin said at the SDEF Summit in Aesthetic Medicine.

"The take-home message to me in all this is, don’t get actinic keratoses," said Dr. Rubin, who practices dermatology in Beverly Hills, Calif. "We really don’t have a great therapy, so it’s important for your patients and for yourself that you limit the amount of ultraviolet light that you get, because we don’t have a wonderful treatment option for patients at this point."

That message is especially important for immunosuppressed organ transplant patients, who face an incidence of skin cancer 64-250 times higher than that of the general population.

"Immunosuppressed patients grow four times as many squamous cells than basal cells, which is the reverse of the ratio of these cancers in immunocompetent patients," he said. "Those particular tumors are much more aggressive and have a higher incidence of metastasis. Sun protection is tremendously important in these patients."

In a randomized trial of 120 transplant patients, 60 patients applied 2 mg/cm² of sunscreen with an SPF greater than 50 to the head, neck, forearms, and hands daily for 24 months, while 60 patients in the control group did not apply any sunscreen (Br. J. Derm. 2009;161 [Suppl. 3]:78-84). Both groups of patients had an equal number of AKs at the start of the trial, but at the end of 24 months, 82 new AKs developed in the control group compared with none in the sunscreen treatment group. In addition, eight patients in the control group developed squamous cell carcinoma, compared with none in the sunscreen group, while nine patients in the control group developed basal cell epithelioma, compared with two in the sunscreen group.

While fluorouracil in the form of Efudex 2% and 5%, Fluoroplex 1%, and Carac 0.5% has been a mainstay of AK treatment, imiquimod in the form of Aldara Cream 5% and Zyclara Cream 3.75% "has probably been the most popular recently," said Dr. Rubin, also of the University of California, San Diego. Another treatment option is diclofenac in the form of Solaraze 3%.

"None of these are fun therapies for patients," he said. "It’s hard to get patients to apply 5-FU more than once. They’ll do it once, hate the experience, and ask, ‘What do you have now doc, because I’m never facing that again.’ It’s made some of the other products like Solaraze, Carac, and Aldara more popular because they’re a little less brutal for the patient. But it’s important to realize that any of these products are going to impact your patients’ daily life. They’re all going to cause some redness, swelling, crusting, stinging, and burning that will go on for a period of weeks if not months, depending on the product that you use and the protocol that you follow."

A review of multiple trials suggests that these medical therapies show complete clearing of AKs in 36%-58% of patients within 1-4 months post treatment.

"It’s important to differentiate between reducing the overall bulk of precancer and eradication, or complete clearance," Dr. Rubin added. "You really want to look at complete clearance, because if you just improved it and the keratosis is smaller, 6 months later it will be back and look like you never touched it. Unless you’ve eradicated the lesion, you’re wasting your time."

Systemic retinoids such as Acitretin and Etretinate are another treatment option, yet they are not a long-term solution given their propensity to cause multiple side effects, including chapped lips, dry eyes, headaches, and hyperlipidemia.

"It’s almost unfair to put a patient on these because they’ll love it for awhile, and then you have to take it away, and then they’ll do horribly – unless you’re doing this with a second plan where you put the patient on it for 6 months to stabilize them before moving on to another treatment option, such as photodynamic therapy, which may be reasonable," Dr. Rubin said.

Chemical peels have some value for decreasing AKs in immunocompetent patients, but the results are no better than with topical medications, he said. The deeper the destruction, the better the result.

"Some actinic keratoses and squamous cell in situ go down the hair follicles," Dr. Rubin said. "If you’re not chasing it down the hair follicle you’re leaving the root behind in a lot of these patients, and that’s what creates a lot of these recurrences. Medical therapies are moderately effective if you look at them a couple of months later. But response rates are not wonderful, and the relapse rates are really terrible."

Dr. Rubin disclosed that he has received research support and consulting fees from Medicis. SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – Despite significant advances in dermatology in recent years, little progress has been made in reducing actinic keratoses and skin cancers, Dr. Mark G. Rubin said at the SDEF Summit in Aesthetic Medicine.

"The take-home message to me in all this is, don’t get actinic keratoses," said Dr. Rubin, who practices dermatology in Beverly Hills, Calif. "We really don’t have a great therapy, so it’s important for your patients and for yourself that you limit the amount of ultraviolet light that you get, because we don’t have a wonderful treatment option for patients at this point."

That message is especially important for immunosuppressed organ transplant patients, who face an incidence of skin cancer 64-250 times higher than that of the general population.

"Immunosuppressed patients grow four times as many squamous cells than basal cells, which is the reverse of the ratio of these cancers in immunocompetent patients," he said. "Those particular tumors are much more aggressive and have a higher incidence of metastasis. Sun protection is tremendously important in these patients."

In a randomized trial of 120 transplant patients, 60 patients applied 2 mg/cm² of sunscreen with an SPF greater than 50 to the head, neck, forearms, and hands daily for 24 months, while 60 patients in the control group did not apply any sunscreen (Br. J. Derm. 2009;161 [Suppl. 3]:78-84). Both groups of patients had an equal number of AKs at the start of the trial, but at the end of 24 months, 82 new AKs developed in the control group compared with none in the sunscreen treatment group. In addition, eight patients in the control group developed squamous cell carcinoma, compared with none in the sunscreen group, while nine patients in the control group developed basal cell epithelioma, compared with two in the sunscreen group.

While fluorouracil in the form of Efudex 2% and 5%, Fluoroplex 1%, and Carac 0.5% has been a mainstay of AK treatment, imiquimod in the form of Aldara Cream 5% and Zyclara Cream 3.75% "has probably been the most popular recently," said Dr. Rubin, also of the University of California, San Diego. Another treatment option is diclofenac in the form of Solaraze 3%.

"None of these are fun therapies for patients," he said. "It’s hard to get patients to apply 5-FU more than once. They’ll do it once, hate the experience, and ask, ‘What do you have now doc, because I’m never facing that again.’ It’s made some of the other products like Solaraze, Carac, and Aldara more popular because they’re a little less brutal for the patient. But it’s important to realize that any of these products are going to impact your patients’ daily life. They’re all going to cause some redness, swelling, crusting, stinging, and burning that will go on for a period of weeks if not months, depending on the product that you use and the protocol that you follow."

A review of multiple trials suggests that these medical therapies show complete clearing of AKs in 36%-58% of patients within 1-4 months post treatment.

"It’s important to differentiate between reducing the overall bulk of precancer and eradication, or complete clearance," Dr. Rubin added. "You really want to look at complete clearance, because if you just improved it and the keratosis is smaller, 6 months later it will be back and look like you never touched it. Unless you’ve eradicated the lesion, you’re wasting your time."

Systemic retinoids such as Acitretin and Etretinate are another treatment option, yet they are not a long-term solution given their propensity to cause multiple side effects, including chapped lips, dry eyes, headaches, and hyperlipidemia.

"It’s almost unfair to put a patient on these because they’ll love it for awhile, and then you have to take it away, and then they’ll do horribly – unless you’re doing this with a second plan where you put the patient on it for 6 months to stabilize them before moving on to another treatment option, such as photodynamic therapy, which may be reasonable," Dr. Rubin said.

Chemical peels have some value for decreasing AKs in immunocompetent patients, but the results are no better than with topical medications, he said. The deeper the destruction, the better the result.

"Some actinic keratoses and squamous cell in situ go down the hair follicles," Dr. Rubin said. "If you’re not chasing it down the hair follicle you’re leaving the root behind in a lot of these patients, and that’s what creates a lot of these recurrences. Medical therapies are moderately effective if you look at them a couple of months later. But response rates are not wonderful, and the relapse rates are really terrible."

Dr. Rubin disclosed that he has received research support and consulting fees from Medicis. SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – Scar formation and fibrosis can be reduced by altering the mechanical environment of wounds, results from a phase I study found.

At the Summit in Aesthetic Medicine, sponsored by Skin Disease Education Foundation (SDEF), Dr. Geoffrey C. Gurtner presented findings from a study in which nine patients undergoing elective abdominal surgery were treated postoperatively with a stress-shielding polymer on one side while the other side was treated with standard wound care.

©Neodyne Biosciences, Inc

The device, manufactured by Neodyne Biosciences, looks like a Band-Aid strip and is stretched over the incision after sutures are removed. It conforms to the wound and adheres to skin, creating "a compressive region that has no level of mechanical stimulation or distractive strain," said Dr. Gurtner, professor of surgery at Stanford (Calif.) University. "Essentially, you create stress risers in the unwounded skin and a mechanically privileged environment in the wounded skin."

A panel of three independent plastic surgeons reviewed 18 photos of the scars (nine treated, nine control) taken 6-12 months after surgery (Ann. Surg. 2011 May 19 [doi: 10.1097/SLA.0b013e318220b159]). They used a visual analog scale (VAS) that ranged from 0 (very good scar) to 100 (very poor hypertrophic scar).

Dr. Gurtner reported that the average VAS score in the treated group was 18.6, while the average VAS score in the control group was 50.5, a difference that was statistically significant (P = .0039). "In none of the cases was the treated scar worse than the control scar, which I think is different than some of the biologic agents we’ve seen over the last few years," he said.*

A panel of lay persons who reviewed the photos reported similar results that favored the treated group (P = .004).

In earlier mouse studies of wound environment manipulation, Dr. Gurtner and his associates found that focal adhesion kinase (FAK) is a critical regulator in the formation of hypertrophic scars. He described FAK as "a molecule that exists on the inner surface of cell membranes and transmits forces that are set in the external extracellular matrix to the inside of the cell. FAK transmits those forces into biological or biochemical cues that then turn on genes in the nucleus and make the cells do different things. This seems to be a very important molecule in the ability of us to produce hypertrophic scars in mice. If you take out FAK, you can prevent hypertrophic scar formation."

FAK is a target that has been examined extensively in cancer, Dr. Gurtner said, suggesting that in the next few years, "We should have products that will not only be able to treat incision wounds but will also be able to treat large burn injuries. You need to fool the cells into thinking they’re in a different mechanical environment, either by using small molecule or pharmacologic blocking therapies such as fat inhibitors, or by using biomaterials that provide cues in a controlled way that minimize the amount of mechanical stimulation that the fibroblasts feel in the healing wound so as to mitigate the inflammation and subsequent fibrosis."

The study was supported by a Wallace H. Coulter Translational Partners Grant; the Armed Forces Institute of Regenerative Medicine; the Hagey Family Endowed Fund in Stem Cell Research and Regenerative Medicine; and the Oak Foundation. Neodyne Biosciences supplied the surgical dressings used in the study. Dr. Gurtner disclosed that he holds an equity interest in Neodyne.

SDEF and this news organization are owned by Elsevier.

*Correction 8/22/11: An earlier version of this story misstated the VAS scores for the two groups of patients.

DANA POINT, CALIF. – Scar formation and fibrosis can be reduced by altering the mechanical environment of wounds, results from a phase I study found.

At the Summit in Aesthetic Medicine, sponsored by Skin Disease Education Foundation (SDEF), Dr. Geoffrey C. Gurtner presented findings from a study in which nine patients undergoing elective abdominal surgery were treated postoperatively with a stress-shielding polymer on one side while the other side was treated with standard wound care.

©Neodyne Biosciences, Inc

The device, manufactured by Neodyne Biosciences, looks like a Band-Aid strip and is stretched over the incision after sutures are removed. It conforms to the wound and adheres to skin, creating "a compressive region that has no level of mechanical stimulation or distractive strain," said Dr. Gurtner, professor of surgery at Stanford (Calif.) University. "Essentially, you create stress risers in the unwounded skin and a mechanically privileged environment in the wounded skin."

A panel of three independent plastic surgeons reviewed 18 photos of the scars (nine treated, nine control) taken 6-12 months after surgery (Ann. Surg. 2011 May 19 [doi: 10.1097/SLA.0b013e318220b159]). They used a visual analog scale (VAS) that ranged from 0 (very good scar) to 100 (very poor hypertrophic scar).

Dr. Gurtner reported that the average VAS score in the treated group was 18.6, while the average VAS score in the control group was 50.5, a difference that was statistically significant (P = .0039). "In none of the cases was the treated scar worse than the control scar, which I think is different than some of the biologic agents we’ve seen over the last few years," he said.*

A panel of lay persons who reviewed the photos reported similar results that favored the treated group (P = .004).

In earlier mouse studies of wound environment manipulation, Dr. Gurtner and his associates found that focal adhesion kinase (FAK) is a critical regulator in the formation of hypertrophic scars. He described FAK as "a molecule that exists on the inner surface of cell membranes and transmits forces that are set in the external extracellular matrix to the inside of the cell. FAK transmits those forces into biological or biochemical cues that then turn on genes in the nucleus and make the cells do different things. This seems to be a very important molecule in the ability of us to produce hypertrophic scars in mice. If you take out FAK, you can prevent hypertrophic scar formation."

FAK is a target that has been examined extensively in cancer, Dr. Gurtner said, suggesting that in the next few years, "We should have products that will not only be able to treat incision wounds but will also be able to treat large burn injuries. You need to fool the cells into thinking they’re in a different mechanical environment, either by using small molecule or pharmacologic blocking therapies such as fat inhibitors, or by using biomaterials that provide cues in a controlled way that minimize the amount of mechanical stimulation that the fibroblasts feel in the healing wound so as to mitigate the inflammation and subsequent fibrosis."

The study was supported by a Wallace H. Coulter Translational Partners Grant; the Armed Forces Institute of Regenerative Medicine; the Hagey Family Endowed Fund in Stem Cell Research and Regenerative Medicine; and the Oak Foundation. Neodyne Biosciences supplied the surgical dressings used in the study. Dr. Gurtner disclosed that he holds an equity interest in Neodyne.

SDEF and this news organization are owned by Elsevier.

*Correction 8/22/11: An earlier version of this story misstated the VAS scores for the two groups of patients.

DANA POINT, CALIF. – Scar formation and fibrosis can be reduced by altering the mechanical environment of wounds, results from a phase I study found.

At the Summit in Aesthetic Medicine, sponsored by Skin Disease Education Foundation (SDEF), Dr. Geoffrey C. Gurtner presented findings from a study in which nine patients undergoing elective abdominal surgery were treated postoperatively with a stress-shielding polymer on one side while the other side was treated with standard wound care.

©Neodyne Biosciences, Inc

The device, manufactured by Neodyne Biosciences, looks like a Band-Aid strip and is stretched over the incision after sutures are removed. It conforms to the wound and adheres to skin, creating "a compressive region that has no level of mechanical stimulation or distractive strain," said Dr. Gurtner, professor of surgery at Stanford (Calif.) University. "Essentially, you create stress risers in the unwounded skin and a mechanically privileged environment in the wounded skin."

A panel of three independent plastic surgeons reviewed 18 photos of the scars (nine treated, nine control) taken 6-12 months after surgery (Ann. Surg. 2011 May 19 [doi: 10.1097/SLA.0b013e318220b159]). They used a visual analog scale (VAS) that ranged from 0 (very good scar) to 100 (very poor hypertrophic scar).

Dr. Gurtner reported that the average VAS score in the treated group was 18.6, while the average VAS score in the control group was 50.5, a difference that was statistically significant (P = .0039). "In none of the cases was the treated scar worse than the control scar, which I think is different than some of the biologic agents we’ve seen over the last few years," he said.*

A panel of lay persons who reviewed the photos reported similar results that favored the treated group (P = .004).

In earlier mouse studies of wound environment manipulation, Dr. Gurtner and his associates found that focal adhesion kinase (FAK) is a critical regulator in the formation of hypertrophic scars. He described FAK as "a molecule that exists on the inner surface of cell membranes and transmits forces that are set in the external extracellular matrix to the inside of the cell. FAK transmits those forces into biological or biochemical cues that then turn on genes in the nucleus and make the cells do different things. This seems to be a very important molecule in the ability of us to produce hypertrophic scars in mice. If you take out FAK, you can prevent hypertrophic scar formation."

FAK is a target that has been examined extensively in cancer, Dr. Gurtner said, suggesting that in the next few years, "We should have products that will not only be able to treat incision wounds but will also be able to treat large burn injuries. You need to fool the cells into thinking they’re in a different mechanical environment, either by using small molecule or pharmacologic blocking therapies such as fat inhibitors, or by using biomaterials that provide cues in a controlled way that minimize the amount of mechanical stimulation that the fibroblasts feel in the healing wound so as to mitigate the inflammation and subsequent fibrosis."

The study was supported by a Wallace H. Coulter Translational Partners Grant; the Armed Forces Institute of Regenerative Medicine; the Hagey Family Endowed Fund in Stem Cell Research and Regenerative Medicine; and the Oak Foundation. Neodyne Biosciences supplied the surgical dressings used in the study. Dr. Gurtner disclosed that he holds an equity interest in Neodyne.

SDEF and this news organization are owned by Elsevier.

*Correction 8/22/11: An earlier version of this story misstated the VAS scores for the two groups of patients.

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.

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.

DANA POINT, CALIF. – In the clinical experience of Dr. George J. Hruza, bipolar fractionated radiofrequency provides good wrinkle effacement, especially in the periorbital area.

"The benefits of bipolar fractionated radiofrequency include a limited downtime, no adverse events are seen, and any skin type can be treated," Dr. Hruza said at the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF).

Dr. Hruza, clinical professor of dermatology at St. Louis University, presented findings from a study of 22 adults with Fitzpatrick skin types I-IV who were treated with bipolar fractionated radiofrequency for visible wrinkles and/or elastosis. He and his associates used the Food and Drug Administration–cleared eMatrix radiofrequency device (Syneron) to treat two of the following facial regions per patient: the periorbital region, the perioral region, the cheeks, and the forehead.

Photo courtesy Dr. George J. Hruza

Both 64 and 144 pin tips were used; energy was delivered at a range of 2-14 joules per pulse, or 20 J/double pulse, for a maximum duration of 50 milliseconds per pulse. Each patient underwent three treatments at 3 weeks apart. Topical anesthesia was used, and the patients were followed up a month after the last treatment.

Photographic analysis at the 1-month follow-up revealed that fine lines, smoothness, tightness, and brightness improved in about half of the patients by at least 40%. Periorbital photographic results demonstrated a mean improvement in fine lines of at least 30%, with almost all patients showing clinically significant improvement. A 6-month follow-up study of the patients showed persistence of the improvement.

Dr. Hruza noted that patients may experience micro peeling for 2-4 days after undergoing bipolar fractionated radiofrequency.

Photo courtesy Dr. George J. Hruza

An emerging technology for deeper skin lesions is dermal bipolar fractionated radiofrequency, which delivers radiofrequency energy within the dermis via micro-needle electrode pairs. "Ninety-six percent of energy is absorbed in the dermis, and the thermal profile is confined along and between the needles," Dr. Hruza said. "This creates a controlled lesion and a fractionated zone of thermal injury."

Tumescent anesthesia is recommended for bipolar dermal fractionated radiofrequency, he said, because it protects deeper skin structures and reduces bleeding. The procedure typically requires 100-300 insertions in the lower face and upper neck. The needle entry points typically close in 2 hours.

Dr. Hruza said that he had no relevant disclosures.

SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – In the clinical experience of Dr. George J. Hruza, bipolar fractionated radiofrequency provides good wrinkle effacement, especially in the periorbital area.

"The benefits of bipolar fractionated radiofrequency include a limited downtime, no adverse events are seen, and any skin type can be treated," Dr. Hruza said at the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF).

Dr. Hruza, clinical professor of dermatology at St. Louis University, presented findings from a study of 22 adults with Fitzpatrick skin types I-IV who were treated with bipolar fractionated radiofrequency for visible wrinkles and/or elastosis. He and his associates used the Food and Drug Administration–cleared eMatrix radiofrequency device (Syneron) to treat two of the following facial regions per patient: the periorbital region, the perioral region, the cheeks, and the forehead.

Photo courtesy Dr. George J. Hruza

Both 64 and 144 pin tips were used; energy was delivered at a range of 2-14 joules per pulse, or 20 J/double pulse, for a maximum duration of 50 milliseconds per pulse. Each patient underwent three treatments at 3 weeks apart. Topical anesthesia was used, and the patients were followed up a month after the last treatment.

Photographic analysis at the 1-month follow-up revealed that fine lines, smoothness, tightness, and brightness improved in about half of the patients by at least 40%. Periorbital photographic results demonstrated a mean improvement in fine lines of at least 30%, with almost all patients showing clinically significant improvement. A 6-month follow-up study of the patients showed persistence of the improvement.

Dr. Hruza noted that patients may experience micro peeling for 2-4 days after undergoing bipolar fractionated radiofrequency.

Photo courtesy Dr. George J. Hruza

An emerging technology for deeper skin lesions is dermal bipolar fractionated radiofrequency, which delivers radiofrequency energy within the dermis via micro-needle electrode pairs. "Ninety-six percent of energy is absorbed in the dermis, and the thermal profile is confined along and between the needles," Dr. Hruza said. "This creates a controlled lesion and a fractionated zone of thermal injury."

Tumescent anesthesia is recommended for bipolar dermal fractionated radiofrequency, he said, because it protects deeper skin structures and reduces bleeding. The procedure typically requires 100-300 insertions in the lower face and upper neck. The needle entry points typically close in 2 hours.

Dr. Hruza said that he had no relevant disclosures.

SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – In the clinical experience of Dr. George J. Hruza, bipolar fractionated radiofrequency provides good wrinkle effacement, especially in the periorbital area.

"The benefits of bipolar fractionated radiofrequency include a limited downtime, no adverse events are seen, and any skin type can be treated," Dr. Hruza said at the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF).

Dr. Hruza, clinical professor of dermatology at St. Louis University, presented findings from a study of 22 adults with Fitzpatrick skin types I-IV who were treated with bipolar fractionated radiofrequency for visible wrinkles and/or elastosis. He and his associates used the Food and Drug Administration–cleared eMatrix radiofrequency device (Syneron) to treat two of the following facial regions per patient: the periorbital region, the perioral region, the cheeks, and the forehead.

Photo courtesy Dr. George J. Hruza

Both 64 and 144 pin tips were used; energy was delivered at a range of 2-14 joules per pulse, or 20 J/double pulse, for a maximum duration of 50 milliseconds per pulse. Each patient underwent three treatments at 3 weeks apart. Topical anesthesia was used, and the patients were followed up a month after the last treatment.

Photographic analysis at the 1-month follow-up revealed that fine lines, smoothness, tightness, and brightness improved in about half of the patients by at least 40%. Periorbital photographic results demonstrated a mean improvement in fine lines of at least 30%, with almost all patients showing clinically significant improvement. A 6-month follow-up study of the patients showed persistence of the improvement.

Dr. Hruza noted that patients may experience micro peeling for 2-4 days after undergoing bipolar fractionated radiofrequency.

Photo courtesy Dr. George J. Hruza

An emerging technology for deeper skin lesions is dermal bipolar fractionated radiofrequency, which delivers radiofrequency energy within the dermis via micro-needle electrode pairs. "Ninety-six percent of energy is absorbed in the dermis, and the thermal profile is confined along and between the needles," Dr. Hruza said. "This creates a controlled lesion and a fractionated zone of thermal injury."

Tumescent anesthesia is recommended for bipolar dermal fractionated radiofrequency, he said, because it protects deeper skin structures and reduces bleeding. The procedure typically requires 100-300 insertions in the lower face and upper neck. The needle entry points typically close in 2 hours.

Dr. Hruza said that he had no relevant disclosures.

SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – Practice skepticism when it comes to the efficacy of noninvasive fat removal devices, advised Dr. Matthew A. Avram.

"Fat removal has a long history of 'snake oil' salesmanship," Dr. Avram said at the Summit in Aesthetic Medicine, which was sponsored by Skin Disease Education Foundation (SDEF). "You can count on this to continue, because many of these devices do little, if anything. It is important to critically assess these technologies in this emerging field."

Focused Ultrasound

Dr. Avram, faculty director for procedural dermatology training at Harvard Medical School and director of the dermatology laser and cosmetic center at Massachusetts General Hospital, both in Boston, discussed the evidence surrounding devices for noninvasive fat reduction.

One non–Food and Drug Administration–cleared modality being studied is focused ultrasound, which delivers mechanical, nonthermal energy to the thigh, abdomen, and flanks. A study of 30 patients who were treated once a month for 3 months demonstrated a circumference reduction of 2-4 cm in the treated sites (Lasers Surg. Med. 2007;39:315-23). Liver function tests, a lipid panel, and liver ultrasound showed no adverse systemic effects from the procedure.

However, Dr. Avram noted that the study is limited because there was no untreated control group and that circumference "is an inherently imprecise measure of improvement that can be manipulated." MRI would prove objective improvement, he said, but it was not performed in this trial.

In a subsequent study from Hong Kong, 53 patients underwent treatment once a month for 3 months for body contouring (Lasers Surg. Med. 2009; 41:751-9). No significant changes were observed in circumference and caliper measurements, and patients rated their satisfaction as poor.

High-Intensity Focused Ultrasound

High-intensity focused ultrasound, which is also not FDA cleared, involves the rapid heating of adipocytes that are purported to produce coagulative necrosis and cell death in adipose tissue. A retrospective chart review of the modality that was used in 85 patients who underwent one treatment session showed a mean 4.6 cm decrease in waist circumference after 3 months (Aesth. Plast. Surg. 2010;34:577-82). Adverse events that lasted 4-12 weeks occurred in 12% of subjects and included prolonged tenderness, ecchymosis, nodules, and edema, as well as procedural pain in one patient, which required discontinuation of the procedure.

Dr. Avram called high-intensity focused ultrasound a promising technology, "but it's difficult to assess its efficacy. Further study of this technology is needed."

Monopolar Radiofrequency

Monopolar radiofrequency, conventionally used for tissue tightening of the face, has produced lipoatrophy with aggressive settings as a complication. "Perhaps this can be harnessed to effectively treat fat," he said, noting that clinical studies are currently underway.

Low-Level Light Therapy

Low-level light therapy, an FDA-cleared modality for fat removal, uses a multiple head, low-level diode laser at an energy level of 635 nm, which is "roughly equivalent to a laser pointer," Dr. Avram said. In one randomized trial, 59 patients received three treatments of the technology or sham treatment per week for 2 weeks (Lasers Surg. Med. 2009;41:799-809). At 2 weeks, mean circumference reductions in the treatment group were 0.98 inches at the waist, 1.05 inches at the hip, and 0.85 inches at the right thigh and 0.65 inches at the left thigh. Circumference increased in the 2 weeks following treatment.

Dr. Avram said the study was poorly designed because there was no untreated control group, the duration of treatment was only 2 weeks, and there was no ultrasound or other noninvasive evidence of decreased fat layer. "Treat with extreme skepticism," he advised.

Cryolipolysis

Perhaps the most promising technology is cryolipolysis, he said, which is FDA cleared for noninvasive fat removal. Cryolipolysis involves the noninvasive cooling of fat to selectively cause cell death without damage to surrounding tissue.

The mechanism of action of cryolipolysis is believed to involve selective crystallization of lipids in fat cells at temperatures near freezing. "Apoptotic fat cell death is followed by slow dissolution of the fat cell and a gradual release of lipids," Dr. Avram explained. "The inflammatory process results in fat layer reduction over 2-4 months."

When human studies of the technology were first conducted in 2008, enrollment was restricted to 32 patients whose "love handles" were treated at a cooling intensity factor (CIF) of 33 for 60 minutes, and progressed to higher rates of energy extractions for 45 minutes per application site. One side was treated; the untreated contralateral side served as the control.

Efficacy was evaluated at 4 months post treatment via visual assessment as a primary end point, as well as ultrasound and histology. The ultrasound results demonstrated an average 23% decrease in fat layer thickness.

"In this initial group of 32 love handle patients treated once, discernible changes were seen on the treated side vs. baseline of the treated side, and compared to the untreated contralateral control," Dr. Avram said of the findings presented during a poster session at the 2008 annual meeting of the American Society for Dermatologic Surgery. "This unique study design [using each patient as his or her own control], provided very powerful evidence that this was a true treatment effect rather than a change in the patient's diet or exercise pattern during the 4 months after this single procedure exposure."

Common effects after cryolipolysis include redness, which lasts minutes to a few hours; bruising, which may last for a few weeks; and temporary dulling of sensation in the treated area, which typically resolves in 1-8 weeks. No postprocedural changes in pigmentation or laboratory abnormalities have been observed, he said.

About 1 in 2,000 patients experiences severe pain beginning 3-7 days post treatment, which translates into 26 reported cases out of 60,000 treatments. "We are not sure why these occur, but these cases completely resolve with no sequelae," Dr. Avram said.

He emphasized that cryolipolysis is not a replacement for liposuction. "It is not a weight-loss device," he said. "It's best suited for local fat removal resistant to exercise in relatively fit patients."

Dr. Avram disclosed holding stock options in Zeltiq Aesthetics, which manufactures cryolipolysis equipment. SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – Practice skepticism when it comes to the efficacy of noninvasive fat removal devices, advised Dr. Matthew A. Avram.

"Fat removal has a long history of 'snake oil' salesmanship," Dr. Avram said at the Summit in Aesthetic Medicine, which was sponsored by Skin Disease Education Foundation (SDEF). "You can count on this to continue, because many of these devices do little, if anything. It is important to critically assess these technologies in this emerging field."

Focused Ultrasound

Dr. Avram, faculty director for procedural dermatology training at Harvard Medical School and director of the dermatology laser and cosmetic center at Massachusetts General Hospital, both in Boston, discussed the evidence surrounding devices for noninvasive fat reduction.

One non–Food and Drug Administration–cleared modality being studied is focused ultrasound, which delivers mechanical, nonthermal energy to the thigh, abdomen, and flanks. A study of 30 patients who were treated once a month for 3 months demonstrated a circumference reduction of 2-4 cm in the treated sites (Lasers Surg. Med. 2007;39:315-23). Liver function tests, a lipid panel, and liver ultrasound showed no adverse systemic effects from the procedure.

However, Dr. Avram noted that the study is limited because there was no untreated control group and that circumference "is an inherently imprecise measure of improvement that can be manipulated." MRI would prove objective improvement, he said, but it was not performed in this trial.

In a subsequent study from Hong Kong, 53 patients underwent treatment once a month for 3 months for body contouring (Lasers Surg. Med. 2009; 41:751-9). No significant changes were observed in circumference and caliper measurements, and patients rated their satisfaction as poor.

High-Intensity Focused Ultrasound

High-intensity focused ultrasound, which is also not FDA cleared, involves the rapid heating of adipocytes that are purported to produce coagulative necrosis and cell death in adipose tissue. A retrospective chart review of the modality that was used in 85 patients who underwent one treatment session showed a mean 4.6 cm decrease in waist circumference after 3 months (Aesth. Plast. Surg. 2010;34:577-82). Adverse events that lasted 4-12 weeks occurred in 12% of subjects and included prolonged tenderness, ecchymosis, nodules, and edema, as well as procedural pain in one patient, which required discontinuation of the procedure.

Dr. Avram called high-intensity focused ultrasound a promising technology, "but it's difficult to assess its efficacy. Further study of this technology is needed."

Monopolar Radiofrequency

Monopolar radiofrequency, conventionally used for tissue tightening of the face, has produced lipoatrophy with aggressive settings as a complication. "Perhaps this can be harnessed to effectively treat fat," he said, noting that clinical studies are currently underway.

Low-Level Light Therapy

Low-level light therapy, an FDA-cleared modality for fat removal, uses a multiple head, low-level diode laser at an energy level of 635 nm, which is "roughly equivalent to a laser pointer," Dr. Avram said. In one randomized trial, 59 patients received three treatments of the technology or sham treatment per week for 2 weeks (Lasers Surg. Med. 2009;41:799-809). At 2 weeks, mean circumference reductions in the treatment group were 0.98 inches at the waist, 1.05 inches at the hip, and 0.85 inches at the right thigh and 0.65 inches at the left thigh. Circumference increased in the 2 weeks following treatment.

Dr. Avram said the study was poorly designed because there was no untreated control group, the duration of treatment was only 2 weeks, and there was no ultrasound or other noninvasive evidence of decreased fat layer. "Treat with extreme skepticism," he advised.

Cryolipolysis

Perhaps the most promising technology is cryolipolysis, he said, which is FDA cleared for noninvasive fat removal. Cryolipolysis involves the noninvasive cooling of fat to selectively cause cell death without damage to surrounding tissue.

The mechanism of action of cryolipolysis is believed to involve selective crystallization of lipids in fat cells at temperatures near freezing. "Apoptotic fat cell death is followed by slow dissolution of the fat cell and a gradual release of lipids," Dr. Avram explained. "The inflammatory process results in fat layer reduction over 2-4 months."

When human studies of the technology were first conducted in 2008, enrollment was restricted to 32 patients whose "love handles" were treated at a cooling intensity factor (CIF) of 33 for 60 minutes, and progressed to higher rates of energy extractions for 45 minutes per application site. One side was treated; the untreated contralateral side served as the control.

Efficacy was evaluated at 4 months post treatment via visual assessment as a primary end point, as well as ultrasound and histology. The ultrasound results demonstrated an average 23% decrease in fat layer thickness.

"In this initial group of 32 love handle patients treated once, discernible changes were seen on the treated side vs. baseline of the treated side, and compared to the untreated contralateral control," Dr. Avram said of the findings presented during a poster session at the 2008 annual meeting of the American Society for Dermatologic Surgery. "This unique study design [using each patient as his or her own control], provided very powerful evidence that this was a true treatment effect rather than a change in the patient's diet or exercise pattern during the 4 months after this single procedure exposure."

Common effects after cryolipolysis include redness, which lasts minutes to a few hours; bruising, which may last for a few weeks; and temporary dulling of sensation in the treated area, which typically resolves in 1-8 weeks. No postprocedural changes in pigmentation or laboratory abnormalities have been observed, he said.

About 1 in 2,000 patients experiences severe pain beginning 3-7 days post treatment, which translates into 26 reported cases out of 60,000 treatments. "We are not sure why these occur, but these cases completely resolve with no sequelae," Dr. Avram said.

He emphasized that cryolipolysis is not a replacement for liposuction. "It is not a weight-loss device," he said. "It's best suited for local fat removal resistant to exercise in relatively fit patients."

Dr. Avram disclosed holding stock options in Zeltiq Aesthetics, which manufactures cryolipolysis equipment. SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – Practice skepticism when it comes to the efficacy of noninvasive fat removal devices, advised Dr. Matthew A. Avram.

"Fat removal has a long history of 'snake oil' salesmanship," Dr. Avram said at the Summit in Aesthetic Medicine, which was sponsored by Skin Disease Education Foundation (SDEF). "You can count on this to continue, because many of these devices do little, if anything. It is important to critically assess these technologies in this emerging field."

Focused Ultrasound

Dr. Avram, faculty director for procedural dermatology training at Harvard Medical School and director of the dermatology laser and cosmetic center at Massachusetts General Hospital, both in Boston, discussed the evidence surrounding devices for noninvasive fat reduction.

One non–Food and Drug Administration–cleared modality being studied is focused ultrasound, which delivers mechanical, nonthermal energy to the thigh, abdomen, and flanks. A study of 30 patients who were treated once a month for 3 months demonstrated a circumference reduction of 2-4 cm in the treated sites (Lasers Surg. Med. 2007;39:315-23). Liver function tests, a lipid panel, and liver ultrasound showed no adverse systemic effects from the procedure.

However, Dr. Avram noted that the study is limited because there was no untreated control group and that circumference "is an inherently imprecise measure of improvement that can be manipulated." MRI would prove objective improvement, he said, but it was not performed in this trial.

In a subsequent study from Hong Kong, 53 patients underwent treatment once a month for 3 months for body contouring (Lasers Surg. Med. 2009; 41:751-9). No significant changes were observed in circumference and caliper measurements, and patients rated their satisfaction as poor.

High-Intensity Focused Ultrasound

High-intensity focused ultrasound, which is also not FDA cleared, involves the rapid heating of adipocytes that are purported to produce coagulative necrosis and cell death in adipose tissue. A retrospective chart review of the modality that was used in 85 patients who underwent one treatment session showed a mean 4.6 cm decrease in waist circumference after 3 months (Aesth. Plast. Surg. 2010;34:577-82). Adverse events that lasted 4-12 weeks occurred in 12% of subjects and included prolonged tenderness, ecchymosis, nodules, and edema, as well as procedural pain in one patient, which required discontinuation of the procedure.

Dr. Avram called high-intensity focused ultrasound a promising technology, "but it's difficult to assess its efficacy. Further study of this technology is needed."

Monopolar Radiofrequency

Monopolar radiofrequency, conventionally used for tissue tightening of the face, has produced lipoatrophy with aggressive settings as a complication. "Perhaps this can be harnessed to effectively treat fat," he said, noting that clinical studies are currently underway.

Low-Level Light Therapy

Low-level light therapy, an FDA-cleared modality for fat removal, uses a multiple head, low-level diode laser at an energy level of 635 nm, which is "roughly equivalent to a laser pointer," Dr. Avram said. In one randomized trial, 59 patients received three treatments of the technology or sham treatment per week for 2 weeks (Lasers Surg. Med. 2009;41:799-809). At 2 weeks, mean circumference reductions in the treatment group were 0.98 inches at the waist, 1.05 inches at the hip, and 0.85 inches at the right thigh and 0.65 inches at the left thigh. Circumference increased in the 2 weeks following treatment.

Dr. Avram said the study was poorly designed because there was no untreated control group, the duration of treatment was only 2 weeks, and there was no ultrasound or other noninvasive evidence of decreased fat layer. "Treat with extreme skepticism," he advised.

Cryolipolysis

Perhaps the most promising technology is cryolipolysis, he said, which is FDA cleared for noninvasive fat removal. Cryolipolysis involves the noninvasive cooling of fat to selectively cause cell death without damage to surrounding tissue.

The mechanism of action of cryolipolysis is believed to involve selective crystallization of lipids in fat cells at temperatures near freezing. "Apoptotic fat cell death is followed by slow dissolution of the fat cell and a gradual release of lipids," Dr. Avram explained. "The inflammatory process results in fat layer reduction over 2-4 months."

When human studies of the technology were first conducted in 2008, enrollment was restricted to 32 patients whose "love handles" were treated at a cooling intensity factor (CIF) of 33 for 60 minutes, and progressed to higher rates of energy extractions for 45 minutes per application site. One side was treated; the untreated contralateral side served as the control.

Efficacy was evaluated at 4 months post treatment via visual assessment as a primary end point, as well as ultrasound and histology. The ultrasound results demonstrated an average 23% decrease in fat layer thickness.

"In this initial group of 32 love handle patients treated once, discernible changes were seen on the treated side vs. baseline of the treated side, and compared to the untreated contralateral control," Dr. Avram said of the findings presented during a poster session at the 2008 annual meeting of the American Society for Dermatologic Surgery. "This unique study design [using each patient as his or her own control], provided very powerful evidence that this was a true treatment effect rather than a change in the patient's diet or exercise pattern during the 4 months after this single procedure exposure."

Common effects after cryolipolysis include redness, which lasts minutes to a few hours; bruising, which may last for a few weeks; and temporary dulling of sensation in the treated area, which typically resolves in 1-8 weeks. No postprocedural changes in pigmentation or laboratory abnormalities have been observed, he said.

About 1 in 2,000 patients experiences severe pain beginning 3-7 days post treatment, which translates into 26 reported cases out of 60,000 treatments. "We are not sure why these occur, but these cases completely resolve with no sequelae," Dr. Avram said.

He emphasized that cryolipolysis is not a replacement for liposuction. "It is not a weight-loss device," he said. "It's best suited for local fat removal resistant to exercise in relatively fit patients."

Dr. Avram disclosed holding stock options in Zeltiq Aesthetics, which manufactures cryolipolysis equipment. SDEF and this news organization are owned by Elsevier.