2011 South Beach Symposium

MIAMI BEACH – An antibiotic-coated monofilament suture provides strength, flexibility, and elasticity for dermatologic surgery, but requires an extra throw to prevent knot slippage and comes with an initial learning curve, Dr. Susan H. Weinkle said.

"I’ve been using the same sutures almost 30 years until about 9 months ago," Dr. Weinkle said at this year’s South Beach Symposium.

The Monocryl Plus (poliglecaprone 25, Ethicon) is an absorbable, monofilament suture coated with triclosan antibiotic. The antibiotic "is the plus" and it can lower wound closing costs, Dr. Weinkle said.

The suture can be buried or it can run along the surface of the skin, Dr. Weinkle said. This product is associated with low tissue reactivity, so you get wounds with very little inflammation. "If someone cannot get back to my office quickly enough for suture removal, there [still] is very little reaction."

Absorption of the suture begins in about 12 days and can take considerably longer. "That’s a good thing. It stays underneath for up to 120 days, which is longer than Vicryl would last," Dr. Weinkle said. "However, (the sutures) don’t absorb fast enough on the skin. You still need to see the patient back." She asks patients to return to check wound healing anyway, especially to rule out any hematoma "because everyone I do surgery on is on (a blood thinner)."

"When I sew with Vicryl (polyglactin 910 suture, Ethicon), I tend to only put three knots in the wound. Two throws to start, and then another one on top of that." With this monofilament suture, a fourth throw is generally required to secure the knot, Dr. Weinkle said.

Wound infection risk generally is lower with a monofilament suture. In contrast, although easier to use, braided or twisted multifilament sutures carry a higher infection risk. "In a braided suture you have many more areas for fluid and bacteria to get in – that is very important."

There is an initial learning curve with this monofilament suture and "you are not going to love it in the beginning," said Dr. Weinkle, a private practice dermatologist and Mohs surgeon in Bradenton, Fla. "I sent some of these to a colleague in town and he did not like them." She added: "That is only because he tried one pack. You need at least eight packages until you can actually bond with this suture."

This suture features good elasticity, an imperative for wounds where a lot of local anesthesia was injected and edema results when the wound is closed. The suture stretches, and when that edema dissipates, the suture needs to come back down, she explained.

Using one monofilament suture compared to a two-suture closure can save costs, Dr. Weinkle said. The cost of one monofilament suture to close both deeply and superficially is about $12, compared with almost $18 to use a combination of Vicryl and nylon sutures. "Say you work 48 weeks a year and you do 30 incisions a week." Save $6 on each of these 1,440 annual wound closures "and you're looking at a savings of $8,640."

How you buy this suture is also important, Dr. Weinkle said. "I have a low overhead because I check the prices." Multiple national distributors carry this suture. "Make sure whoever you are buying from knows you’re a surgeon. Otherwise, you may end up paying more money for the same packet of sutures because you’re a dermatologist – you're a different category," Dr. Weinkle said. Also consider joining a group purchasing organization.

"Talk to your rep, say you'd like some samples, and say you'll need at least eight packs," Dr. Weinkle said. "I'm telling you, this is going to save you money and do an even better job for your patients."

Dr. Weinkle said that she did not have any relevant financial disclosures.

MIAMI BEACH – An antibiotic-coated monofilament suture provides strength, flexibility, and elasticity for dermatologic surgery, but requires an extra throw to prevent knot slippage and comes with an initial learning curve, Dr. Susan H. Weinkle said.

"I’ve been using the same sutures almost 30 years until about 9 months ago," Dr. Weinkle said at this year’s South Beach Symposium.

The Monocryl Plus (poliglecaprone 25, Ethicon) is an absorbable, monofilament suture coated with triclosan antibiotic. The antibiotic "is the plus" and it can lower wound closing costs, Dr. Weinkle said.

The suture can be buried or it can run along the surface of the skin, Dr. Weinkle said. This product is associated with low tissue reactivity, so you get wounds with very little inflammation. "If someone cannot get back to my office quickly enough for suture removal, there [still] is very little reaction."

Absorption of the suture begins in about 12 days and can take considerably longer. "That’s a good thing. It stays underneath for up to 120 days, which is longer than Vicryl would last," Dr. Weinkle said. "However, (the sutures) don’t absorb fast enough on the skin. You still need to see the patient back." She asks patients to return to check wound healing anyway, especially to rule out any hematoma "because everyone I do surgery on is on (a blood thinner)."

"When I sew with Vicryl (polyglactin 910 suture, Ethicon), I tend to only put three knots in the wound. Two throws to start, and then another one on top of that." With this monofilament suture, a fourth throw is generally required to secure the knot, Dr. Weinkle said.

Wound infection risk generally is lower with a monofilament suture. In contrast, although easier to use, braided or twisted multifilament sutures carry a higher infection risk. "In a braided suture you have many more areas for fluid and bacteria to get in – that is very important."

There is an initial learning curve with this monofilament suture and "you are not going to love it in the beginning," said Dr. Weinkle, a private practice dermatologist and Mohs surgeon in Bradenton, Fla. "I sent some of these to a colleague in town and he did not like them." She added: "That is only because he tried one pack. You need at least eight packages until you can actually bond with this suture."

This suture features good elasticity, an imperative for wounds where a lot of local anesthesia was injected and edema results when the wound is closed. The suture stretches, and when that edema dissipates, the suture needs to come back down, she explained.

Using one monofilament suture compared to a two-suture closure can save costs, Dr. Weinkle said. The cost of one monofilament suture to close both deeply and superficially is about $12, compared with almost $18 to use a combination of Vicryl and nylon sutures. "Say you work 48 weeks a year and you do 30 incisions a week." Save $6 on each of these 1,440 annual wound closures "and you're looking at a savings of $8,640."

How you buy this suture is also important, Dr. Weinkle said. "I have a low overhead because I check the prices." Multiple national distributors carry this suture. "Make sure whoever you are buying from knows you’re a surgeon. Otherwise, you may end up paying more money for the same packet of sutures because you’re a dermatologist – you're a different category," Dr. Weinkle said. Also consider joining a group purchasing organization.

"Talk to your rep, say you'd like some samples, and say you'll need at least eight packs," Dr. Weinkle said. "I'm telling you, this is going to save you money and do an even better job for your patients."

Dr. Weinkle said that she did not have any relevant financial disclosures.

MIAMI BEACH – An antibiotic-coated monofilament suture provides strength, flexibility, and elasticity for dermatologic surgery, but requires an extra throw to prevent knot slippage and comes with an initial learning curve, Dr. Susan H. Weinkle said.

"I’ve been using the same sutures almost 30 years until about 9 months ago," Dr. Weinkle said at this year’s South Beach Symposium.

The Monocryl Plus (poliglecaprone 25, Ethicon) is an absorbable, monofilament suture coated with triclosan antibiotic. The antibiotic "is the plus" and it can lower wound closing costs, Dr. Weinkle said.

The suture can be buried or it can run along the surface of the skin, Dr. Weinkle said. This product is associated with low tissue reactivity, so you get wounds with very little inflammation. "If someone cannot get back to my office quickly enough for suture removal, there [still] is very little reaction."

Absorption of the suture begins in about 12 days and can take considerably longer. "That’s a good thing. It stays underneath for up to 120 days, which is longer than Vicryl would last," Dr. Weinkle said. "However, (the sutures) don’t absorb fast enough on the skin. You still need to see the patient back." She asks patients to return to check wound healing anyway, especially to rule out any hematoma "because everyone I do surgery on is on (a blood thinner)."

"When I sew with Vicryl (polyglactin 910 suture, Ethicon), I tend to only put three knots in the wound. Two throws to start, and then another one on top of that." With this monofilament suture, a fourth throw is generally required to secure the knot, Dr. Weinkle said.

Wound infection risk generally is lower with a monofilament suture. In contrast, although easier to use, braided or twisted multifilament sutures carry a higher infection risk. "In a braided suture you have many more areas for fluid and bacteria to get in – that is very important."

There is an initial learning curve with this monofilament suture and "you are not going to love it in the beginning," said Dr. Weinkle, a private practice dermatologist and Mohs surgeon in Bradenton, Fla. "I sent some of these to a colleague in town and he did not like them." She added: "That is only because he tried one pack. You need at least eight packages until you can actually bond with this suture."

This suture features good elasticity, an imperative for wounds where a lot of local anesthesia was injected and edema results when the wound is closed. The suture stretches, and when that edema dissipates, the suture needs to come back down, she explained.

Using one monofilament suture compared to a two-suture closure can save costs, Dr. Weinkle said. The cost of one monofilament suture to close both deeply and superficially is about $12, compared with almost $18 to use a combination of Vicryl and nylon sutures. "Say you work 48 weeks a year and you do 30 incisions a week." Save $6 on each of these 1,440 annual wound closures "and you're looking at a savings of $8,640."

How you buy this suture is also important, Dr. Weinkle said. "I have a low overhead because I check the prices." Multiple national distributors carry this suture. "Make sure whoever you are buying from knows you’re a surgeon. Otherwise, you may end up paying more money for the same packet of sutures because you’re a dermatologist – you're a different category," Dr. Weinkle said. Also consider joining a group purchasing organization.

"Talk to your rep, say you'd like some samples, and say you'll need at least eight packs," Dr. Weinkle said. "I'm telling you, this is going to save you money and do an even better job for your patients."

Dr. Weinkle said that she did not have any relevant financial disclosures.

MIAMI BEACH – A 4% topical lidocaine cream with a nanotechnology-based vehicle in development provided superior pain relief before facial filler injections, compared with the most commonly-used topical anesthetic cream, according to patient and physician ratings in two split-face studies.

"This really has potential as the next topical anesthetic," Dr. Glynis Ablon said at the South Beach Symposium.

Although most dermatologists and pediatricians apply topical anesthetic products (such as commonly used LMX4 cream) approximately 20 minutes before needle-based procedures, the efficacy of NTL4 (Cutiecaine Cream) was seen in as little as 5 minutes, Dr. Ablon said.

NTL4 is formulated with a novel nanoparticle vehicle (INParT Drug Delivery System) that passively transports active compounds deeper into the skin. "It's a great new way to deliver lidocaine into the skin faster," said Dr. Ablon, a dermatologist in private practice in Manhattan Beach, Calif. The technology is also being assessed for new topical hyaluronic acid and topical botulinum toxins.

Dr. Ablon and her colleague Dr. Mark Nestor, who is in private practice in Aventura, Fla., conducted an initial study of 30 patients with NTL4 applied to one side of their face and over-the-counter LMX4 to the contralateral side, followed by a 20-second massage. After 20 minutes, Restylane was injected for facial rejuvenation. Participants and blinded raters assessed pain relief.

"The study was started to see if we could get that [numbing effect] in 20 minutes, and obviously faster numbing times could be a great thing for dermatologists as well as pediatricians," Dr. Ablon said.

Twenty patients (67%) reported minimal or no pain when injected on the NTL4 side of their face, compared with 12 patients (40%) who reported minimal or no pain on the LMX4 treated side. "Overall, patients significantly preferred treatment with NTL4 over LMX4," she said. The mean visual analog score (VAS) for pain was 1.99 in the NTL4 group vs. 3.08 in the LMX4 group immediately after injection; 0.21 vs. 0.74 at 1 hour; and 0.07 and 0.31 at 3 hours postinjection.

Blinded investigators also rated significantly less pain with NTL4, Dr. Ablon said.

Adverse events were minor and included some tenderness and bruising. Also, there was "some edema we believe was due to the actual injection of the Restylane."

In a second study, Dr. Ablon and Dr. Nestor assessed 5-, 10-, and 15-minute application times. The 20 participants had a 30-second massage of the topical anesthetic and subsequent Restylane injections of their nasolabial folds.

Sixteen patients (80%) treated with NTL4 reported minimal or no pain, compared with one patient (5%) treated with LMX4, according to pooled data for subjective pain ratings after 5-, 10-, and 15-minute application times.

"We did show that they had significantly less pain on injection with the NTL4 at the 5- and 15-minute incubation, with a trend favoring it at 10 minutes," Dr. Ablon said.

Mean VAS pain scores were significantly lower for the NTL4 group when injected 5 minutes after application: 1.72 for NTL4 vs. 4.20 for LMX4. Patients also reported a significant difference in pain when injected 15 minutes after injection: 1.92 with NTL4 vs. 4.67 with LMX4. There was a nonsignificant trend favoring lower VAS scores with NTL4 after a 10-minute application time(1.08 for NTL4 and 3.00 for LMX4).

All patients preferred the NTL4 side versus the LMX4 side for pain relief. Blinded investigators’ evaluation of pain was also statistically significant in favor of the NTL4, Dr. Ablon said.

Adverse events were minor in this study as well. "We did have one patient with edema that we think might have been an actual reaction to lidocaine," she noted.

"There is a lot going on with nanotechnology, and [it] is here to stay," Dr. Ablon said. This technology can be found in suntan lotions, age-defying makeup, and even toothpaste that coats damaged enamel.

The studies were funded through an unrestricted educational grant from Innovatech. Dr. Ablon and Dr. Nestor are consultants and investigators for Transdermal Corp.

MIAMI BEACH – A 4% topical lidocaine cream with a nanotechnology-based vehicle in development provided superior pain relief before facial filler injections, compared with the most commonly-used topical anesthetic cream, according to patient and physician ratings in two split-face studies.

"This really has potential as the next topical anesthetic," Dr. Glynis Ablon said at the South Beach Symposium.

Although most dermatologists and pediatricians apply topical anesthetic products (such as commonly used LMX4 cream) approximately 20 minutes before needle-based procedures, the efficacy of NTL4 (Cutiecaine Cream) was seen in as little as 5 minutes, Dr. Ablon said.

NTL4 is formulated with a novel nanoparticle vehicle (INParT Drug Delivery System) that passively transports active compounds deeper into the skin. "It's a great new way to deliver lidocaine into the skin faster," said Dr. Ablon, a dermatologist in private practice in Manhattan Beach, Calif. The technology is also being assessed for new topical hyaluronic acid and topical botulinum toxins.

Dr. Ablon and her colleague Dr. Mark Nestor, who is in private practice in Aventura, Fla., conducted an initial study of 30 patients with NTL4 applied to one side of their face and over-the-counter LMX4 to the contralateral side, followed by a 20-second massage. After 20 minutes, Restylane was injected for facial rejuvenation. Participants and blinded raters assessed pain relief.

"The study was started to see if we could get that [numbing effect] in 20 minutes, and obviously faster numbing times could be a great thing for dermatologists as well as pediatricians," Dr. Ablon said.

Twenty patients (67%) reported minimal or no pain when injected on the NTL4 side of their face, compared with 12 patients (40%) who reported minimal or no pain on the LMX4 treated side. "Overall, patients significantly preferred treatment with NTL4 over LMX4," she said. The mean visual analog score (VAS) for pain was 1.99 in the NTL4 group vs. 3.08 in the LMX4 group immediately after injection; 0.21 vs. 0.74 at 1 hour; and 0.07 and 0.31 at 3 hours postinjection.

Blinded investigators also rated significantly less pain with NTL4, Dr. Ablon said.

Adverse events were minor and included some tenderness and bruising. Also, there was "some edema we believe was due to the actual injection of the Restylane."

In a second study, Dr. Ablon and Dr. Nestor assessed 5-, 10-, and 15-minute application times. The 20 participants had a 30-second massage of the topical anesthetic and subsequent Restylane injections of their nasolabial folds.

Sixteen patients (80%) treated with NTL4 reported minimal or no pain, compared with one patient (5%) treated with LMX4, according to pooled data for subjective pain ratings after 5-, 10-, and 15-minute application times.

"We did show that they had significantly less pain on injection with the NTL4 at the 5- and 15-minute incubation, with a trend favoring it at 10 minutes," Dr. Ablon said.

Mean VAS pain scores were significantly lower for the NTL4 group when injected 5 minutes after application: 1.72 for NTL4 vs. 4.20 for LMX4. Patients also reported a significant difference in pain when injected 15 minutes after injection: 1.92 with NTL4 vs. 4.67 with LMX4. There was a nonsignificant trend favoring lower VAS scores with NTL4 after a 10-minute application time(1.08 for NTL4 and 3.00 for LMX4).

All patients preferred the NTL4 side versus the LMX4 side for pain relief. Blinded investigators’ evaluation of pain was also statistically significant in favor of the NTL4, Dr. Ablon said.

Adverse events were minor in this study as well. "We did have one patient with edema that we think might have been an actual reaction to lidocaine," she noted.

"There is a lot going on with nanotechnology, and [it] is here to stay," Dr. Ablon said. This technology can be found in suntan lotions, age-defying makeup, and even toothpaste that coats damaged enamel.

The studies were funded through an unrestricted educational grant from Innovatech. Dr. Ablon and Dr. Nestor are consultants and investigators for Transdermal Corp.

MIAMI BEACH – A 4% topical lidocaine cream with a nanotechnology-based vehicle in development provided superior pain relief before facial filler injections, compared with the most commonly-used topical anesthetic cream, according to patient and physician ratings in two split-face studies.

"This really has potential as the next topical anesthetic," Dr. Glynis Ablon said at the South Beach Symposium.

Although most dermatologists and pediatricians apply topical anesthetic products (such as commonly used LMX4 cream) approximately 20 minutes before needle-based procedures, the efficacy of NTL4 (Cutiecaine Cream) was seen in as little as 5 minutes, Dr. Ablon said.

NTL4 is formulated with a novel nanoparticle vehicle (INParT Drug Delivery System) that passively transports active compounds deeper into the skin. "It's a great new way to deliver lidocaine into the skin faster," said Dr. Ablon, a dermatologist in private practice in Manhattan Beach, Calif. The technology is also being assessed for new topical hyaluronic acid and topical botulinum toxins.

Dr. Ablon and her colleague Dr. Mark Nestor, who is in private practice in Aventura, Fla., conducted an initial study of 30 patients with NTL4 applied to one side of their face and over-the-counter LMX4 to the contralateral side, followed by a 20-second massage. After 20 minutes, Restylane was injected for facial rejuvenation. Participants and blinded raters assessed pain relief.

"The study was started to see if we could get that [numbing effect] in 20 minutes, and obviously faster numbing times could be a great thing for dermatologists as well as pediatricians," Dr. Ablon said.

Twenty patients (67%) reported minimal or no pain when injected on the NTL4 side of their face, compared with 12 patients (40%) who reported minimal or no pain on the LMX4 treated side. "Overall, patients significantly preferred treatment with NTL4 over LMX4," she said. The mean visual analog score (VAS) for pain was 1.99 in the NTL4 group vs. 3.08 in the LMX4 group immediately after injection; 0.21 vs. 0.74 at 1 hour; and 0.07 and 0.31 at 3 hours postinjection.

Blinded investigators also rated significantly less pain with NTL4, Dr. Ablon said.

Adverse events were minor and included some tenderness and bruising. Also, there was "some edema we believe was due to the actual injection of the Restylane."

In a second study, Dr. Ablon and Dr. Nestor assessed 5-, 10-, and 15-minute application times. The 20 participants had a 30-second massage of the topical anesthetic and subsequent Restylane injections of their nasolabial folds.

Sixteen patients (80%) treated with NTL4 reported minimal or no pain, compared with one patient (5%) treated with LMX4, according to pooled data for subjective pain ratings after 5-, 10-, and 15-minute application times.

"We did show that they had significantly less pain on injection with the NTL4 at the 5- and 15-minute incubation, with a trend favoring it at 10 minutes," Dr. Ablon said.

Mean VAS pain scores were significantly lower for the NTL4 group when injected 5 minutes after application: 1.72 for NTL4 vs. 4.20 for LMX4. Patients also reported a significant difference in pain when injected 15 minutes after injection: 1.92 with NTL4 vs. 4.67 with LMX4. There was a nonsignificant trend favoring lower VAS scores with NTL4 after a 10-minute application time(1.08 for NTL4 and 3.00 for LMX4).

All patients preferred the NTL4 side versus the LMX4 side for pain relief. Blinded investigators’ evaluation of pain was also statistically significant in favor of the NTL4, Dr. Ablon said.

Adverse events were minor in this study as well. "We did have one patient with edema that we think might have been an actual reaction to lidocaine," she noted.

"There is a lot going on with nanotechnology, and [it] is here to stay," Dr. Ablon said. This technology can be found in suntan lotions, age-defying makeup, and even toothpaste that coats damaged enamel.

The studies were funded through an unrestricted educational grant from Innovatech. Dr. Ablon and Dr. Nestor are consultants and investigators for Transdermal Corp.

MIAMI BEACH – Lipolysis with proprietary sodium deoxycholate injections significantly decreased the volume of submental fat in a randomized, vehicle-control, phase IIb study.

Investigators at 10 sites in the United States randomized 129 patients with moderate-to-severe "submental convexity" to low-dose or high-dose sodium deoxycholate (ATX-101, Kythera Biopharmaceuticals) or placebo. Administration was once a month for up to 5 months, Dr. Patricia S. Walker said at the South Beach Symposium.

Patients and clinicians rated changes at 16 weeks and 3 months after the final treatment, compared with baseline. At the same time, investigators also compared MRI volume measurements as an objective measure of fat changes.

MRI revealed significant reductions in submental fat at week 16 and week 32 from baseline, compared with placebo, for patients randomized to 2 mg/cm² sodium deoxycholate (the high-dose group).

Seven dermatologists and three plastic surgeons at the 10 sites treated the participants and performed global assessments. The clinicians rated changes using a 5-point Clinician-Reported Submental Fat Impact Scale.

Again, the 2-mg/cm² dose was more efficacious than placebo, with statistically significant reductions rated by doctors at week 16 and week 32. Although the effect on patients who received the 1-mg/cm² dose (low-dose group) did not reach significance, this dose was also associated with improvement compared with placebo, suggesting a dose response, Dr. Walker said.

Patients also rated their own changes in submental fat using a 5-point Patient-Reported Submental Fat Impact Scale at baseline, week 16, and week 32.

Interestingly, all patients reported subjective improvements compared with baseline – even those assigned to vehicle-only injections. "Patients have a perception of self-improvement," Dr. Walker said. "There was very little change on MRI in the vehicle group, so it’s a true placebo effect – patients want to see a response."

Sodium deoxycholate selectively targets adipocytes. Histology showed infiltration of macrophages by day 3, with destruction and clearance of fat over time. "Twenty-eight days is about the right time for these injections to clear fat," said Dr. Walker, who is chief medical officer for Kythera Biopharmaceuticals.

Sodium deoxycholate is an endogenous, secondary bile acid. This is "how we break down fat in our diet," Dr. Walker said.

A total 114 patients completed the study. Fitzpatrick skin types ranged from I to VI, average age was 46 years (range 24-65 years), and the mean body mass index was 30.6 kg/m² (range 19.5-48.8). "We found chin fat is not necessarily related to [body] size. It can be familial," Dr. Walker said.

Most adverse events were mild, transient, and limited to the chin area. "If you don’t have a safe product, you don’t have an aesthetic product," she said.

Treatment-related swelling, pain, and numbness were the most common adverse events. "There also was erythema in the vehicle group, so it was probably injection-technique related."

ATX-101 is a safe and effective treatment for submental fat reduction, Dr. Walker said. "It is nice to have an aesthetic product that everyone sees works."

Phase III trials are planned this year, according to Kythera Biopharmaceuticals.

Dr. Walker is an employee and shareholder of the company.

MIAMI BEACH – Lipolysis with proprietary sodium deoxycholate injections significantly decreased the volume of submental fat in a randomized, vehicle-control, phase IIb study.

Investigators at 10 sites in the United States randomized 129 patients with moderate-to-severe "submental convexity" to low-dose or high-dose sodium deoxycholate (ATX-101, Kythera Biopharmaceuticals) or placebo. Administration was once a month for up to 5 months, Dr. Patricia S. Walker said at the South Beach Symposium.

Patients and clinicians rated changes at 16 weeks and 3 months after the final treatment, compared with baseline. At the same time, investigators also compared MRI volume measurements as an objective measure of fat changes.

MRI revealed significant reductions in submental fat at week 16 and week 32 from baseline, compared with placebo, for patients randomized to 2 mg/cm² sodium deoxycholate (the high-dose group).

Seven dermatologists and three plastic surgeons at the 10 sites treated the participants and performed global assessments. The clinicians rated changes using a 5-point Clinician-Reported Submental Fat Impact Scale.

Again, the 2-mg/cm² dose was more efficacious than placebo, with statistically significant reductions rated by doctors at week 16 and week 32. Although the effect on patients who received the 1-mg/cm² dose (low-dose group) did not reach significance, this dose was also associated with improvement compared with placebo, suggesting a dose response, Dr. Walker said.

Patients also rated their own changes in submental fat using a 5-point Patient-Reported Submental Fat Impact Scale at baseline, week 16, and week 32.

Interestingly, all patients reported subjective improvements compared with baseline – even those assigned to vehicle-only injections. "Patients have a perception of self-improvement," Dr. Walker said. "There was very little change on MRI in the vehicle group, so it’s a true placebo effect – patients want to see a response."

Sodium deoxycholate selectively targets adipocytes. Histology showed infiltration of macrophages by day 3, with destruction and clearance of fat over time. "Twenty-eight days is about the right time for these injections to clear fat," said Dr. Walker, who is chief medical officer for Kythera Biopharmaceuticals.

Sodium deoxycholate is an endogenous, secondary bile acid. This is "how we break down fat in our diet," Dr. Walker said.

A total 114 patients completed the study. Fitzpatrick skin types ranged from I to VI, average age was 46 years (range 24-65 years), and the mean body mass index was 30.6 kg/m² (range 19.5-48.8). "We found chin fat is not necessarily related to [body] size. It can be familial," Dr. Walker said.

Most adverse events were mild, transient, and limited to the chin area. "If you don’t have a safe product, you don’t have an aesthetic product," she said.

Treatment-related swelling, pain, and numbness were the most common adverse events. "There also was erythema in the vehicle group, so it was probably injection-technique related."

ATX-101 is a safe and effective treatment for submental fat reduction, Dr. Walker said. "It is nice to have an aesthetic product that everyone sees works."

Phase III trials are planned this year, according to Kythera Biopharmaceuticals.

Dr. Walker is an employee and shareholder of the company.

MIAMI BEACH – Lipolysis with proprietary sodium deoxycholate injections significantly decreased the volume of submental fat in a randomized, vehicle-control, phase IIb study.

Investigators at 10 sites in the United States randomized 129 patients with moderate-to-severe "submental convexity" to low-dose or high-dose sodium deoxycholate (ATX-101, Kythera Biopharmaceuticals) or placebo. Administration was once a month for up to 5 months, Dr. Patricia S. Walker said at the South Beach Symposium.

Patients and clinicians rated changes at 16 weeks and 3 months after the final treatment, compared with baseline. At the same time, investigators also compared MRI volume measurements as an objective measure of fat changes.

MRI revealed significant reductions in submental fat at week 16 and week 32 from baseline, compared with placebo, for patients randomized to 2 mg/cm² sodium deoxycholate (the high-dose group).

Seven dermatologists and three plastic surgeons at the 10 sites treated the participants and performed global assessments. The clinicians rated changes using a 5-point Clinician-Reported Submental Fat Impact Scale.

Again, the 2-mg/cm² dose was more efficacious than placebo, with statistically significant reductions rated by doctors at week 16 and week 32. Although the effect on patients who received the 1-mg/cm² dose (low-dose group) did not reach significance, this dose was also associated with improvement compared with placebo, suggesting a dose response, Dr. Walker said.

Patients also rated their own changes in submental fat using a 5-point Patient-Reported Submental Fat Impact Scale at baseline, week 16, and week 32.

Interestingly, all patients reported subjective improvements compared with baseline – even those assigned to vehicle-only injections. "Patients have a perception of self-improvement," Dr. Walker said. "There was very little change on MRI in the vehicle group, so it’s a true placebo effect – patients want to see a response."

Sodium deoxycholate selectively targets adipocytes. Histology showed infiltration of macrophages by day 3, with destruction and clearance of fat over time. "Twenty-eight days is about the right time for these injections to clear fat," said Dr. Walker, who is chief medical officer for Kythera Biopharmaceuticals.

Sodium deoxycholate is an endogenous, secondary bile acid. This is "how we break down fat in our diet," Dr. Walker said.

A total 114 patients completed the study. Fitzpatrick skin types ranged from I to VI, average age was 46 years (range 24-65 years), and the mean body mass index was 30.6 kg/m² (range 19.5-48.8). "We found chin fat is not necessarily related to [body] size. It can be familial," Dr. Walker said.

Most adverse events were mild, transient, and limited to the chin area. "If you don’t have a safe product, you don’t have an aesthetic product," she said.

Treatment-related swelling, pain, and numbness were the most common adverse events. "There also was erythema in the vehicle group, so it was probably injection-technique related."

ATX-101 is a safe and effective treatment for submental fat reduction, Dr. Walker said. "It is nice to have an aesthetic product that everyone sees works."

Phase III trials are planned this year, according to Kythera Biopharmaceuticals.

Dr. Walker is an employee and shareholder of the company.

MIAMI BEACH – Sublative skin rejuvenation is a resurfacing technology that seeks to provide the best of both worlds – efficacy closer to more intensive ablative procedures and an adverse event profile more akin to gentler, nonablative techniques.

Sublative rejuvenation can be performed on the full face, with good results around the eyes and the neck, Dr. Robert A. Weiss said at the symposium.

"We've gotten some very nice skin contraction and smoothing in the periorbital area," he said.

The fractional radiofrequency eMatrix system (Syneron) offers deep volumetric heating into the dermis with minimal epidermal disruption, said Dr. Weiss, director of the Maryland Laser, Skin, and Vein Institute in Hunt Valley. Subsequent dermal remodeling with minimal downtime are other advantages of this treatment.

The Food and Drug Administration cleared marketing of the applicator for use in dermatologic procedures requiring ablation of soft tissue and skin resurfacing.

The device tip is a grid of negatively- and positively-charged electrodes between which bipolar radiofrequency energy flows. The current can be controlled and varied depending on individual patient factors. Because this is a fractional technology, intact tissue is left between the electrode pins to speed healing and recovery.

The standard protocol is three to four treatment sessions spaced 4-6 weeks apart. Touch-up sessions, as indicated, are generally every 6 months or so.

The full face can be treated in 20 minutes, said Dr. Weiss, also of the department of dermatology at Johns Hopkins University, Baltimore. Improvements in acne scarring and wrinkles can be observed as well.

Ask patients to return 2-3 days after treatment to check for any adverse events, he said. Postoperative discomfort, significant pain, erythema, edema, and pigmentary changes can arise in the short or long term. Patient discomfort is usually tolerable and can be managed with topical anesthetics.

Postprocedure redness with nonablative techniques typically lasts a few hours to 1-2 days; with ablative procedures, 5-7 days (and sometimes up to 10 days); and with sublative treatment, a patient will have red dots on their skin and redness that lasts for a day or 2, Dr. Weiss said. "So it's really somewhere in the middle between ablative and nonablative."

Contraindications include any facelift or eyelid surgery 1 year prior to sublative resurfacing; injections of botulinum toxin, collagen, or fat (or any biomaterial augmentation) within the last 6 months; and any facial dermabrasion, resurfacing, or deep chemical peeling within the last 3 months.

Treat a hidden test spot to gauge individual response prior to full treatment, Dr. Weiss recommended. Gauge response after 24-48 hours for skin types I-III and 5-7 days for skin types IV-VI to ensure safety.

Cold packs or Synercool (Syneron) can be used immediately after treatment to cool the area if patients are uncomfortable. Advise patients to apply emollient cream and to use at least 30 SPF or greater sunscreen for at least a month.

"It's a promising technology, and I think we will know more a year from now," Dr. Weiss said.

He is a researcher for Syneron and received some initial free use of equipment.

MIAMI BEACH – Sublative skin rejuvenation is a resurfacing technology that seeks to provide the best of both worlds – efficacy closer to more intensive ablative procedures and an adverse event profile more akin to gentler, nonablative techniques.

Sublative rejuvenation can be performed on the full face, with good results around the eyes and the neck, Dr. Robert A. Weiss said at the symposium.

"We've gotten some very nice skin contraction and smoothing in the periorbital area," he said.

The fractional radiofrequency eMatrix system (Syneron) offers deep volumetric heating into the dermis with minimal epidermal disruption, said Dr. Weiss, director of the Maryland Laser, Skin, and Vein Institute in Hunt Valley. Subsequent dermal remodeling with minimal downtime are other advantages of this treatment.

The Food and Drug Administration cleared marketing of the applicator for use in dermatologic procedures requiring ablation of soft tissue and skin resurfacing.

The device tip is a grid of negatively- and positively-charged electrodes between which bipolar radiofrequency energy flows. The current can be controlled and varied depending on individual patient factors. Because this is a fractional technology, intact tissue is left between the electrode pins to speed healing and recovery.

The standard protocol is three to four treatment sessions spaced 4-6 weeks apart. Touch-up sessions, as indicated, are generally every 6 months or so.

The full face can be treated in 20 minutes, said Dr. Weiss, also of the department of dermatology at Johns Hopkins University, Baltimore. Improvements in acne scarring and wrinkles can be observed as well.

Ask patients to return 2-3 days after treatment to check for any adverse events, he said. Postoperative discomfort, significant pain, erythema, edema, and pigmentary changes can arise in the short or long term. Patient discomfort is usually tolerable and can be managed with topical anesthetics.

Postprocedure redness with nonablative techniques typically lasts a few hours to 1-2 days; with ablative procedures, 5-7 days (and sometimes up to 10 days); and with sublative treatment, a patient will have red dots on their skin and redness that lasts for a day or 2, Dr. Weiss said. "So it's really somewhere in the middle between ablative and nonablative."

Contraindications include any facelift or eyelid surgery 1 year prior to sublative resurfacing; injections of botulinum toxin, collagen, or fat (or any biomaterial augmentation) within the last 6 months; and any facial dermabrasion, resurfacing, or deep chemical peeling within the last 3 months.

Treat a hidden test spot to gauge individual response prior to full treatment, Dr. Weiss recommended. Gauge response after 24-48 hours for skin types I-III and 5-7 days for skin types IV-VI to ensure safety.

Cold packs or Synercool (Syneron) can be used immediately after treatment to cool the area if patients are uncomfortable. Advise patients to apply emollient cream and to use at least 30 SPF or greater sunscreen for at least a month.

"It's a promising technology, and I think we will know more a year from now," Dr. Weiss said.

He is a researcher for Syneron and received some initial free use of equipment.

MIAMI BEACH – Sublative skin rejuvenation is a resurfacing technology that seeks to provide the best of both worlds – efficacy closer to more intensive ablative procedures and an adverse event profile more akin to gentler, nonablative techniques.

Sublative rejuvenation can be performed on the full face, with good results around the eyes and the neck, Dr. Robert A. Weiss said at the symposium.

"We've gotten some very nice skin contraction and smoothing in the periorbital area," he said.

The fractional radiofrequency eMatrix system (Syneron) offers deep volumetric heating into the dermis with minimal epidermal disruption, said Dr. Weiss, director of the Maryland Laser, Skin, and Vein Institute in Hunt Valley. Subsequent dermal remodeling with minimal downtime are other advantages of this treatment.

The Food and Drug Administration cleared marketing of the applicator for use in dermatologic procedures requiring ablation of soft tissue and skin resurfacing.

The device tip is a grid of negatively- and positively-charged electrodes between which bipolar radiofrequency energy flows. The current can be controlled and varied depending on individual patient factors. Because this is a fractional technology, intact tissue is left between the electrode pins to speed healing and recovery.

The standard protocol is three to four treatment sessions spaced 4-6 weeks apart. Touch-up sessions, as indicated, are generally every 6 months or so.

The full face can be treated in 20 minutes, said Dr. Weiss, also of the department of dermatology at Johns Hopkins University, Baltimore. Improvements in acne scarring and wrinkles can be observed as well.

Ask patients to return 2-3 days after treatment to check for any adverse events, he said. Postoperative discomfort, significant pain, erythema, edema, and pigmentary changes can arise in the short or long term. Patient discomfort is usually tolerable and can be managed with topical anesthetics.

Postprocedure redness with nonablative techniques typically lasts a few hours to 1-2 days; with ablative procedures, 5-7 days (and sometimes up to 10 days); and with sublative treatment, a patient will have red dots on their skin and redness that lasts for a day or 2, Dr. Weiss said. "So it's really somewhere in the middle between ablative and nonablative."

Contraindications include any facelift or eyelid surgery 1 year prior to sublative resurfacing; injections of botulinum toxin, collagen, or fat (or any biomaterial augmentation) within the last 6 months; and any facial dermabrasion, resurfacing, or deep chemical peeling within the last 3 months.

Treat a hidden test spot to gauge individual response prior to full treatment, Dr. Weiss recommended. Gauge response after 24-48 hours for skin types I-III and 5-7 days for skin types IV-VI to ensure safety.

Cold packs or Synercool (Syneron) can be used immediately after treatment to cool the area if patients are uncomfortable. Advise patients to apply emollient cream and to use at least 30 SPF or greater sunscreen for at least a month.

"It's a promising technology, and I think we will know more a year from now," Dr. Weiss said.

He is a researcher for Syneron and received some initial free use of equipment.