Understanding Elastic Recoil Key to Aging Skin

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Understanding Elastic Recoil Key to Aging Skin
'Restoring skin elasticity is a better goal than tightening the skin.'

DANA POINT, CALIF. – Finding ways to restore elasticity of the skin is a better goal than is developing and refining ways to tighten the skin, according to Dr. R. Rox Anderson.

"The loss of natural skin tension with aging is due to a loss of its elasticity," Dr. Anderson said at the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF). "It’s the impressive loss of cutaneous elastic recoil with aging that accounts for the effectiveness of Botox, for example. A simple hypothesis is that restoring skin elasticity is a better goal than tightening the skin."

Dr. R. Rox Anderson    

The "players" in cutaneous elastic recoil, he said, are numerous, but it remains unknown which are pivotal. Is it the extracellular matrix content and cross-linking, the fibril microstructure, or the active cytoskeleton?

"When you lose elastic recoil, we don’t know which ones of these are most important," said Dr. Anderson, professor of dermatology at Harvard Medical School, Boston. "If we knew that, we could design treatments that actually treat the cause as opposed to [treating] flabby skin."

He said that "powerful, verified" research tools are needed to improve understanding of cutaneous elastic recoil, including "composite, dynamic structural models" to expand understanding of the difference between microscopic and macroscopic skin. "Those exist; we don’t have to invent them," he said. "I’m an adjunct professor at Massachusetts Institute of Technology, [which has] an entire department that does nothing but material science and modeling. They’re really good at composite materials. That’s what we [humans] are: we are complex composite material."

Stress-strain component analysis is another key tool to improve understanding of elastic recoil. "Each of those components has its own structural and dynamic behavior," said Dr. Anderson, who also directs the Wellman Center for Photomedicine. "I think it’s important to recognize that the skin is a dynamic system that responds to stress. So Langer’s lines are due to particular strain receptors and fibroblasts. The genes that are strain inducible have been at least partially noted, but they have not been studied in the context of skin tightening and rejuvenation. I would love to see that: a dose response analysis for strain-mediated gene expression."

Studies involving in vivo microscopy will also be important. "Elastin, for example, is easy as pie to image in vivo in human skin," he said. "We should be able to map mechanical properties of skin."

Dr. Anderson said that he had no relevant financial conflicts to disclose.

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'Restoring skin elasticity is a better goal than tightening the skin.'
'Restoring skin elasticity is a better goal than tightening the skin.'

DANA POINT, CALIF. – Finding ways to restore elasticity of the skin is a better goal than is developing and refining ways to tighten the skin, according to Dr. R. Rox Anderson.

"The loss of natural skin tension with aging is due to a loss of its elasticity," Dr. Anderson said at the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF). "It’s the impressive loss of cutaneous elastic recoil with aging that accounts for the effectiveness of Botox, for example. A simple hypothesis is that restoring skin elasticity is a better goal than tightening the skin."

Dr. R. Rox Anderson    

The "players" in cutaneous elastic recoil, he said, are numerous, but it remains unknown which are pivotal. Is it the extracellular matrix content and cross-linking, the fibril microstructure, or the active cytoskeleton?

"When you lose elastic recoil, we don’t know which ones of these are most important," said Dr. Anderson, professor of dermatology at Harvard Medical School, Boston. "If we knew that, we could design treatments that actually treat the cause as opposed to [treating] flabby skin."

He said that "powerful, verified" research tools are needed to improve understanding of cutaneous elastic recoil, including "composite, dynamic structural models" to expand understanding of the difference between microscopic and macroscopic skin. "Those exist; we don’t have to invent them," he said. "I’m an adjunct professor at Massachusetts Institute of Technology, [which has] an entire department that does nothing but material science and modeling. They’re really good at composite materials. That’s what we [humans] are: we are complex composite material."

Stress-strain component analysis is another key tool to improve understanding of elastic recoil. "Each of those components has its own structural and dynamic behavior," said Dr. Anderson, who also directs the Wellman Center for Photomedicine. "I think it’s important to recognize that the skin is a dynamic system that responds to stress. So Langer’s lines are due to particular strain receptors and fibroblasts. The genes that are strain inducible have been at least partially noted, but they have not been studied in the context of skin tightening and rejuvenation. I would love to see that: a dose response analysis for strain-mediated gene expression."

Studies involving in vivo microscopy will also be important. "Elastin, for example, is easy as pie to image in vivo in human skin," he said. "We should be able to map mechanical properties of skin."

Dr. Anderson said that he had no relevant financial conflicts to disclose.

DANA POINT, CALIF. – Finding ways to restore elasticity of the skin is a better goal than is developing and refining ways to tighten the skin, according to Dr. R. Rox Anderson.

"The loss of natural skin tension with aging is due to a loss of its elasticity," Dr. Anderson said at the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF). "It’s the impressive loss of cutaneous elastic recoil with aging that accounts for the effectiveness of Botox, for example. A simple hypothesis is that restoring skin elasticity is a better goal than tightening the skin."

Dr. R. Rox Anderson    

The "players" in cutaneous elastic recoil, he said, are numerous, but it remains unknown which are pivotal. Is it the extracellular matrix content and cross-linking, the fibril microstructure, or the active cytoskeleton?

"When you lose elastic recoil, we don’t know which ones of these are most important," said Dr. Anderson, professor of dermatology at Harvard Medical School, Boston. "If we knew that, we could design treatments that actually treat the cause as opposed to [treating] flabby skin."

He said that "powerful, verified" research tools are needed to improve understanding of cutaneous elastic recoil, including "composite, dynamic structural models" to expand understanding of the difference between microscopic and macroscopic skin. "Those exist; we don’t have to invent them," he said. "I’m an adjunct professor at Massachusetts Institute of Technology, [which has] an entire department that does nothing but material science and modeling. They’re really good at composite materials. That’s what we [humans] are: we are complex composite material."

Stress-strain component analysis is another key tool to improve understanding of elastic recoil. "Each of those components has its own structural and dynamic behavior," said Dr. Anderson, who also directs the Wellman Center for Photomedicine. "I think it’s important to recognize that the skin is a dynamic system that responds to stress. So Langer’s lines are due to particular strain receptors and fibroblasts. The genes that are strain inducible have been at least partially noted, but they have not been studied in the context of skin tightening and rejuvenation. I would love to see that: a dose response analysis for strain-mediated gene expression."

Studies involving in vivo microscopy will also be important. "Elastin, for example, is easy as pie to image in vivo in human skin," he said. "We should be able to map mechanical properties of skin."

Dr. Anderson said that he had no relevant financial conflicts to disclose.

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BMI Drives Body Contouring Results

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BMI Drives Body Contouring Results

DANA POINT, CALIF. – Three factors affect the results of body contouring outcomes after bariatric surgery: body mass index at presentation, fat deposition pattern, and quality of the skin-fat envelope, according to Dr. Al S. Aly.

"The fat deposition pattern is genetically controlled; we cannot alter that," Dr. Aly, professor and vice-chair of plastic surgery at the University of California, Irvine, said at the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF). "The quality of the skin-fat envelope is very important. If you have a very loose skin-fat envelope – meaning that they’ve had a tremendous drop in weight – you can do a lot more for them than with other patients."

Dr. Al S. Aly

The two main body contouring treatments for the lower trunk are abdominoplasty and circumferential belt lipectomy, said Dr. Aly. "Abdominoplasties are ideally suited for problems limited to the belly, or those located between the two anterior superior iliac spines. For larger patients you need to do something else."

The rehabilitation of larger patients involves a circumferential procedure commonly referred to as a body lift or belt lipectomy, which involves removing a circumferential wedge of tissue from around the trunk. "There are many reasons why we need circumferential excisions for these large patients, but the main one is that you need circumferential improvement above and below the area of resection as opposed to a regular tummy tuck," he explained.

Markings for the belt lipectomy "are the essence of the procedure," Dr. Aly said, who noted that about 10% of his patients are male. "The markings are adjustable guidelines, and they vary according to anatomy and desires. It’s a fairly complex set of issues but essentially you have to understand how tissues drape as the patient loses weight, and there are zones of adherence or areas of the body where the skin and the soft tissue envelope is stuck to the underlying musculoskeletal anatomy. It’s important to understand those before you can mark these patients. Surgical improvement is related to the amount of tension that you create above and below an area of excision."

Dr. Aly said that he routinely performs belt lipectomies with another surgeon and strives for surgical times under 6 hours. He uses a general anesthetic and an epidural for postoperative pain management. Moving patients into multiple positions during surgery is required, "otherwise you can’t accomplish the excisions," he said. "There is a variety of different approaches. Mine happens to be one of supine first then lateral/lateral."

Results of body contouring procedures generally correlate with the patient’s body mass index (BMI) at the time of surgery. "So people who present to us above a BMI of 35 kg/m2 ... their results are okay," he said. "Results are better for patients with a BMI of 30-35 kg/m2. If you’re lucky enough to get a patient at an ideal BMI – 26 kg/m2 and lower – then you can create almost normal anatomy."

He noted that, compared with abdominoplasties, results of belt lipectomies take longer than most procedures to mature. "However, their results are also far superior to those attainable with a tummy tuck," Dr. Aly said. Complications, including an increased risk for seroma and formation of hematoma, "correlate with BMI," he said. "If you’re not ready to deal with complications, massive weight loss patients are a tough group to deal with. It’s part of the nature of these patients."

Other areas that often need contouring include upper arm reductions, upper back roll reductions, reconstruction of the breasts (in women and men), and thigh reductions.

Dr. Aly said that he had no relevant conflicts to disclose. SDEF and this news organization are owned by Elsevier.

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DANA POINT, CALIF. – Three factors affect the results of body contouring outcomes after bariatric surgery: body mass index at presentation, fat deposition pattern, and quality of the skin-fat envelope, according to Dr. Al S. Aly.

"The fat deposition pattern is genetically controlled; we cannot alter that," Dr. Aly, professor and vice-chair of plastic surgery at the University of California, Irvine, said at the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF). "The quality of the skin-fat envelope is very important. If you have a very loose skin-fat envelope – meaning that they’ve had a tremendous drop in weight – you can do a lot more for them than with other patients."

Dr. Al S. Aly

The two main body contouring treatments for the lower trunk are abdominoplasty and circumferential belt lipectomy, said Dr. Aly. "Abdominoplasties are ideally suited for problems limited to the belly, or those located between the two anterior superior iliac spines. For larger patients you need to do something else."

The rehabilitation of larger patients involves a circumferential procedure commonly referred to as a body lift or belt lipectomy, which involves removing a circumferential wedge of tissue from around the trunk. "There are many reasons why we need circumferential excisions for these large patients, but the main one is that you need circumferential improvement above and below the area of resection as opposed to a regular tummy tuck," he explained.

Markings for the belt lipectomy "are the essence of the procedure," Dr. Aly said, who noted that about 10% of his patients are male. "The markings are adjustable guidelines, and they vary according to anatomy and desires. It’s a fairly complex set of issues but essentially you have to understand how tissues drape as the patient loses weight, and there are zones of adherence or areas of the body where the skin and the soft tissue envelope is stuck to the underlying musculoskeletal anatomy. It’s important to understand those before you can mark these patients. Surgical improvement is related to the amount of tension that you create above and below an area of excision."

Dr. Aly said that he routinely performs belt lipectomies with another surgeon and strives for surgical times under 6 hours. He uses a general anesthetic and an epidural for postoperative pain management. Moving patients into multiple positions during surgery is required, "otherwise you can’t accomplish the excisions," he said. "There is a variety of different approaches. Mine happens to be one of supine first then lateral/lateral."

Results of body contouring procedures generally correlate with the patient’s body mass index (BMI) at the time of surgery. "So people who present to us above a BMI of 35 kg/m2 ... their results are okay," he said. "Results are better for patients with a BMI of 30-35 kg/m2. If you’re lucky enough to get a patient at an ideal BMI – 26 kg/m2 and lower – then you can create almost normal anatomy."

He noted that, compared with abdominoplasties, results of belt lipectomies take longer than most procedures to mature. "However, their results are also far superior to those attainable with a tummy tuck," Dr. Aly said. Complications, including an increased risk for seroma and formation of hematoma, "correlate with BMI," he said. "If you’re not ready to deal with complications, massive weight loss patients are a tough group to deal with. It’s part of the nature of these patients."

Other areas that often need contouring include upper arm reductions, upper back roll reductions, reconstruction of the breasts (in women and men), and thigh reductions.

Dr. Aly said that he had no relevant conflicts to disclose. SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – Three factors affect the results of body contouring outcomes after bariatric surgery: body mass index at presentation, fat deposition pattern, and quality of the skin-fat envelope, according to Dr. Al S. Aly.

"The fat deposition pattern is genetically controlled; we cannot alter that," Dr. Aly, professor and vice-chair of plastic surgery at the University of California, Irvine, said at the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF). "The quality of the skin-fat envelope is very important. If you have a very loose skin-fat envelope – meaning that they’ve had a tremendous drop in weight – you can do a lot more for them than with other patients."

Dr. Al S. Aly

The two main body contouring treatments for the lower trunk are abdominoplasty and circumferential belt lipectomy, said Dr. Aly. "Abdominoplasties are ideally suited for problems limited to the belly, or those located between the two anterior superior iliac spines. For larger patients you need to do something else."

The rehabilitation of larger patients involves a circumferential procedure commonly referred to as a body lift or belt lipectomy, which involves removing a circumferential wedge of tissue from around the trunk. "There are many reasons why we need circumferential excisions for these large patients, but the main one is that you need circumferential improvement above and below the area of resection as opposed to a regular tummy tuck," he explained.

Markings for the belt lipectomy "are the essence of the procedure," Dr. Aly said, who noted that about 10% of his patients are male. "The markings are adjustable guidelines, and they vary according to anatomy and desires. It’s a fairly complex set of issues but essentially you have to understand how tissues drape as the patient loses weight, and there are zones of adherence or areas of the body where the skin and the soft tissue envelope is stuck to the underlying musculoskeletal anatomy. It’s important to understand those before you can mark these patients. Surgical improvement is related to the amount of tension that you create above and below an area of excision."

Dr. Aly said that he routinely performs belt lipectomies with another surgeon and strives for surgical times under 6 hours. He uses a general anesthetic and an epidural for postoperative pain management. Moving patients into multiple positions during surgery is required, "otherwise you can’t accomplish the excisions," he said. "There is a variety of different approaches. Mine happens to be one of supine first then lateral/lateral."

Results of body contouring procedures generally correlate with the patient’s body mass index (BMI) at the time of surgery. "So people who present to us above a BMI of 35 kg/m2 ... their results are okay," he said. "Results are better for patients with a BMI of 30-35 kg/m2. If you’re lucky enough to get a patient at an ideal BMI – 26 kg/m2 and lower – then you can create almost normal anatomy."

He noted that, compared with abdominoplasties, results of belt lipectomies take longer than most procedures to mature. "However, their results are also far superior to those attainable with a tummy tuck," Dr. Aly said. Complications, including an increased risk for seroma and formation of hematoma, "correlate with BMI," he said. "If you’re not ready to deal with complications, massive weight loss patients are a tough group to deal with. It’s part of the nature of these patients."

Other areas that often need contouring include upper arm reductions, upper back roll reductions, reconstruction of the breasts (in women and men), and thigh reductions.

Dr. Aly said that he had no relevant conflicts to disclose. SDEF and this news organization are owned by Elsevier.

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AT THE SDEF SUMMIT IN AESTHETIC MEDICINE

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ATX-101 Nearing End of Pipeline

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ATX-101 Nearing End of Pipeline

DANA POINT, CALIF. – No longer just a pipe dream, a novel injectable treatment effective at reducing fat is approaching the end of the drug development process.

The product is a non–animal derived, pharmaceutical grade sodium deoxycholate that "acts much like a detergent. It attacks the cell membranes of fat, disrupting and disintegrating its membranes. Thereafter, fat cell contents are released and the subsequent host response, including inflammation, macrophage scavenging, and subclinical fibrosis, may confer a long-lasting fat-removal effect. It doesn’t shrink the fat cell; it ablates the fat it encounters," said, Dr. Adam M. Rotunda.

Dr. Adam M. Rotunda

Phase III trials of an injectable form of sodium deoxycholate for the reduction of submental fat have begun in the United States, building on the previous success of four phase I, three phase II, and two phase III European studies of the product, known as ATX-101, noted Dr. Rotunda at the Summit in Aesthetic Medicine sponsored by the Skin Disease Education Foundation (SDEF).

In the 1990s, compounded phosphatidylcholine/deoxycholate injections (PC/DC), or lipodissolve, caused harm to some patients because "essentially everything about that experience was wrong: the wrong dose (too much volume, too high concentration); wrong depth (injections at times were too superficial. For example, cellulite, which was erroneously believed to improve from the injections, was injected intradermally); wrong indication (injections in places that shouldn’t have been injected); and wrong formulation," said Dr. Rotunda, who practices dermatology in Newport Beach, Calif. "These compounds were [derived] from animal sources and their sterility and purity could be called into question."

As a result, the FDA and other regulatory agencies around the world warned against or banned the use of unapproved PC/DC for aesthetic purposes. But in 2003, sodium deoxycholate was identified as the major component producing fat cell lysis in compounded PC/DC formulations, said Dr. Rotunda, who is also with the department of dermatology at the University of California, Los Angeles. "It’s taken many years to get that message across," he said.

ATX-101, which is being developed by Kythera Biopharmaceuticals, "is very different from the DC in compounded formulations, which was derived from cow bile," he said. "ATX-101 is being studied for very small volumes of fat relatively small for the submental area, which is really an ideal area to observe the desired effect of this product."

Photos courtesy Kythera
A patient is shown before (top images) and 3 months after (bottom images) undergoing four ATX-101 treatments.

Phase I histology studies revealed that ATX-101 causes rapid adipocytolysis on day 1. On day 28 "there’s septal thickening and macrophage infiltration, which removes cellular debris and triglycerides, cleared via the lymphatic system," Dr. Rotunda said, adding that before and after MRIs have quantitatively confirmed the volume reductions.

Tissue surrounding the fatty treatment area, he continued, "has relatively high protein content. This protein (such as albumin) binds and inactivates deoxycholate, making subcutaneous injections relatively safe and fat specific. There’s an inverse relationship: the higher the protein content of certain tissue, such as muscle, tendon, and dermis, the lower the lytic activity of the deoxycholate. Less activity means less damage to that tissue. In fat, however, we want maximal damage, and it works out well because fat has relatively low protein content."

The administration of ATX-101 involves the use of a 30g needle, a 1-mL syringe, and placement of a temporary tattoo grid to the submental fat to control spacing of injections. "The distribution of the grid and how much is injected depends on the patient’s configuration and neck fat volume," Dr. Rotunda said. During the clinical trials, up to 10 mL of medication was used in each session, with up to four monthly treatments.

Most adverse events in clinical trials to date have been mild to moderate. "This is not a lunchtime procedure," he said. "It will be associated with local swelling and tenderness that may last days to several weeks, depending on the amount of ATX-101 injected or the volume of fat treated."

He concluded his remarks by noting that ATX-101 may become a novel approach that complements but does not compete with other fat-reduction therapies.

Dr. Rotunda disclosed that he, along with Dr. Michael S. Kolodney, are coinventors of ATX-101. He is a consultant to Kythera and holds stock in the company. He also is a consultant to Lithera and Allergan.

SDEF and this news organization are owned by Elsevier.

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DANA POINT, CALIF. – No longer just a pipe dream, a novel injectable treatment effective at reducing fat is approaching the end of the drug development process.

The product is a non–animal derived, pharmaceutical grade sodium deoxycholate that "acts much like a detergent. It attacks the cell membranes of fat, disrupting and disintegrating its membranes. Thereafter, fat cell contents are released and the subsequent host response, including inflammation, macrophage scavenging, and subclinical fibrosis, may confer a long-lasting fat-removal effect. It doesn’t shrink the fat cell; it ablates the fat it encounters," said, Dr. Adam M. Rotunda.

Dr. Adam M. Rotunda

Phase III trials of an injectable form of sodium deoxycholate for the reduction of submental fat have begun in the United States, building on the previous success of four phase I, three phase II, and two phase III European studies of the product, known as ATX-101, noted Dr. Rotunda at the Summit in Aesthetic Medicine sponsored by the Skin Disease Education Foundation (SDEF).

In the 1990s, compounded phosphatidylcholine/deoxycholate injections (PC/DC), or lipodissolve, caused harm to some patients because "essentially everything about that experience was wrong: the wrong dose (too much volume, too high concentration); wrong depth (injections at times were too superficial. For example, cellulite, which was erroneously believed to improve from the injections, was injected intradermally); wrong indication (injections in places that shouldn’t have been injected); and wrong formulation," said Dr. Rotunda, who practices dermatology in Newport Beach, Calif. "These compounds were [derived] from animal sources and their sterility and purity could be called into question."

As a result, the FDA and other regulatory agencies around the world warned against or banned the use of unapproved PC/DC for aesthetic purposes. But in 2003, sodium deoxycholate was identified as the major component producing fat cell lysis in compounded PC/DC formulations, said Dr. Rotunda, who is also with the department of dermatology at the University of California, Los Angeles. "It’s taken many years to get that message across," he said.

ATX-101, which is being developed by Kythera Biopharmaceuticals, "is very different from the DC in compounded formulations, which was derived from cow bile," he said. "ATX-101 is being studied for very small volumes of fat relatively small for the submental area, which is really an ideal area to observe the desired effect of this product."

Photos courtesy Kythera
A patient is shown before (top images) and 3 months after (bottom images) undergoing four ATX-101 treatments.

Phase I histology studies revealed that ATX-101 causes rapid adipocytolysis on day 1. On day 28 "there’s septal thickening and macrophage infiltration, which removes cellular debris and triglycerides, cleared via the lymphatic system," Dr. Rotunda said, adding that before and after MRIs have quantitatively confirmed the volume reductions.

Tissue surrounding the fatty treatment area, he continued, "has relatively high protein content. This protein (such as albumin) binds and inactivates deoxycholate, making subcutaneous injections relatively safe and fat specific. There’s an inverse relationship: the higher the protein content of certain tissue, such as muscle, tendon, and dermis, the lower the lytic activity of the deoxycholate. Less activity means less damage to that tissue. In fat, however, we want maximal damage, and it works out well because fat has relatively low protein content."

The administration of ATX-101 involves the use of a 30g needle, a 1-mL syringe, and placement of a temporary tattoo grid to the submental fat to control spacing of injections. "The distribution of the grid and how much is injected depends on the patient’s configuration and neck fat volume," Dr. Rotunda said. During the clinical trials, up to 10 mL of medication was used in each session, with up to four monthly treatments.

Most adverse events in clinical trials to date have been mild to moderate. "This is not a lunchtime procedure," he said. "It will be associated with local swelling and tenderness that may last days to several weeks, depending on the amount of ATX-101 injected or the volume of fat treated."

He concluded his remarks by noting that ATX-101 may become a novel approach that complements but does not compete with other fat-reduction therapies.

Dr. Rotunda disclosed that he, along with Dr. Michael S. Kolodney, are coinventors of ATX-101. He is a consultant to Kythera and holds stock in the company. He also is a consultant to Lithera and Allergan.

SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – No longer just a pipe dream, a novel injectable treatment effective at reducing fat is approaching the end of the drug development process.

The product is a non–animal derived, pharmaceutical grade sodium deoxycholate that "acts much like a detergent. It attacks the cell membranes of fat, disrupting and disintegrating its membranes. Thereafter, fat cell contents are released and the subsequent host response, including inflammation, macrophage scavenging, and subclinical fibrosis, may confer a long-lasting fat-removal effect. It doesn’t shrink the fat cell; it ablates the fat it encounters," said, Dr. Adam M. Rotunda.

Dr. Adam M. Rotunda

Phase III trials of an injectable form of sodium deoxycholate for the reduction of submental fat have begun in the United States, building on the previous success of four phase I, three phase II, and two phase III European studies of the product, known as ATX-101, noted Dr. Rotunda at the Summit in Aesthetic Medicine sponsored by the Skin Disease Education Foundation (SDEF).

In the 1990s, compounded phosphatidylcholine/deoxycholate injections (PC/DC), or lipodissolve, caused harm to some patients because "essentially everything about that experience was wrong: the wrong dose (too much volume, too high concentration); wrong depth (injections at times were too superficial. For example, cellulite, which was erroneously believed to improve from the injections, was injected intradermally); wrong indication (injections in places that shouldn’t have been injected); and wrong formulation," said Dr. Rotunda, who practices dermatology in Newport Beach, Calif. "These compounds were [derived] from animal sources and their sterility and purity could be called into question."

As a result, the FDA and other regulatory agencies around the world warned against or banned the use of unapproved PC/DC for aesthetic purposes. But in 2003, sodium deoxycholate was identified as the major component producing fat cell lysis in compounded PC/DC formulations, said Dr. Rotunda, who is also with the department of dermatology at the University of California, Los Angeles. "It’s taken many years to get that message across," he said.

ATX-101, which is being developed by Kythera Biopharmaceuticals, "is very different from the DC in compounded formulations, which was derived from cow bile," he said. "ATX-101 is being studied for very small volumes of fat relatively small for the submental area, which is really an ideal area to observe the desired effect of this product."

Photos courtesy Kythera
A patient is shown before (top images) and 3 months after (bottom images) undergoing four ATX-101 treatments.

Phase I histology studies revealed that ATX-101 causes rapid adipocytolysis on day 1. On day 28 "there’s septal thickening and macrophage infiltration, which removes cellular debris and triglycerides, cleared via the lymphatic system," Dr. Rotunda said, adding that before and after MRIs have quantitatively confirmed the volume reductions.

Tissue surrounding the fatty treatment area, he continued, "has relatively high protein content. This protein (such as albumin) binds and inactivates deoxycholate, making subcutaneous injections relatively safe and fat specific. There’s an inverse relationship: the higher the protein content of certain tissue, such as muscle, tendon, and dermis, the lower the lytic activity of the deoxycholate. Less activity means less damage to that tissue. In fat, however, we want maximal damage, and it works out well because fat has relatively low protein content."

The administration of ATX-101 involves the use of a 30g needle, a 1-mL syringe, and placement of a temporary tattoo grid to the submental fat to control spacing of injections. "The distribution of the grid and how much is injected depends on the patient’s configuration and neck fat volume," Dr. Rotunda said. During the clinical trials, up to 10 mL of medication was used in each session, with up to four monthly treatments.

Most adverse events in clinical trials to date have been mild to moderate. "This is not a lunchtime procedure," he said. "It will be associated with local swelling and tenderness that may last days to several weeks, depending on the amount of ATX-101 injected or the volume of fat treated."

He concluded his remarks by noting that ATX-101 may become a novel approach that complements but does not compete with other fat-reduction therapies.

Dr. Rotunda disclosed that he, along with Dr. Michael S. Kolodney, are coinventors of ATX-101. He is a consultant to Kythera and holds stock in the company. He also is a consultant to Lithera and Allergan.

SDEF and this news organization are owned by Elsevier.

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EXPERT ANALYSIS FROM THE SDEF SUMMIT IN AESTHETIC MEDICINE

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More Evidence Cryolipolysis Freezes Away Fat

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DANA POINT, CALIF. – A growing body of evidence-based research supports the efficacy of cryolipolysis for noninvasive fat reduction in the abdomen and flanks.

At the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF), Dr. Lawrence S. Bass highlighted results from several recent studies that support its use.

In the first study, presented by Dr. Christine C. Dierickx at the 2012 American Society for Laser Medicine and Surgery (ASLMS) meeting, researchers cataloged side effects in a phone review conducted with patients 1 month following cryolipolysis. All interviewed patients reported erythema that lasted about 1 hour and paresthesia that lasted for up to 1 month after treatment. Other reported side effects were ecchymosis (4%), vasovagal reactions from treatments on the abdomen (2.1%), induration/edema (0.9% and lasting 2-5 weeks), and severe pain (0.6% and lasting for a maximum of 1 month).

A separate study, presented by Dr. Gerald Boey at the 2012 ASLMS meeting, found an amplified fat reduction when concomitant massage was used. For the trial, 10 patients underwent 2 minutes of massage to one side only after cryolipolysis treatment. Ultrasound evaluation revealed that an additional 68% reduction in fat was achieved on the massaged side.

A safety and efficacy trial, carried out at 16 centers and involving 314 patients, was presented by Dr. A. Jay Burns at the 2010 ASLMS meeting. The study found no serious side effects and no skin damage or pigment change from the procedure. Minor side effects included transient bruising, minor pain, reduced sensation, erythema, and edema – all of which resolved spontaneously.

Of 41 patients in the study who underwent ultrasound measurement, the average reduction in fat was 21% after a single procedure. "That’s a consistent number you see in many studies," said Dr. Bass, of the plastic surgery department at New York University School of Medicine.

In a separate study also presented at the 2010 ASLMS meeting, researchers led by Dr. Ivan A. Rosales-Berber investigated the effect of consecutive cryolipolysis treatments separated by 2-3 months. The second treatment resulted in a similar proportion of fat reduction as the first treatment (14.6% vs. 16.5%, respectively).

Three months after the second procedure, the fat layer reduction exceeded 25%. This "means that there is repeatability [with cryolipolysis]," Dr. Bass said. "That’s important, because unfortunately a lot of patients have more than one body contouring emergency in their lives."

An earlier published study determined that cryolipolysis associated with modest reversible short-term changes in peripheral nerve function (Aesthetic Plast. Surg. 2009;33:482-8). Ten patients underwent a thorough neurological evaluation at baseline and weekly after the procedure. All patients returned to baseline peripheral nerve function in an average of 3.6 weeks. The study also found that mean fat reduction by ultrasound was 20.4% at 2 months and 25.5% at 6 months. "Even though we think it takes about 90 days for this whole apoptotic process to resolve, there may be something ongoing, or some tissue consolidation taking place for a longer period of time, allowing patients to continue to improve," Dr. Bass noted.

He concluded his remarks by explaining how he stratifies candidates for liposuction or cryolipolysis. "The patient who wants the maximum improvement or who wants it in one step is definitely going to line up on the liposuction side," he said. "The patient who either needs a small change that’s very localized or prioritizes a quick recovery over the extent of the result is going to line up on the cryolipolysis side."

Dr. Bass disclosed that he is a member of the advisory board for Allergan, Kythera, and Merz Aesthetics. He is also an investigator for Kythera and a consultant to Palomar and Sanuwave.

SDEF and this news organization are owned by Elsevier.

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DANA POINT, CALIF. – A growing body of evidence-based research supports the efficacy of cryolipolysis for noninvasive fat reduction in the abdomen and flanks.

At the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF), Dr. Lawrence S. Bass highlighted results from several recent studies that support its use.

In the first study, presented by Dr. Christine C. Dierickx at the 2012 American Society for Laser Medicine and Surgery (ASLMS) meeting, researchers cataloged side effects in a phone review conducted with patients 1 month following cryolipolysis. All interviewed patients reported erythema that lasted about 1 hour and paresthesia that lasted for up to 1 month after treatment. Other reported side effects were ecchymosis (4%), vasovagal reactions from treatments on the abdomen (2.1%), induration/edema (0.9% and lasting 2-5 weeks), and severe pain (0.6% and lasting for a maximum of 1 month).

A separate study, presented by Dr. Gerald Boey at the 2012 ASLMS meeting, found an amplified fat reduction when concomitant massage was used. For the trial, 10 patients underwent 2 minutes of massage to one side only after cryolipolysis treatment. Ultrasound evaluation revealed that an additional 68% reduction in fat was achieved on the massaged side.

A safety and efficacy trial, carried out at 16 centers and involving 314 patients, was presented by Dr. A. Jay Burns at the 2010 ASLMS meeting. The study found no serious side effects and no skin damage or pigment change from the procedure. Minor side effects included transient bruising, minor pain, reduced sensation, erythema, and edema – all of which resolved spontaneously.

Of 41 patients in the study who underwent ultrasound measurement, the average reduction in fat was 21% after a single procedure. "That’s a consistent number you see in many studies," said Dr. Bass, of the plastic surgery department at New York University School of Medicine.

In a separate study also presented at the 2010 ASLMS meeting, researchers led by Dr. Ivan A. Rosales-Berber investigated the effect of consecutive cryolipolysis treatments separated by 2-3 months. The second treatment resulted in a similar proportion of fat reduction as the first treatment (14.6% vs. 16.5%, respectively).

Three months after the second procedure, the fat layer reduction exceeded 25%. This "means that there is repeatability [with cryolipolysis]," Dr. Bass said. "That’s important, because unfortunately a lot of patients have more than one body contouring emergency in their lives."

An earlier published study determined that cryolipolysis associated with modest reversible short-term changes in peripheral nerve function (Aesthetic Plast. Surg. 2009;33:482-8). Ten patients underwent a thorough neurological evaluation at baseline and weekly after the procedure. All patients returned to baseline peripheral nerve function in an average of 3.6 weeks. The study also found that mean fat reduction by ultrasound was 20.4% at 2 months and 25.5% at 6 months. "Even though we think it takes about 90 days for this whole apoptotic process to resolve, there may be something ongoing, or some tissue consolidation taking place for a longer period of time, allowing patients to continue to improve," Dr. Bass noted.

He concluded his remarks by explaining how he stratifies candidates for liposuction or cryolipolysis. "The patient who wants the maximum improvement or who wants it in one step is definitely going to line up on the liposuction side," he said. "The patient who either needs a small change that’s very localized or prioritizes a quick recovery over the extent of the result is going to line up on the cryolipolysis side."

Dr. Bass disclosed that he is a member of the advisory board for Allergan, Kythera, and Merz Aesthetics. He is also an investigator for Kythera and a consultant to Palomar and Sanuwave.

SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – A growing body of evidence-based research supports the efficacy of cryolipolysis for noninvasive fat reduction in the abdomen and flanks.

At the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF), Dr. Lawrence S. Bass highlighted results from several recent studies that support its use.

In the first study, presented by Dr. Christine C. Dierickx at the 2012 American Society for Laser Medicine and Surgery (ASLMS) meeting, researchers cataloged side effects in a phone review conducted with patients 1 month following cryolipolysis. All interviewed patients reported erythema that lasted about 1 hour and paresthesia that lasted for up to 1 month after treatment. Other reported side effects were ecchymosis (4%), vasovagal reactions from treatments on the abdomen (2.1%), induration/edema (0.9% and lasting 2-5 weeks), and severe pain (0.6% and lasting for a maximum of 1 month).

A separate study, presented by Dr. Gerald Boey at the 2012 ASLMS meeting, found an amplified fat reduction when concomitant massage was used. For the trial, 10 patients underwent 2 minutes of massage to one side only after cryolipolysis treatment. Ultrasound evaluation revealed that an additional 68% reduction in fat was achieved on the massaged side.

A safety and efficacy trial, carried out at 16 centers and involving 314 patients, was presented by Dr. A. Jay Burns at the 2010 ASLMS meeting. The study found no serious side effects and no skin damage or pigment change from the procedure. Minor side effects included transient bruising, minor pain, reduced sensation, erythema, and edema – all of which resolved spontaneously.

Of 41 patients in the study who underwent ultrasound measurement, the average reduction in fat was 21% after a single procedure. "That’s a consistent number you see in many studies," said Dr. Bass, of the plastic surgery department at New York University School of Medicine.

In a separate study also presented at the 2010 ASLMS meeting, researchers led by Dr. Ivan A. Rosales-Berber investigated the effect of consecutive cryolipolysis treatments separated by 2-3 months. The second treatment resulted in a similar proportion of fat reduction as the first treatment (14.6% vs. 16.5%, respectively).

Three months after the second procedure, the fat layer reduction exceeded 25%. This "means that there is repeatability [with cryolipolysis]," Dr. Bass said. "That’s important, because unfortunately a lot of patients have more than one body contouring emergency in their lives."

An earlier published study determined that cryolipolysis associated with modest reversible short-term changes in peripheral nerve function (Aesthetic Plast. Surg. 2009;33:482-8). Ten patients underwent a thorough neurological evaluation at baseline and weekly after the procedure. All patients returned to baseline peripheral nerve function in an average of 3.6 weeks. The study also found that mean fat reduction by ultrasound was 20.4% at 2 months and 25.5% at 6 months. "Even though we think it takes about 90 days for this whole apoptotic process to resolve, there may be something ongoing, or some tissue consolidation taking place for a longer period of time, allowing patients to continue to improve," Dr. Bass noted.

He concluded his remarks by explaining how he stratifies candidates for liposuction or cryolipolysis. "The patient who wants the maximum improvement or who wants it in one step is definitely going to line up on the liposuction side," he said. "The patient who either needs a small change that’s very localized or prioritizes a quick recovery over the extent of the result is going to line up on the cryolipolysis side."

Dr. Bass disclosed that he is a member of the advisory board for Allergan, Kythera, and Merz Aesthetics. He is also an investigator for Kythera and a consultant to Palomar and Sanuwave.

SDEF and this news organization are owned by Elsevier.

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Experimental Traser Device Could Be Laser's Replacement

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Experimental Traser Device Could Be Laser's Replacement

DANA POINT, CALIF. – A new therapeutic light source being developed in Israel may ultimately replace many of the aesthetic laser devices currently used.

The device, known as Traser (Total Reflection Amplification of Spontaneous Emission of Radiation), "is not a laser and it’s not an intense pulsed light," Dr. Christopher Zachary said at the SDEF Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF).

"No photons come from the flash lamps. It’s one device with many wavelengths. It’s tunable, has a high peak power, and has variable pulse duration from 0.45 to 100 milliseconds," he said.

The Traser contains a "dye cell" (an internally reflecting body that hosts a fluorescent dye), one rear mirror, flashlamps above and below, an output waveguide, and a reflector cavity that houses the device. The Traser is the brainchild of Morgan Gustavsson, a pioneer of intense pulsed-light technology. It was first described in the peer-reviewed online journal PLoS ONE (2012;7:e35899 [doi: 10.1371/journal.pone.0035899]).

"It’s one device with many wavelengths. It’s tunable, has a high peak power, and has variable pulse duration from 0.45 to 100 milliseconds," Dr. Christopher Zachary said.

Unlike a laser, the Traser has no optical resonator, no output coupler, no stimulated emission, no filters, and no filter technology. "Photons from the flash lamps excite fluorescent dye material and spontaneously emit a different narrow spectrum of light," explained Dr. Zachary, professor and chair of the dermatology department at the University of California, Irvine, who plans to begin studying the device this summer.

"This traps 45%-61% of the light that’s generated, and the photons propagate axially along the length of the dye cell in both directions. The mirror redirects the light forward, and light is passively coupled out at the distal end of the cell," he said.

The dyes used to date are water soluble, "and do not require hazardous solvents or additives," wrote Dr. Zachary and Mr. Gustavsson, who is with Rockport Consulting Services in Newport Beach, Calif., in the PLoS One article. "When required, [the dyes] are reclaimed by a filter loop, which in less than a minute can completely eliminate the dye and purify the circulating water. This water is not only reconstituted with new dyes within the Traser circulation cavity, but is also used to cool the device."

Changing the dye enables the user to produce UVA, blue, green, orange, red, and near-infrared wavelengths, which allows for wide variability in a single device. The fluorescent dyes used and described in the PLoS ONE article include pyrromethene 556, rhodamine 590, and sulforhodamine 640 chloride. "The wavelength that comes out is dependent on the dye that you use and its concentration," Dr. Zachary said at the meeting. "It’s a very manipulable yet sensitive system."

In theory, the Traser "could replace the KTP laser and could be very good for individual blood vessels, for instance, or a rosaceous blush. It could replace the ruby laser as a hair-removal device, or the pulsed dye laser for port wine stains – all from a single device. All you do is change the dye. I love the science of this: It’s simple but has all the characteristics of a device that is going to be very effective. I’d like to see some studies conducted in animals and in humans."

He concluded his remarks by predicting that the TRASER will probably be less costly than a laser, and "highly tunable and with multiple pulse durations, and one that could replace three to five lasers in your office."

Dr. Zachary said that he had no relevant financial conflicts to disclose. SDEF and this news organization are owned by Elsevier.

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DANA POINT, CALIF. – A new therapeutic light source being developed in Israel may ultimately replace many of the aesthetic laser devices currently used.

The device, known as Traser (Total Reflection Amplification of Spontaneous Emission of Radiation), "is not a laser and it’s not an intense pulsed light," Dr. Christopher Zachary said at the SDEF Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF).

"No photons come from the flash lamps. It’s one device with many wavelengths. It’s tunable, has a high peak power, and has variable pulse duration from 0.45 to 100 milliseconds," he said.

The Traser contains a "dye cell" (an internally reflecting body that hosts a fluorescent dye), one rear mirror, flashlamps above and below, an output waveguide, and a reflector cavity that houses the device. The Traser is the brainchild of Morgan Gustavsson, a pioneer of intense pulsed-light technology. It was first described in the peer-reviewed online journal PLoS ONE (2012;7:e35899 [doi: 10.1371/journal.pone.0035899]).

"It’s one device with many wavelengths. It’s tunable, has a high peak power, and has variable pulse duration from 0.45 to 100 milliseconds," Dr. Christopher Zachary said.

Unlike a laser, the Traser has no optical resonator, no output coupler, no stimulated emission, no filters, and no filter technology. "Photons from the flash lamps excite fluorescent dye material and spontaneously emit a different narrow spectrum of light," explained Dr. Zachary, professor and chair of the dermatology department at the University of California, Irvine, who plans to begin studying the device this summer.

"This traps 45%-61% of the light that’s generated, and the photons propagate axially along the length of the dye cell in both directions. The mirror redirects the light forward, and light is passively coupled out at the distal end of the cell," he said.

The dyes used to date are water soluble, "and do not require hazardous solvents or additives," wrote Dr. Zachary and Mr. Gustavsson, who is with Rockport Consulting Services in Newport Beach, Calif., in the PLoS One article. "When required, [the dyes] are reclaimed by a filter loop, which in less than a minute can completely eliminate the dye and purify the circulating water. This water is not only reconstituted with new dyes within the Traser circulation cavity, but is also used to cool the device."

Changing the dye enables the user to produce UVA, blue, green, orange, red, and near-infrared wavelengths, which allows for wide variability in a single device. The fluorescent dyes used and described in the PLoS ONE article include pyrromethene 556, rhodamine 590, and sulforhodamine 640 chloride. "The wavelength that comes out is dependent on the dye that you use and its concentration," Dr. Zachary said at the meeting. "It’s a very manipulable yet sensitive system."

In theory, the Traser "could replace the KTP laser and could be very good for individual blood vessels, for instance, or a rosaceous blush. It could replace the ruby laser as a hair-removal device, or the pulsed dye laser for port wine stains – all from a single device. All you do is change the dye. I love the science of this: It’s simple but has all the characteristics of a device that is going to be very effective. I’d like to see some studies conducted in animals and in humans."

He concluded his remarks by predicting that the TRASER will probably be less costly than a laser, and "highly tunable and with multiple pulse durations, and one that could replace three to five lasers in your office."

Dr. Zachary said that he had no relevant financial conflicts to disclose. SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – A new therapeutic light source being developed in Israel may ultimately replace many of the aesthetic laser devices currently used.

The device, known as Traser (Total Reflection Amplification of Spontaneous Emission of Radiation), "is not a laser and it’s not an intense pulsed light," Dr. Christopher Zachary said at the SDEF Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF).

"No photons come from the flash lamps. It’s one device with many wavelengths. It’s tunable, has a high peak power, and has variable pulse duration from 0.45 to 100 milliseconds," he said.

The Traser contains a "dye cell" (an internally reflecting body that hosts a fluorescent dye), one rear mirror, flashlamps above and below, an output waveguide, and a reflector cavity that houses the device. The Traser is the brainchild of Morgan Gustavsson, a pioneer of intense pulsed-light technology. It was first described in the peer-reviewed online journal PLoS ONE (2012;7:e35899 [doi: 10.1371/journal.pone.0035899]).

"It’s one device with many wavelengths. It’s tunable, has a high peak power, and has variable pulse duration from 0.45 to 100 milliseconds," Dr. Christopher Zachary said.

Unlike a laser, the Traser has no optical resonator, no output coupler, no stimulated emission, no filters, and no filter technology. "Photons from the flash lamps excite fluorescent dye material and spontaneously emit a different narrow spectrum of light," explained Dr. Zachary, professor and chair of the dermatology department at the University of California, Irvine, who plans to begin studying the device this summer.

"This traps 45%-61% of the light that’s generated, and the photons propagate axially along the length of the dye cell in both directions. The mirror redirects the light forward, and light is passively coupled out at the distal end of the cell," he said.

The dyes used to date are water soluble, "and do not require hazardous solvents or additives," wrote Dr. Zachary and Mr. Gustavsson, who is with Rockport Consulting Services in Newport Beach, Calif., in the PLoS One article. "When required, [the dyes] are reclaimed by a filter loop, which in less than a minute can completely eliminate the dye and purify the circulating water. This water is not only reconstituted with new dyes within the Traser circulation cavity, but is also used to cool the device."

Changing the dye enables the user to produce UVA, blue, green, orange, red, and near-infrared wavelengths, which allows for wide variability in a single device. The fluorescent dyes used and described in the PLoS ONE article include pyrromethene 556, rhodamine 590, and sulforhodamine 640 chloride. "The wavelength that comes out is dependent on the dye that you use and its concentration," Dr. Zachary said at the meeting. "It’s a very manipulable yet sensitive system."

In theory, the Traser "could replace the KTP laser and could be very good for individual blood vessels, for instance, or a rosaceous blush. It could replace the ruby laser as a hair-removal device, or the pulsed dye laser for port wine stains – all from a single device. All you do is change the dye. I love the science of this: It’s simple but has all the characteristics of a device that is going to be very effective. I’d like to see some studies conducted in animals and in humans."

He concluded his remarks by predicting that the TRASER will probably be less costly than a laser, and "highly tunable and with multiple pulse durations, and one that could replace three to five lasers in your office."

Dr. Zachary said that he had no relevant financial conflicts to disclose. SDEF and this news organization are owned by Elsevier.

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Liposonix Slimmed Waists by Almost 3 cm

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Liposonix Slimmed Waists by Almost 3 cm

DANA POINT, CALIF. – Of the 152 patients who have been treated with the Liposonix body sculpting system in controlled clinical trials to date, the average reduction in waist circumference reached 2.8 cm.

The system, cleared by the Food and Drug Administration in September 2011 for noninvasive fat removal, "has a good safety profile, no discernible effect on internal organs or adjacent structures, and minimal adverse events," Dr. Michael A.C. Kane said at the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF), where he reviewed the evidence on the device.

Solta Medical's Liposonix system uses high-intensity, focused ultrasound to destroy anterior abdominal subcutaneous adipose tissue in a single treatment without harming skin or surrounding tissue. The pattern generator of the device "allows for uniform delivery of ultrasonic energy, analogous to pattern generators used with aesthetic lasers," said Dr. Kane, a plastic surgeon in private practice in New York. The treatment area measures 21 cm2.

Liposonix's mechanism of action is necrosis by a thermal process. "An ultrasound beam that can focus at a specific depth beneath the dermis, combined with proprietary application techniques, results in the intended adipose tissue disruption," Dr. Kane explained. "The pattern generator moves the focus of the ultrasound to successive parts of the adipose tissue. The automated movement of the transducer creates a matrix of lesions produced by highly focused, high-intensity ultrasound."

Macrophage cells, he continued, "are attracted to the treated area to engulf and transport lipids and cellular debris. As the treated area is cleared, the lesion resolves naturally and results in an overall reduction in local adipose tissue volume."

According to data on the 152 patients treated with Liposonix, the most common post-treatment side effects were temporary erythema, mild ecchymosis, discomfort, and edema. The total energy dose ranged from 118 to 148 J/cm2, the treatment depth was 13 mm beneath the skin line, and the average change in waist circumference was a reduction of 2.8 cm, generally within 8-12 weeks post treatment. No significant changes in blood lipid levels, liver function tests, or other blood parameters were observed.

Patients expressed a high degree of satisfaction, Dr. Kane said, with 91.3% saying they were satisfied with the results of treatment and 87% saying they were likely or very likely to have a second treatment.

The bottom line, he concluded, "is that ... ultrasonic energy can be accurately used to kill fat cells."

Dr. Kane disclosed that he received compensation from Medicis, which originally developed the Liposonix system, as a consultant and research investigator.

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DANA POINT, CALIF. – Of the 152 patients who have been treated with the Liposonix body sculpting system in controlled clinical trials to date, the average reduction in waist circumference reached 2.8 cm.

The system, cleared by the Food and Drug Administration in September 2011 for noninvasive fat removal, "has a good safety profile, no discernible effect on internal organs or adjacent structures, and minimal adverse events," Dr. Michael A.C. Kane said at the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF), where he reviewed the evidence on the device.

Solta Medical's Liposonix system uses high-intensity, focused ultrasound to destroy anterior abdominal subcutaneous adipose tissue in a single treatment without harming skin or surrounding tissue. The pattern generator of the device "allows for uniform delivery of ultrasonic energy, analogous to pattern generators used with aesthetic lasers," said Dr. Kane, a plastic surgeon in private practice in New York. The treatment area measures 21 cm2.

Liposonix's mechanism of action is necrosis by a thermal process. "An ultrasound beam that can focus at a specific depth beneath the dermis, combined with proprietary application techniques, results in the intended adipose tissue disruption," Dr. Kane explained. "The pattern generator moves the focus of the ultrasound to successive parts of the adipose tissue. The automated movement of the transducer creates a matrix of lesions produced by highly focused, high-intensity ultrasound."

Macrophage cells, he continued, "are attracted to the treated area to engulf and transport lipids and cellular debris. As the treated area is cleared, the lesion resolves naturally and results in an overall reduction in local adipose tissue volume."

According to data on the 152 patients treated with Liposonix, the most common post-treatment side effects were temporary erythema, mild ecchymosis, discomfort, and edema. The total energy dose ranged from 118 to 148 J/cm2, the treatment depth was 13 mm beneath the skin line, and the average change in waist circumference was a reduction of 2.8 cm, generally within 8-12 weeks post treatment. No significant changes in blood lipid levels, liver function tests, or other blood parameters were observed.

Patients expressed a high degree of satisfaction, Dr. Kane said, with 91.3% saying they were satisfied with the results of treatment and 87% saying they were likely or very likely to have a second treatment.

The bottom line, he concluded, "is that ... ultrasonic energy can be accurately used to kill fat cells."

Dr. Kane disclosed that he received compensation from Medicis, which originally developed the Liposonix system, as a consultant and research investigator.

SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – Of the 152 patients who have been treated with the Liposonix body sculpting system in controlled clinical trials to date, the average reduction in waist circumference reached 2.8 cm.

The system, cleared by the Food and Drug Administration in September 2011 for noninvasive fat removal, "has a good safety profile, no discernible effect on internal organs or adjacent structures, and minimal adverse events," Dr. Michael A.C. Kane said at the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF), where he reviewed the evidence on the device.

Solta Medical's Liposonix system uses high-intensity, focused ultrasound to destroy anterior abdominal subcutaneous adipose tissue in a single treatment without harming skin or surrounding tissue. The pattern generator of the device "allows for uniform delivery of ultrasonic energy, analogous to pattern generators used with aesthetic lasers," said Dr. Kane, a plastic surgeon in private practice in New York. The treatment area measures 21 cm2.

Liposonix's mechanism of action is necrosis by a thermal process. "An ultrasound beam that can focus at a specific depth beneath the dermis, combined with proprietary application techniques, results in the intended adipose tissue disruption," Dr. Kane explained. "The pattern generator moves the focus of the ultrasound to successive parts of the adipose tissue. The automated movement of the transducer creates a matrix of lesions produced by highly focused, high-intensity ultrasound."

Macrophage cells, he continued, "are attracted to the treated area to engulf and transport lipids and cellular debris. As the treated area is cleared, the lesion resolves naturally and results in an overall reduction in local adipose tissue volume."

According to data on the 152 patients treated with Liposonix, the most common post-treatment side effects were temporary erythema, mild ecchymosis, discomfort, and edema. The total energy dose ranged from 118 to 148 J/cm2, the treatment depth was 13 mm beneath the skin line, and the average change in waist circumference was a reduction of 2.8 cm, generally within 8-12 weeks post treatment. No significant changes in blood lipid levels, liver function tests, or other blood parameters were observed.

Patients expressed a high degree of satisfaction, Dr. Kane said, with 91.3% saying they were satisfied with the results of treatment and 87% saying they were likely or very likely to have a second treatment.

The bottom line, he concluded, "is that ... ultrasonic energy can be accurately used to kill fat cells."

Dr. Kane disclosed that he received compensation from Medicis, which originally developed the Liposonix system, as a consultant and research investigator.

SDEF and this news organization are owned by Elsevier.

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Frozen Fat Returns Volume to Aging Face

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Frozen Fat Returns Volume to Aging Face

DANA POINT, CALIF. – Fat transfer for facial volume restoration holds certain advantages over off-the-shelf fillers, according to Dr. Lisa M. Donofrio. Chief among them is that the procedure involves adding a biologically identical substance to the targeted treatment area.

Fat transfer "is also capable of dramatic changes [and] has the potential for permanence; it's nonreactive, and it may promote stem cell growth," Dr. Donofrio said at the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF).

Dr. Lisa M. Donofrio

In the upper third of the face, the goal of fat transfer is to achieve a smooth, convex forehead, forehead to brow continuity, full temples, and a "railroad tracking" of the upper lid, "so that the upper lid margin and the sulcus are parallel," said Dr. Donofrio of the department of dermatology at Yale University, New Haven, Conn. Advantages of using fat in the upper face, she said, "are that the results can be dramatic; it’s opaque; it’s structural and can be put in all layers of the skin; and it’s very long lasting."

In the middle third of the face, the goal of fat transfer is to achieve a smooth, convex cheek, lid to cheek continuity, full buccal fat, and a broad cheekbone, said Dr. Donofrio, who is also with the department of dermatology at Tulane University in New Orleans. She characterized fat transfer in the middle third of the face as "the longest lasting and [most economical] large-volume filler. It’s able to achieve three-dimensional volumization and it has very predictable longevity."

In the lower third of the face, the goal of fat transfer is to achieve cheek to prementum continuity, bucca to chin continuity, a continuous jawline sweep, and a full submandibular area. "The strength of fat in this area is its ability to be structural," she explained. "When combined with microsuction, it can redistribute fat to a youthful contour."

Dr. Donofrio routinely freezes fat prior to transfer "because it works," she said. "Why does it work? I have no idea, but maybe there is some microenvironment that is creating growth factors."

She uses the centrifuge minimally, "just to remove some of the tumescent fluid," and leaves triglycerides in the syringe. She places the fat into a freezer at –20° C for up to 12 hours, and then moves it to a plasma freezer at –30° C. She defrosts the fat rapidly prior to transfer.

Of the more than 6,000 fat transfers she has performed, about three-quarters of them have involved frozen fat. When patients return to her for additional volumization, "they will not entertain the idea of doing only a fresh fat transfer, because they think the frozen fat transfer did so well," she noted.

Dr. Donofrio disclosed that she is a member of the scientific advisory board of, a consultant to, and investigator for Allergan and Medicis. She is also an investigator for Cynosure, Kythera, Mentor, and Merz.

SDEF and this news organization are owned by Elsevier.

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DANA POINT, CALIF. – Fat transfer for facial volume restoration holds certain advantages over off-the-shelf fillers, according to Dr. Lisa M. Donofrio. Chief among them is that the procedure involves adding a biologically identical substance to the targeted treatment area.

Fat transfer "is also capable of dramatic changes [and] has the potential for permanence; it's nonreactive, and it may promote stem cell growth," Dr. Donofrio said at the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF).

Dr. Lisa M. Donofrio

In the upper third of the face, the goal of fat transfer is to achieve a smooth, convex forehead, forehead to brow continuity, full temples, and a "railroad tracking" of the upper lid, "so that the upper lid margin and the sulcus are parallel," said Dr. Donofrio of the department of dermatology at Yale University, New Haven, Conn. Advantages of using fat in the upper face, she said, "are that the results can be dramatic; it’s opaque; it’s structural and can be put in all layers of the skin; and it’s very long lasting."

In the middle third of the face, the goal of fat transfer is to achieve a smooth, convex cheek, lid to cheek continuity, full buccal fat, and a broad cheekbone, said Dr. Donofrio, who is also with the department of dermatology at Tulane University in New Orleans. She characterized fat transfer in the middle third of the face as "the longest lasting and [most economical] large-volume filler. It’s able to achieve three-dimensional volumization and it has very predictable longevity."

In the lower third of the face, the goal of fat transfer is to achieve cheek to prementum continuity, bucca to chin continuity, a continuous jawline sweep, and a full submandibular area. "The strength of fat in this area is its ability to be structural," she explained. "When combined with microsuction, it can redistribute fat to a youthful contour."

Dr. Donofrio routinely freezes fat prior to transfer "because it works," she said. "Why does it work? I have no idea, but maybe there is some microenvironment that is creating growth factors."

She uses the centrifuge minimally, "just to remove some of the tumescent fluid," and leaves triglycerides in the syringe. She places the fat into a freezer at –20° C for up to 12 hours, and then moves it to a plasma freezer at –30° C. She defrosts the fat rapidly prior to transfer.

Of the more than 6,000 fat transfers she has performed, about three-quarters of them have involved frozen fat. When patients return to her for additional volumization, "they will not entertain the idea of doing only a fresh fat transfer, because they think the frozen fat transfer did so well," she noted.

Dr. Donofrio disclosed that she is a member of the scientific advisory board of, a consultant to, and investigator for Allergan and Medicis. She is also an investigator for Cynosure, Kythera, Mentor, and Merz.

SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – Fat transfer for facial volume restoration holds certain advantages over off-the-shelf fillers, according to Dr. Lisa M. Donofrio. Chief among them is that the procedure involves adding a biologically identical substance to the targeted treatment area.

Fat transfer "is also capable of dramatic changes [and] has the potential for permanence; it's nonreactive, and it may promote stem cell growth," Dr. Donofrio said at the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF).

Dr. Lisa M. Donofrio

In the upper third of the face, the goal of fat transfer is to achieve a smooth, convex forehead, forehead to brow continuity, full temples, and a "railroad tracking" of the upper lid, "so that the upper lid margin and the sulcus are parallel," said Dr. Donofrio of the department of dermatology at Yale University, New Haven, Conn. Advantages of using fat in the upper face, she said, "are that the results can be dramatic; it’s opaque; it’s structural and can be put in all layers of the skin; and it’s very long lasting."

In the middle third of the face, the goal of fat transfer is to achieve a smooth, convex cheek, lid to cheek continuity, full buccal fat, and a broad cheekbone, said Dr. Donofrio, who is also with the department of dermatology at Tulane University in New Orleans. She characterized fat transfer in the middle third of the face as "the longest lasting and [most economical] large-volume filler. It’s able to achieve three-dimensional volumization and it has very predictable longevity."

In the lower third of the face, the goal of fat transfer is to achieve cheek to prementum continuity, bucca to chin continuity, a continuous jawline sweep, and a full submandibular area. "The strength of fat in this area is its ability to be structural," she explained. "When combined with microsuction, it can redistribute fat to a youthful contour."

Dr. Donofrio routinely freezes fat prior to transfer "because it works," she said. "Why does it work? I have no idea, but maybe there is some microenvironment that is creating growth factors."

She uses the centrifuge minimally, "just to remove some of the tumescent fluid," and leaves triglycerides in the syringe. She places the fat into a freezer at –20° C for up to 12 hours, and then moves it to a plasma freezer at –30° C. She defrosts the fat rapidly prior to transfer.

Of the more than 6,000 fat transfers she has performed, about three-quarters of them have involved frozen fat. When patients return to her for additional volumization, "they will not entertain the idea of doing only a fresh fat transfer, because they think the frozen fat transfer did so well," she noted.

Dr. Donofrio disclosed that she is a member of the scientific advisory board of, a consultant to, and investigator for Allergan and Medicis. She is also an investigator for Cynosure, Kythera, Mentor, and Merz.

SDEF and this news organization are owned by Elsevier.

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At-Home Hair Removal Device No Better Than Shaving

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At-Home Hair Removal Device No Better Than Shaving

DANA POINT, CALIF. – An at-home, consumer hot-wire hair removal device worked no better than did standard shaving, according to a recent study.

"Relative to shaving, treatment with the hot-wire device did not produce statistically significant differences in the percentage change from baseline in hair count, duration of hair removal effect, or color and/or thickness of regrowing hair," Dr. Brian S. Biesman said.

© Casarsa/iStockphoto.com
Active hair follicles and hair regrowth were not affected by a series of treatments with the hair removal device.

There have been no controlled published studies of the no!no! hair removal device (manufactured by Radiancy) in peer-reviewed literature, which led Dr. Biesman to conduct a small study comparing the device’s efficacy with that of standard shaving.

According to information on the no!no! website, the device uses Thermicon technology "to conduct a gentle pulse of heat to the hair," which "instantly removes hair and slows the rate of hair regrowth with no pain." In Dr. Biesman’s study, however, the effectiveness of the hot-wire device, used according to the manufacturer’s recommendations (four passes per session), was found to be equivalent to standard shaving for all study end points.

For instance, active hair follicles and hair regrowth were not affected by a series of treatments with the hair removal device, compared with shaving. Also, hair thickness and color did not change after treatment with the device, Dr. Biesman reported in a poster at the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF).

A total of 23 patients (7 men, 16 women) aged 18-55 years completed the study; 90% of participants were white. Two sites on one leg of each patient were shaved 4 days before baseline, and then were treated every 3-4 days with the hot-wire device on one site on the leg and by shaving the other site for 8 weeks. The treatment sites were two symmetric 3 × 3 cm areas of the leg that were 3 cm apart and contained at least 15 hairs. The corners of the sites were micro-tattooed with ink, which was visible under black light.

Photographs were taken to measure hair count at baseline, weekly during treatment (before and after), at 4 days following final treatment, and at each follow-up visit (4, 8, and 12 weeks after final treatment), and "blinded visual and digital assessments were made for hair thickness and color," noted Dr. Biesman, who has a private practice in Nashville, Tenn.

The mean baseline hair count of the hot-wire and shaving sites were 86 and 79, respectively, "which remained stable during the 8-week treatment phase. No hair count reduction was seen." At post-treatment follow up, hair counts increased to 95 (treatment site) and 84 (shaving site) at 4 days, 104 and 99 at 1 month, 106 and 100 at 2 months, and 109 and 105 at 3 months. Hair regrowth was noted immediately after ceasing treatment with the hot-wire device.

The mean percent change at 4 days post treatment was 19% with the hot-wire device, compared with 14% with shaving; 41% and 41% at 1 month post treatment; 31% and 28% at 2 months post treatment; and 32% and 37% at 3 months.

A study limitation was that hair removal was evaluated only on the lower leg to sites not randomly assigned.

The study was sponsored by Tria Beauty, for which Dr. Biesman has consulted and from which he has received research support. SDEF and this news organization are owned by Elsevier.

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DANA POINT, CALIF. – An at-home, consumer hot-wire hair removal device worked no better than did standard shaving, according to a recent study.

"Relative to shaving, treatment with the hot-wire device did not produce statistically significant differences in the percentage change from baseline in hair count, duration of hair removal effect, or color and/or thickness of regrowing hair," Dr. Brian S. Biesman said.

© Casarsa/iStockphoto.com
Active hair follicles and hair regrowth were not affected by a series of treatments with the hair removal device.

There have been no controlled published studies of the no!no! hair removal device (manufactured by Radiancy) in peer-reviewed literature, which led Dr. Biesman to conduct a small study comparing the device’s efficacy with that of standard shaving.

According to information on the no!no! website, the device uses Thermicon technology "to conduct a gentle pulse of heat to the hair," which "instantly removes hair and slows the rate of hair regrowth with no pain." In Dr. Biesman’s study, however, the effectiveness of the hot-wire device, used according to the manufacturer’s recommendations (four passes per session), was found to be equivalent to standard shaving for all study end points.

For instance, active hair follicles and hair regrowth were not affected by a series of treatments with the hair removal device, compared with shaving. Also, hair thickness and color did not change after treatment with the device, Dr. Biesman reported in a poster at the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF).

A total of 23 patients (7 men, 16 women) aged 18-55 years completed the study; 90% of participants were white. Two sites on one leg of each patient were shaved 4 days before baseline, and then were treated every 3-4 days with the hot-wire device on one site on the leg and by shaving the other site for 8 weeks. The treatment sites were two symmetric 3 × 3 cm areas of the leg that were 3 cm apart and contained at least 15 hairs. The corners of the sites were micro-tattooed with ink, which was visible under black light.

Photographs were taken to measure hair count at baseline, weekly during treatment (before and after), at 4 days following final treatment, and at each follow-up visit (4, 8, and 12 weeks after final treatment), and "blinded visual and digital assessments were made for hair thickness and color," noted Dr. Biesman, who has a private practice in Nashville, Tenn.

The mean baseline hair count of the hot-wire and shaving sites were 86 and 79, respectively, "which remained stable during the 8-week treatment phase. No hair count reduction was seen." At post-treatment follow up, hair counts increased to 95 (treatment site) and 84 (shaving site) at 4 days, 104 and 99 at 1 month, 106 and 100 at 2 months, and 109 and 105 at 3 months. Hair regrowth was noted immediately after ceasing treatment with the hot-wire device.

The mean percent change at 4 days post treatment was 19% with the hot-wire device, compared with 14% with shaving; 41% and 41% at 1 month post treatment; 31% and 28% at 2 months post treatment; and 32% and 37% at 3 months.

A study limitation was that hair removal was evaluated only on the lower leg to sites not randomly assigned.

The study was sponsored by Tria Beauty, for which Dr. Biesman has consulted and from which he has received research support. SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – An at-home, consumer hot-wire hair removal device worked no better than did standard shaving, according to a recent study.

"Relative to shaving, treatment with the hot-wire device did not produce statistically significant differences in the percentage change from baseline in hair count, duration of hair removal effect, or color and/or thickness of regrowing hair," Dr. Brian S. Biesman said.

© Casarsa/iStockphoto.com
Active hair follicles and hair regrowth were not affected by a series of treatments with the hair removal device.

There have been no controlled published studies of the no!no! hair removal device (manufactured by Radiancy) in peer-reviewed literature, which led Dr. Biesman to conduct a small study comparing the device’s efficacy with that of standard shaving.

According to information on the no!no! website, the device uses Thermicon technology "to conduct a gentle pulse of heat to the hair," which "instantly removes hair and slows the rate of hair regrowth with no pain." In Dr. Biesman’s study, however, the effectiveness of the hot-wire device, used according to the manufacturer’s recommendations (four passes per session), was found to be equivalent to standard shaving for all study end points.

For instance, active hair follicles and hair regrowth were not affected by a series of treatments with the hair removal device, compared with shaving. Also, hair thickness and color did not change after treatment with the device, Dr. Biesman reported in a poster at the Summit in Aesthetic Medicine sponsored by Skin Disease Education Foundation (SDEF).

A total of 23 patients (7 men, 16 women) aged 18-55 years completed the study; 90% of participants were white. Two sites on one leg of each patient were shaved 4 days before baseline, and then were treated every 3-4 days with the hot-wire device on one site on the leg and by shaving the other site for 8 weeks. The treatment sites were two symmetric 3 × 3 cm areas of the leg that were 3 cm apart and contained at least 15 hairs. The corners of the sites were micro-tattooed with ink, which was visible under black light.

Photographs were taken to measure hair count at baseline, weekly during treatment (before and after), at 4 days following final treatment, and at each follow-up visit (4, 8, and 12 weeks after final treatment), and "blinded visual and digital assessments were made for hair thickness and color," noted Dr. Biesman, who has a private practice in Nashville, Tenn.

The mean baseline hair count of the hot-wire and shaving sites were 86 and 79, respectively, "which remained stable during the 8-week treatment phase. No hair count reduction was seen." At post-treatment follow up, hair counts increased to 95 (treatment site) and 84 (shaving site) at 4 days, 104 and 99 at 1 month, 106 and 100 at 2 months, and 109 and 105 at 3 months. Hair regrowth was noted immediately after ceasing treatment with the hot-wire device.

The mean percent change at 4 days post treatment was 19% with the hot-wire device, compared with 14% with shaving; 41% and 41% at 1 month post treatment; 31% and 28% at 2 months post treatment; and 32% and 37% at 3 months.

A study limitation was that hair removal was evaluated only on the lower leg to sites not randomly assigned.

The study was sponsored by Tria Beauty, for which Dr. Biesman has consulted and from which he has received research support. SDEF and this news organization are owned by Elsevier.

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Major Finding: The mean percent change at 4 days post treatment was 19% with the hot-wire device, compared with 14% with shaving; 41% and 41% after 1 month; 31% and 28% after 2 months; and 32% and 37% after 3 months.

Data Source: Twenty-three patients (7 men, 16 women) aged 18-55 years completed the study; 90% of participants were white.

Disclosures: The study was sponsored by Tria Beauty, for which Dr. Biesman has consulted and from which he has received research support. SDEF and this news organization are owned by Elsevier.