ASAPS:Investigational New Drug Application for “Fat Melting” Injections Cleared by the FDA
Clinical trial on injection lipolysis treatment to begin soon
Comment by the NETWORK
The following press release was published by ASAPS:
New York, NY (September 4, 2007) – The Aesthetic Surgery Education and Research Foundation (ASERF) announced today that it has received approval from the U.S. Food and Drug Administration to initiate a clinical trial investigating the safety and efficacy of one type of injection lipolysis treatment.
Treatments most properly called injection lipolysis have been commonly associated with the terms mesotherapy or fat dissolving “Lipodissolve”. These types of treatments claim to reduce or eliminate unwanted local accumulations of fat, but their ingredients and injection locations and techniques may vary slightly. There is also no standardized, consistent, and accepted injection protocol or chemical formulation, with many formulas being proprietary, and without scientifically valid studies documenting their safety or effectiveness or comparing one another. Injection lipolysis involves the injection of various compounds into the subcutaneous fat, but is not currently approved by the FDA for subcutaneous injection for any purpose.
“We are pleased to finally have the approval to move forward on this important clinical trial,” said V. Leroy Young, MD, chief investigator for the study. “This study is long overdue, and will go a long way toward developing more standardized protocols and ultimately improving patient safety in this area.”
The study, which was designed and funded by ASERF, will be conducted under FDA supervision and will follow patients for 46 weeks to evaluate the efficacy of one form of injection lipolysis and collect data on local and systemic reactions and any long-term complications. The study will include imaging, biochemical analysis and clinical measurements for objective evaluation of the efficacy and safety of the treatment.
“Although there are clinical reports of significant and positive results, they are all anecdotal, and unfortunately there is currently insufficient scientifically valid evidence to support the long term safety and efficacy of injection lipolysis. We hope that this study will provide the data needed to clarify some of the controversy and confusion surrounding this potentially beneficial treatment. The more we know, the better we will be able to educate and inform our patients, and recommend to them, with confidence, the safest and most effective treatments to provide them with the best results”, said Alan H. Gold, MD, president of ASERF.
According to the American Society for Aesthetic Plastic Surgery's 2006 Cosmetic Surgery Statistics, injection lipolysis procedures were performed last year on 28,901 Americans – six times the number of procedures performed the previous year.
The Aesthetic Surgery Education and Research Foundation (ASERF) is dedicated to directed research and physician education in cosmetic plastic surgery. ASERF helps to ensure the safety and effectiveness of new aesthetic (cosmetic) plastic surgical techniques and technologies by funding scientific research and clinical studies, and helps to make new treatments with proven benefits more widely available to patients who seek to improve their quality of life through aesthetic surgery. ASERF is a charitable organization, the research arm of the Society, 100% of member donations go to clinical research. www.aserf.org
The American Society for Aesthetic Plastic Surgery, the leading organization of board-certified plastic surgeons specializing in cosmetic plastic surgery. ASAPS active-member plastic surgeons are certified by the American Board of Plastic Surgery or the Royal College of Physicians and Surgeons of Canada. www.surgery.org
The 2400-member American Society for Aesthetic Plastic Surgery (ASAPS) is the only plastic surgery organization devoted entirely to the advancement of cosmetic surgery. ASAPS is recognized throughout the world as the authoritative source for cosmetic surgery education. U.S. members are certified by the American Board of Plastic Surgery. Canadian members are certified in plastic surgery by the Royal College of Physicians and Surgeons of Canada.
Toll-free referral line: 888.ASAPS.11 (272.7711). Web site: www.surgery.org
Comment by the NETWORK concerning the ASAPS Study:
We continue to welcome the conduct of a study under scientific conditions, and congratulate the ASAPS on these important and necessary activities. The term “injection lipolysis” was coined by the NETWORK-Lipolysis, Dr. Margrit Lettko, for the therapy applied by us.
We do, however, also wish to express our concerns regarding the study. If it is indeed carried out in compliance with the protocols developed by the NETWORK-Lipolysis, we have no fear of the results. But if, on the other hand, other protocols are used which are already known today to cause greater side-effects and to bring about only little therapeutic effect, then we already feel entitled to call the outcome in question.
We assume, though, that in performing the treatment, the ASAPS will at least apply the dosages and treatment intervals specified by the NETWORK standard, and that as a respected and serious society its only interest is in obtaining objective scientific data.
Concerning the compound to be used, there may be many financial incentives for changing the compound; consequently, some doctors and groupings of doctors are engaged in producing untested mixtures which should not be associated with the name “injection lipolysis”. We therefore call on and expect the ASAPS to have a compound made up on the basis of the pharmaceutical product Lipostabil N. This product has been licensed in Germany for over 30 years and contains phosphatidylcholine, desoxycholic acid and benzyl alcohol in specified concentrations. With this mixture, we have achieved best results throughout the world, and have had a need to document only very few serious side-effects. Dilution is also advised.
Provided, therefore, that the ASAPS complies with the two conditions stated above, we are confident that the study will confirm the statistical data which has been compiled by us since 2003. We are prepared to make our protocols available to the ASAPS at any time.
Dr. Franz Hasengschwandtner
Medical and Scientific Director
NETWORK-Lipolysis and ISL – International Society for Lipolysistherapy