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Investigational New Drug Application for 'Fat Melting' Injections Cleared by the FDA
Date:9/4/2007

Clinical trial on injection lipolysis treatment to begin soon

NEW YORK, Sept. 4 /PRNewswire-USNewswire/ -- 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 ther
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SOURCE Aesthetic Surgery Education and Research Foundation
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