VECTRA 3D Supports clinical trial results
Chicago, Illinois - LIPO-102 injections quantifiably reduced abominable fat, assessed by the Canfield VECTRA 3D system. The results of a phase 2 trial of LIPO-102 were reported by Adam Rotunda, MD, from the Newport Beach Skin Cancer Practice in California, here at the American Society for Dermatologic Surgery 2010 Annual Meeting.
Fat reduction seemed to be limited to patients who were younger than 40 years and relatively thin (skin-fold thickness <13.3 mm). The approach was minimally invasive, nonablative, and localized.
Dr. Rotunda opened his talk by stating: "I feel, in general, that injectables are the missing link in body contouring."
This study examined the safety and efficacy of an injectable aqueous combination of salmeterol xinafoate and fluticasone propionate, with the investigational moniker of LIPO-102. LIPO-102 was administered weekly, for 8 weeks, in 22 subcutaneous injections of 1 mL each into the abdomen. The effects were compared with those in individuals who received placebo injections.
The study consisted of 60 men and women 18 to 65 years of age, and was randomized and double-masked. Body mass index of the participants was between 18.5 and 28.0 kg/m2. Each 1 mL subcutaneous injection consisted of 0.05 µg/mL salmeterol and 1.0 µg/mL fluticasone, for a total weekly dose of 1.1 µg and 22 µg, respectively.
Effectiveness was measured using computer-analyzed 3-dimensional measurements of abdominal circumference and volume. The treatment group experienced reductions in abdominal circumference, relative to the control group (-1.23 vs -0.1 cm; P = .048), and reductions abdominal volume (-183 vs +24 cc; P = .023). One third of patients in the treatment group (32%) lost more than 2 cm in abdominal circumference, compared with only 5% of patients in the placebo group.
Stephen H. Mandy, MD, professor of dermatology at the University of Miami, Florida, discussed the findings with Medscape Medical News, and noted that there is "a lot of interest in [injection lipolysis], but so far there is no [US Food and Drug Administration-approved] product and there is no certainty that they will find anything."
Dr. Rotunda reports a consultancy with Lithera, Kythera Biopharma, and Allergan; ownership interest in Allergan and Kythera stock; and receiving speaking honoraria from Kythera, Lithera, and Allergan. Dr. Mandy has disclosed no relevant financial relationships.
American Society for Dermatologic Surgery (ASDS) 2010 Annual Meeting: Session CS228. Presented October 22, 2010.
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