Clinical Trial Update: The first cohort of patients in a trial of XIAFLEX® (collagenase clostridium histolyticum) for the treatment of “cottage cheese thighs” or cellulite have been dosed, reports XIAFLEX manufacturer Auxilium Pharmaceuticals, Inc. of Malvern, Penn.
Approved to treat Dupuytren’s contracture when a "cord" can be felt, XIAFLEX treatment targets and lyses collagen tethers to release skin dimpling; potentially resulting in smoothing of the skin. The phase Ib trial is a single site, open-label dose-escalation study. Auxilium is planning to enroll 63 women aged 21 to 60. Topline results are expected in the second half of 2012.
“For many women, cellulite can be a source of considerable embarrassment or self-consciousness,” said Dr. James Tursi, Chief Medical Officer at Auxilium, in a press release. “Current treatments of cellulite with creams, light-based procedures or liposuction provide limited or no effectiveness. The clinical development of XIAFLEX, if successful, could lead to the first FDA-approved, office-based.”
Study participants must have cellulite in the posterolateral thighs and/or buttocks for at least 12 months prior to a screening visit. Women will be assigned to one of seven groups that vary in treatment dose, injection concentration and volume. Participants will receive 10 concurrent injections (0.1 or 0.5 mL per injection) of XIAFLEX via a standardized template over a targeted area of cellulite. The total dose administered into the targeted area will range between 0.0029 mg and 0.116 mg. This represents between 0.5% and 20% of the dose used in a single injection to treat Dupuytren’s contracture Treatment effectiveness will be evaluated by investigator and patient assessments and 3-D imaging. Stay tuned.
Source: Auxilium Pharmaceuticals, Inc