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Auxilium Pharmaceuticals, Inc. Announces First Patient Dosed in Phase 2a Cellulite Study of Collegenase Clostridium Histolyticum
Date:10/23/2013

treatments are beneficial.[iv]

"Cellulite can affect the appearance of women's skin, causing undue bother and self-consciousness in some women," said Dr. James Tursi, Chief Medical Officer at Auxilium.  "With many current treatment options not showing benefit and with no FDA approved options, we believe that CCH, if successful in clinical trials, could lead to the first FDA-approved, office-based biological treatment option for cellulite that is supported by scientific results.  We look forward to increasing our understanding of the use of CCH for this common disorder."

The Phase 2a study is a randomized, double-blind multiple-dose study that is expected to enroll approximately 144 women between the ages of 18 and 45 in the United States.  Treatment effectiveness will be evaluated by investigator and patient assessments, as well as 3-D photographic imaging techniques.  Safety will be evaluated through the collection of adverse events.  To qualify for the study, participants must have EFP in the posterolateral thighs and/or buttocks for at least 12 months prior to a screening visit.  Each subject may receive up to three treatment sessions of study drug according to randomization and each treatment session will be approximately 21 days apart.  In this study, only the dimples treated on Day 1 may be retreated on Day 22 (Treatment Session 2) and Day 43 (Treatment Session 3) if, in the opinion of the investigator, the dimple continues to be evident.  A variable number of dimples may be treated within one treatment quadrant.

Following screening and determination of eligibility, study participants will be assigned to one of four groups that vary in treatment dose (low, medium, high, and placebo).  Subjects will be randomized to low-dose CCH, mid-dose CCH, high-dose CCH, or placebo in a 5:5:5:3 ratio.  Total treatment doses per treatment session inc
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SOURCE Auxilium Pharmaceuticals, Inc.
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