The first patient in a phase 2a study of collagenase clostridium histolyticum (or “CCH”) for the treatment of edematous fibrosclerotic panniculopathy (“EFP”) or cellulite has been dosed, reports Auxilium Pharmaceuticals Inc. The study will include about 144 women, and topline results are expected in the first quarter of 2015.Dimpled appearance of cellulite opt

While many energy-based therapies, creams, and potions promise to get rid of cellulite, there is little evidence that any of them work well or for long.

CCH is intended to target and lyse collagen tethers with the goal of releasing the skin dimpling and potentially resulting in smoothing of the skin. CCH is currently approved in the United States under the trade name XIAFLEX® for the treatment of adult Dupuytren’s contracture patients with a palpable cord, and is awaiting a decision from the federal Food and Drug Administration FDA for use in Peyronie’s disease.

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 3D 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). Total treatment doses per treatment session include doses both lower and higher than the dose used in Dupuytren’s contracture with a palpable cord. This study will be conducted in two stages. If the safety and local tolerability profile from the first stage has been found to be acceptable, subjects will be enrolled in stage 2.

Previously, a Phase1b open label dose-ranging study results demonstrated that some doses of CCH provided potential improvement in the cellulite target dimple volume following a single injection into that dimple. The most common adverse events (>10%) in this study included injection site bruising and pain.