Auxilium announced positive results from a Phase 2a study of Xiaflex (collagenase clostridium histolyticum [CCH]) for the treatment of edematous fibrosclerotic panniculopathy (EEP), also known as cellulite.
The trial was a randomized, double-blind study in 150 women. Each participant received up to three treatment sessions of CCH or placebo according to randomization (5 high-dose: 5 mid: 5 low: 3 placebo) and each treatment session was approximately 21 days apart. Up to 12 injections were administered into cellulite dimples during each session across an entire treatment quadrant, left or right buttock or left or right posterior thigh. Only the dimples treated on Day 1 were able to be retreated on Day 22 (Treatment Session 2) and Day 43 (Treatment Session 3) if, in the opinion of the investigator, the dimple continued to be evident.
Key Phase 2a trial results include:
- Both the mid and high dose groups of CCH demonstrated a statistically significant improvement in investigators’ assessments of the appearance of cellulite, as measured by GAIS scores, with a p-value of <0.05 vs. placebo.
- Both the mid and high dose groups of CCH demonstrated a statistically significant improvement in patients’ assessments of the appearance of cellulite, as measured by GAIS scores, with a p-value of <0.02 vs. placebo.
- 68% of both mid and high dose patients reported being “Satisfied” or “Very Satisfied” with their cellulite treatment, compared to only 34% of placebo patients.
- Both the mid and high dose groups of CCH demonstrated a statistically significant improvement in the post-hoc composite responder analysis, as measured by combined investigator and patient GAIS scores, with p-values of 0.021 and 0.004, respectively, vs. placebo.
- While the trial was not designed to quantify changes in cellulite dimple measurements, 3-D photography was utilized to enable visualization of treatment effects.
Xiaflex is already approved for Dupuytren’s contracture with palpable cord and Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. Currently Xiaflex is in Phase 2 development for cellulite and Frozen Shoulder Syndrome.
For more information call (877) 663-0412 or visit Auxilium.com.