Endo International Launches New Phase 2b Study of CCH for Cellulite
A Phase 2b study of collagenase clostridium histolyticum (CCH) for the treatment of as cellulite is about to get started, Endo International plc reports.
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 U.S. Food and Drug Administration(FDA)-approved in the United States under the trade name XIAFLEX® for the treatment of adult Dupuytren’s contracture patients with a palpable cord, and adult men with Peyronie's disease with a palpable plaque and penile curvature deformity of at least 30 degrees at the start of therapy.
The Phase 2b trial is expected to enroll 350 women aged 18 years or older in the United States. Each subject will receive up to three treatment sessions of CCH (0.84 mg / session) or placebo with each treatment session occurring approximately 21 days apart. Twelve injections will be administered into cellulite dimples during each session across an entire treatment quadrant – left or right buttock or left or right posterior thigh. At both the outset and conclusion of treatment, cellulite severity will be assessed by each patient and clinician using two photonumeric cellulite severity scales developed by Endo and third-party experts and reviewed by the FDA. The scales – the Photonumeric Cellulite Severity Scale (PCSS) – are 5-point scales ranging from 0 (no cellulite) to 4 (severe cellulite) that measure improvement in the appearance of cellulite. In addition to the patient and physician assessments, an independent, blinded five-member panel of aesthetic clinicians will evaluate pre-treatment and end-of-study photo images of patients using the PCSS.
The trial's primary endpoint is the proportion of composite responders at Day 71 defined as subjects with a 2-point improvement in severity from baseline in the clinician-rated PCSS and a 2-point improvement in the patient-rated PCSS. Additional endpoints include assessment of patient and clinician satisfaction using the Global Aesthetic Improvement Scale (GAIS) and change in the Hexsel cellulite severity scale.
Results for an earlier Phase 2a trial of CCH for the treatment of cellulite demonstrated that three doses of CCH (low (0.06mg), mid (0.48mg) and high (0.84mg) showed an improvement in the appearance of cellulite as measured by the trial endpoints of an investigator and a patient score on the GAIS, which was adapted for use in cellulite. The mid and high dose groups demonstrated a statistically significant improvement in the appearance of cellulite, as measured by GAIS scores, with a p-value of <0.05 compared to placebo for both endpoints. In the mid and high dose groups, 68 percent of patients reported being "Satisfied" or "Very Satisfied" with the results of their treatment, compared to only 34 percent of patients randomized to placebo. CCH was well-tolerated by all dose groups with most adverse events being mild to moderate and primarily limited to the local injection area.