Date: 2016-02-17
Type of information: Initiation of the trial
phase: 2b
Announcement: initiation of the trial
Company: Endo International (USA - PA)
Product: Xiapex®(EU)/ Xiaflex® (USA) collagenase clostridium histolyticum
Action
mechanism: enzyme. Xiapex®(EU)/ Xiaflex® (USA) (collagenase clostridium histolyticum) is a biologic approved in the U.S., EU, Canada, Australia and Japan for the treatment of adult Dupuytren\'s contracture (DC) patients with a palpable cord and in the U.S. and EU for the treatment of adult men with Peyronie\'s disease (PD) with a palpable plaque and penile curvature deformity of at least 30 degrees at the start of therapy. XIAFLEX® consists of a combination of two subtypes of collagenase, derived from Clostridium histolyticum. Together, the collagenase subtypes are thought to work synergistically to break the bonds of the collagen structure.
Disease: edematous fibrosclerotic panniculopathy, commonly known as cellulite
Therapeutic area: Inflammatory diseases
Country: USA
Trial details:
Latest
news: * On February 17, 2016, Endo International announced the initiation of its Phase 2b study of collagenase clostridium histolyticum for the treatment of edematous fibrosclerotic panniculopathy, commonly known as cellulite. 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 trained aesthetic clinicians will evaluate pre-treatment and end-of-study photo images of patients using the PCSS. The Phase 2b 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 collagenase clostridium histolyticum 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. Collagenase clostridium histolyticum was well-tolerated by all dose groups with most adverse events (AEs) being mild to moderate and primarily limited to the local injection area.
