Endo International plc’s injectable cellulite treatment collagenase clostridium histolyticum ("CCH") showed a clinically meaningful and statistically significant improvement compared to placebo for all primary and secondary endpoints in a Phase 2 study.
The findings, which appear in Dermatologic Surgery, are consistent with the recently released Phase 3 studies.
CCH is an investigational injectable treatment designed specifically to reduce the appearance of cellulite by disrupting the collagen structure of fibrous septae, which cause dimpling of the skin.
"The possibility of an injectable treatment for cellulite is exciting for both patients and aesthetic physicians," says Neil Sadick, MD lead investigator and Clinical Professor of Dermatology, Weill Cornell Medical College, in a news release. "As the clinical trial program for CCH advances, each new study and its corresponding data analysis demonstrate that CCH could be a major advancement in treating an issue that affects a majority of women during their lifetime."
The Phase 2 clinical trial enrolled 375 women aged 18 years or older in the United States who were randomized to 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 were administered into cellulite dimples during each session across an entire treatment area – left or right buttock, or left or right posterior thigh. A significant percentage of trial subjects receiving CCH achieved at least a 1-point improvement of cellulite severity. CCH was well-tolerated in the treated subjects with most adverse events being mild to moderate in severity, and primarily limited to the local injection area (e.g. bruising, pain, nodule, pruritus, erythema, and discoloration).
"The results of this study add to the evidence that CCH, if approved, can play a significant role in reducing the appearance of cellulite," adds Matthew Davis, MD, RPh, Endo's Senior Vice President and Chief Medical Officer. "The Phase 2 and Phase 3 data continue to substantiate our ongoing efforts to develop an injectable treatment for cellulite."