Endo International plc announces the publication of Phase 2 data evaluating collagenase clostridium histolyticum (CCH) for the treatment of cellulite in Dermatologic Surgery, the official journal of the American Society for Dermatologic Surgery.
CCH is reportedly the first and only 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.
Consistent with the recently released Phase 3 studies, the recently published Phase 2 data demonstrate that CCH delivered a clinically meaningful and statistically significant improvement as compared to placebo for all primary and secondary endpoints, the company states in a media release.
“The possibility of an injectable treatment for cellulite is exciting for both patients and aesthetic physicians,” says Dr Neil Sadick, lead investigator and Clinical Professor of Dermatology, Weill Cornell Medical College, in the 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 (CR-PCSS = 54.2% improvement; PR-PCSS = 72.3% improvement) 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 release explains.
“The results of this study add to the evidence that CCH, if approved, can play a significant role in reducing the appearance of cellulite,” says Matthew Davis, MD, RPh, Endo’s Senior Vice President and Chief Medical Officer, in the release.
“The Phase 2 and Phase 3 data continue to substantiate our ongoing efforts to develop an injectable treatment for cellulite.”
[Source(s): Endo International plc, PR Newswire]