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Endo Starts Phase 2B Clinical Trial of Collagenase Clostridium Histolyticum in Cellulite
Feb. 17, 2016 09:41AM PST
Life Science InvestingEndo International plc (NASDAQ: ENDP, TSX: ENL) has started its Phase 2b study of collagenase clostridium histolyticum for the treatment of edematous fibrosclerotic panniculopathy, commonly known as cellulite.
Endo International plc (NASDAQ: ENDP, TSX: ENL) has started its Phase 2b study of collagenase clostridium histolyticum for the treatment of edematous fibrosclerotic panniculopathy, commonly known as cellulite.
According to the company:
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 U.S. Food and Drug Administration (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.
Dr. Susan Hall, Executive Vice President, Chief Scientific Officer and Global Head of R&D and Quality at Endo commented:
There are no FDA-approved pharmacological options for cellulite and many currently available treatment options have not demonstrated a scientific benefit. We believe that if CCH is successful in clinical trials and if approved by the FDA, it could become the first office-based biological treatment option for cellulite that is supported by scientific results. Endo is looking forward to expanding the understanding of using CCH for this aesthetic indication.