Skin Aging

September 8, 2014

BioSpecifics Technologies released results of a phase IIa study of XIAFLEX (collagenase clostridium histolyticum or CCH) for the potential treatment of cellulite, or edematous fibrosclerotic panniculopathy. The phase IIa study enrolled 150 women between the ages of 18 and 45 in the U.S. Each subject received up to three treatment sessions of drug or placebo according to randomization: five high-dose 0.84mg, five mid 0.48mg, five low 0.06mg, three placebo. Each treatment session was approximately 21 days apart. Up to 12 injections were administered into cellulite dimples during each session across an entire treatment quadrant: left or right buttock or left or right posterior thigh. Both the mid and high-dose groups of CCH demonstrated a statistically significant improvement in investigators’ assessments of the appearance of cellulite, as measured by Global Aesthetic Improvement Scale (GAIS) scores, with a p-value of <0.05 v. placebo, as well as in patients’ assessments of the appearance of cellulite, as measured by GAIS scores, with a p-value of <0.02 v. placebo. Sixty-eight percent of both the mid and high-dose groups reported being “Satisfied” or “Very Satisfied” with their cellulite treatment, compared to only 34% of placebo patients. Both the mid and high-dose groups of CCH demonstrated a statistically significant improvement in the post-hoc composite responder analysis, as measured by combined investigator and patient GAIS scores, with p-values of 0.021 and 0.004, respectively, v. placebo.

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