Auxilium Pharmaceuticals (NASDAQ:AUXL) announces the results from a Phase 2a clinical trial evaluating the safety and efficacy of injections of collagenase clostridium histolyticum (CCH) for the treatment of cellulite (edematous fibrosclerotic panniculopathy). Three doses (low-0.06mg; mid-0.48mg; high-0.84mg) of CCH showed an improvement in the appearance of cellulite as measured by investigator- and patient-generated scores on the Global Aesthetic Improvement Scale (GAIS).
The mid and high dose groups demonstrated a statistically significant improvement in the appearance of cellulite (measured by GAIS scores) with a p-value of <0.05. In these two groups, 68% of patients rated themselves "satisfied" or "very satisfied" with the results compared to 34% in the placebo cohort.
Dulling the veneer of the results is the fact that the trial is based on subjective observational data, as evidenced by the 34% satisfied/very satisfied proportion of the control group. The results would be more robust if the reduction in cellulite was independently quantified. Also, the p-value, ideally, would be <0.01 or less.