- In a randomized, double-blind, phase IIa study, collagenase clostridium histolyticum (CCH) was evaluated for the treatment of cellulite. Three doses were tested.
- The Global Aesthetic Improvement Scale (GAIS) was used as the main endpoint.
- In mid- and high-dose groups, 68% of treated women reported being either ‘satisfied’ and ‘very satisfied.’
The phase IIa study evaluated CCH in 150 women aged 18 to 45, who wanted to reduce the appearance of edematous fibrosclerotic panniculopathy (EFD), also known as cellulite. There were a total of three treatment sessions, spaced approximately 21 days apart. Each injection consisted of up to 12 injections in the dimpled areas of the buttocks and thighs. CCH was well tolerated with some minor irritation at the injection site. All adverse events resolved within 21 days. Currently Auxilium is continuing to analyze data, recruit key opinion leaders and prepare to address regulatory issues.