Ireland-based Endo International has started two identical Phase lll clinical trials of collagenase clostridium histolyticum (CCH) for the treatment of cellulite.
The new multicentre, double-blind, placebo-controlled Randomised EvaLuation of CEllulite Reduction by CollAgenaSE Clostridium Histolyticum (RELEASE) trials will investigate the safety and efficacy of CCH in reducing the skin condition.
The trials expect to enrol a total of 840 women, with each trial including 420 women aged 18 years or older with moderate to severe cellulite in the US.
Endo Pharmaceuticals Research and Development chief medical officer and senior vice-president Matthew Davis said: “Endo understands the social stigma and psychological impact that cellulite can have on patients, and these Phase III RELEASE studies represent our commitment to identifying the full potential of this therapy through our clinical development programme.”
As part of the trials, each subject will be given up to three treatment visits of CCH, including 0.84mg treatment area and two treatment areas per visit, or placebo. Each of visits will have a gap between of around 21 days.
Subjects will also receive 12 injections into cellulite dimples during each visit across each treatment area, including the left and right buttock.
At the beginning and ending of treatment, each patient and clinician will examine the severity of cellulite using two photonumeric cellulite severity scales developed by Endo and third-party psychometric experts.
The trials’ primary endpoint is to achieve a composite responder analysis showing at least a two-level composite improvement, independently reported by both patient and clinician on the photonumeric scales of cellulite severity.
Its major secondary endpoints are the percentage of subjects that experience at least a one-level or two-level improvement in patient-reported assessment, the percentage of subjects with a one-level composite improvement, the number of satisfied participants, as well as the change from baseline in a cellulite impact scale and others.