A DYNAMIC APPROACH TO
LEADING THE LARGEST CELLULITE CLINICAL TRIALS IN THE US
Designing an innovative treatment for cellulite began with pursuing the bold research that exemplifies our philosophy of redefining scientific artistry.
We completed the phase 3 studies for our cellulite injectable in two identical, multicenter, randomized, double-blind, placebo-controlled studies called RELEASE trials 1 and 2.
RELEASE TRIAL 1: 423
RELEASE TRIAL 2: 422
Each patient received up to 3 treatments, occurring ~21 days apart, of the cellulite injectable or placebo. At Day 71, the differences in physician- and patient-reported responses on the photonumeric cellulite severity scale (PCSS) at the outset and conclusion of the trial were evaluated.
Physicians and patients were asked, independently, to assess the appearance of cellulite in the target buttock on a photonumeric scale before and after treatment.
We developed this 5-level scale with third-party psychometric experts to describe the severity of the appearance of cellulite. This scale ranges from 0 to 4, in increasing order of severity.
Photonumeric Cellulite Severity Scale
Physician-reported improvement in PCSS score
Patient-reported improvement in PCSS score
The primary endpoint was the percentage of subjects who had a 2-level improvement on both the patient- and physician-reported scales.
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