To Assess the Effectiveness of Multiple Dose, Multiple Concentrations of Qwo, for the Treatment of Mild to Moderate Cellulite.

Summary

This is a single center, off-label, multiple dose, multiple injection areas, Phase 4 study to assess the safety and efficacy of multi-dilution CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP). 5 subjects will be screened and dosed in the buttock and thigh areas using a multi-dilution injection technique. Qualified subjects (determined by investigator assessment) will receive a single vial of 0.84 mg of CCH to treatment areas (buttocks and thighs) for a total dose of 1.68 mg in both buttocks and both thighs per treatment session × 3 treatment sessions (Day 1, Day 22, and Day 43). Subjects will have follow-up visits at approximately 90 after Day 1.

Timeline

Start

2021-03-29

Primary completion

2021-08-15

Completion

2021-08-31

Drugs

Indications