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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05026216
Study type Interventional
Source DMR Research, PLLC
Contact
Status Enrolling by invitation
Phase Phase 4
Start date March 29, 2021
Completion date August 31, 2021

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