NCT05026216

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

To Assess the Effectiveness of Multiple Dose, Multiple Concentrations of Clostridium Histolyticum-aases, Qwo, for the Treatment of Mild to Moderate Cellulite in Adult Females to the Buttocks and Thighs

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: DMR Research, PLLC · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cellulite

Interventions

Type	Name	Description
DRUG	Qwo	Collagenase clostridium histolyticum-aaes is a combination of bacterial collagenases AUX-I and AUX-II, in an approximate 1:1 mass ratio, which are isolated and purified from the fermentation of Clostridium histolyticum bacteria. Collagenase AUX-I is a single polypeptide chain consisting of approximately 1000 amino acids. Collagenase AUX-II is a single polypeptide chain consisting of approximately 1000 amino acids.

Timeline

• Start date: 2021-03-29
• Primary completion: 2021-08-15
• Completion: 2021-08-31
• First posted: 2021-08-30
• Last updated: 2021-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study