NCT05419505

Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks

APHRODITE-1: A Phase 2, Open Label, Self-Controlled Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks in Adult Females

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate the effect of different doses, strengths (concentrations), diluent additives, depths of injection, and methods of injection on the severity of bruising potentially induced by QWO (collagenase clostridium histolyticum-aaes \[CCH-aaes\]).

Detailed description

The study will comprise a Screening Period (28 days), Treatment Period (90 days), and Follow-up Period (90 days). Participants will receive CCH-aaes in different doses, concentrations, diluent additives, depths of injection, and methods of injection in a split buttock arrangement, with the right buttock serving as the control, and the left buttock (investigational side) receiving a study intervention.

Conditions

• Edematous Fibrosclerotic Panniculopathy
• Cellulite

Interventions

Type	Name	Description
DRUG	CCH-aaes	Administered by subcutaneous injection.
DRUG	Antifibrinolytic Agent	Self-administered by participants enrolled in Cohort 7.

Timeline

• Start date: 2022-06-15
• Primary completion: 2023-01-03
• Completion: 2023-06-21
• First posted: 2022-06-15
• Last updated: 2025-03-07
• Results posted: 2025-03-07

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study