NCT04170296

Real World CCH Study in Adult Females With Cellulite

A Real World, Multicenter, Open-Label, Multiple Dose Study to Assess the Effectiveness of, and Satisfaction With, CCH Treatment of Buttocks or Thigh Cellulite in Adult Females

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter, open-label, multiple dose, 2 cohort, Phase 3b study to assess the safety and efficacy of CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP). Cohort 1 will include approximately 80 subjects with mild or moderate EFP in the posterolateral thighs and Cohort 2 will include approximately 70 subjects with mild or moderate EFP in the buttocks.

Conditions

• Edematous Fibrosclerotic Panniculopathy (EFP)
• Cellulite

Interventions

Type	Name	Description
DRUG	EN3835	Collagenase Clostridium Histolyticum (CCH)

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-10-06
• Completion: 2021-01-08
• First posted: 2019-11-20
• Last updated: 2022-02-22
• Results posted: 2022-02-22

Locations

12 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study