NCT03428750

Effectiveness and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of EN3835 In The Treatment Of Edematous Fibrosclerotic Panniculopathy (Cellulite)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 423 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Subjects will be screened for study eligibility within 14 days prior to enrolling in this study. Subjects with 2 treatment areas (bilateral buttocks) with moderate or severe levels of cellulite as independently assessed by the subject using the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) and by the Investigator using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) will be eligible. The eligibility of the buttocks will be confirmed on Day 1. Once the eligibility of the buttocks is confirmed, subjects will be randomly assigned to a treatment group (EN3835 0.84 mg per buttock or placebo) in a 1:1 ratio within an investigational site. Each subject will receive a treatment course which consists of up to 3 treatment visits (sessions), separated by 21 days (ie, Days 1, 22, and 43). Each treatment visit will consist of 12 injections (0.3 mL per injection of EN3835 0.07 mg/injection or placebo; 0.84 mg in 3.6 mL per buttock) in each of the two buttocks for a total volume of 7.2 mL (1.68 mg). Selection of dimples to be treated in the buttocks will be at the discretion of the Investigator. End of study will occur at study day 71.

Conditions

• Edematous Fibrosclerotic Panniculopathy (Cellulite)

Interventions

Type	Name	Description
BIOLOGICAL	EN3835	Collagenase clostridium histolyticum
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2018-02-05
• Primary completion: 2018-09-26
• Completion: 2018-09-26
• First posted: 2018-02-12
• Last updated: 2020-10-08
• Results posted: 2020-10-08

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study