NCT03526549

Long-Term Study of EN3835 (CCH-aaes) in Edematous Fibrosclerotic Panniculopathy (Cellulite)

A Phase 3b, Open-Label, Long-Term Study to Evaluate the Safety and Temporal Pattern of Response of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 483 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 3b, Open-Label Extension Study to evaluate safety and how long response of EN3835 (Collagenase Clostridium Histolyticum \[CCH\]-aaes) lasts in the treatment of Cellulite.

Detailed description

This study included participants who completed EN3835-302 (NCT03428750) or EN3835-303 (NCT03446781) double-blind parent studies. The first part of this study consisted of an observational period conducted in a blinded fashion and where no treatments were administered between Day 71 of the parent studies and Day 180 in this Open-label extension study. Once these participants were unblinded at Day 180, only participants who received active CCH-aaes in the parent studies remained in this study and those who received placebo in the parent studies were not eligible to continue in the Open-label study. Assessments made at the Day 71/(End of Study \[EOS\]) visit of the parent studies served as initial screening assessments for this study. In the Open-label Phase of the study, all participants who qualified for, and opted for, retreatment were administered CCH-aaes at 3 treatment sessions at 21-day intervals.

Conditions

• Edematous Fibrosclerotic Panniculopathy
• Cellulite

Interventions

Type	Name	Description
BIOLOGICAL	CCH-aaes	Administered to participants who qualified for, and opted for, retreatment.
OTHER	Observation	No treatment administered during 180 days of observation.

Timeline

• Start date: 2018-04-26
• Primary completion: 2021-10-08
• Completion: 2021-10-08
• First posted: 2018-05-16
• Last updated: 2023-09-08
• Results posted: 2023-09-08

Locations

42 sites across 1 country: United States

Regulatory

• FDA-regulated drug study