CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 375 enrolled
Drug / intervention
COLLAGENASE CLOSTRIDIUM HISTOLYTICUM +1 morebiological
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Female ≥18 years of age
  • ✓At least 1 quadrant with moderate or severe cellulite (PR-PCSS score 3-4 and CR-PCSS score 3-4) and Hexsel CSS score ≤13 at both screening and Day 1 visits
  • ✓Willing to apply sunscreen to treatment quadrant throughout study
  • ✓Good health based on medical history, physical exam, and labs at screening
Key exclusion· 10
  • ✕Thyroid disease unless controlled with medication for ≥6 months
  • ✕Uncontrolled diabetes mellitus or hypertension
  • ✕Vascular disorder (phlebitis or varicose veins) in treatment area
  • ✕Cushing's disease or systemic corticosteroids >5 mg prednisone daily (or equivalent)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02724644
NCT02724644Phase 2Completed
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EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)

Endo Pharmaceuticals·interventional·Posted Mar 31, 2016·Updated Nov 6, 2017

In Brief

A Phase 2 clinical trial evaluating COLLAGENASE CLOSTRIDIUM HISTOLYTICUM and Placebo Comparator for Edematous Fibrosclerotic Panniculopathy and Cellulite. Completed, enrolled 375 participants across 16 sites.

Detailed Summary

The study will evaluate the safety, effectiveness, and immunogenicity of EN3835 in the treatment of adult women with Edematous Fibrosclerotic Panniculopathy (Commonly known as Cellulite).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEdematous Fibrosclerotic Panniculopathy, Cellulite
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 31, 2016
Enrollment StartFeb 1, 2016
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.3 years ago

Interventions

COLLAGENASE CLOSTRIDIUM HISTOLYTICUMbiological

Injectable intervention

Placebo Comparatorbiological