At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 483 enrolled
Drug / intervention
CCH-aaes +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating CCH-aaes and Observation for Edematous Fibrosclerotic Panniculopathy and Cellulite. Completed, enrolled 483 participants across 42 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEdematous Fibrosclerotic Panniculopathy, Cellulite
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartApr 2018
First PostedMay 2018
Primary CompletionOct 2021
TodayJul 2026
First PostedMay 16, 2018
Enrollment StartApr 26, 2018
Primary CompletionOct 8, 2021
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 8.1 years ago
Interventions
CCH-aaesbiological
Administered to participants who qualified for, and opted for, retreatment.
Observationother
No treatment administered during 180 days of observation.