At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 153 enrolled
Drug / intervention
EN3835drug
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 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
In Brief
A Phase 3 clinical trial evaluating EN3835 for Edematous Fibrosclerotic Panniculopathy (EFP) and Cellulite. Completed, enrolled 153 participants across 12 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartNov 2019
First PostedNov 2019
Primary CompletionOct 2020
Study CompletionJan 2021
TodayJul 2026
First PostedNov 20, 2019
Enrollment StartNov 1, 2019
Primary CompletionOct 6, 2020
Study CompletionJan 8, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.6 years ago
Interventions
EN3835drug
Collagenase Clostridium Histolyticum (CCH)