Trials / Completed
CompletedNCT03893890
Durability and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women
A Phase 2b, Open Label Durability Study of EN3835 Following Treatment of Edematous Fibrosclerotic Panniculopathy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 8 (actual)
- Sponsor
- Endo Pharmaceuticals · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 2b, rollover, long-term study to evaluate the safety and duration of efficacy of EN3835 in the treatment of women with EFP. Subjects who participated in and completed studies EN3835-201 and EN3835-202 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201 will be eligible for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Previously Treated with EN3835 | No treatment to be administered - Observational only |
Timeline
- Start date
- 2019-03-28
- Primary completion
- 2019-06-25
- Completion
- 2019-06-25
- First posted
- 2019-03-28
- Last updated
- 2019-07-19
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03893890. Inclusion in this directory is not an endorsement.