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NCT04381117 · ClinicalTrials.gov registry record
Long-term Durability Study of Collagenase Clostridium Histolyticum (CCH)
A clinical trial of Edematous Fibrosclerotic Panniculopathy, sponsored by Endo Pharmaceuticals.
- Completed
- Registry status
- 7
- Enrollment target
- 4
- Study locations
NCT04381117: Completed study of Edematous Fibrosclerotic Panniculopathy, sponsored by Endo Pharmaceuticals.
NCT04381117 is a study of Edematous Fibrosclerotic Panniculopathy that has completed, run by Endo Pharmaceuticals. The registered enrollment target is 7 participants, below the 224-participant average among 3 other Edematous Fibrosclerotic Panniculopathy trials with a reported enrollment target (97% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04381117, a study of Edematous Fibrosclerotic Panniculopathy, has completed, sponsored by Endo Pharmaceuticals.
- COMPLETED
- Registry status
- 7 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study will evaluate the long-term safety and duration of efficacy of CCH in the treatment of women with cellulite. This study will be a single day evaluation, approximately 48 months after the first dose of study drug was received in the EN3835-201.
Primary Outcome
Clinician Reported-Photonumeric Cellulite Severity Scale is a 5-level photonumeric scale with ratings ranging from 0 (None) to 4 (Severe)
Conditions Studied
Interventions
- DRUG Previously Treated with EN3835
Study Locations (4)
Florida
- Clinical Trial Site #4 - Clearwater
- Endo Clinical Trial Site #2 - Coral Gables
Missouri
- Endo Clinical Trial Site #3 - Washington
New York
- Endo Clinical Trial Site #1 - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2020-05-06 |
| Est. Completion | 2020-06-22 |
What the finished NCT04381117 record still lists
NCT04381117 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 224-participant average among 3 other Edematous Fibrosclerotic Panniculopathy trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Edematous Fibrosclerotic Panniculopathy appearing as the primary indexed condition, and to 1 intervention - of which Previously Treated with EN3835 is the first listed.
NCT04381117 reports a single indexed study location in Florida, Missouri, New York.
Frequently Asked Questions
What is clinical trial NCT04381117 about?
NCT04381117 is a clinical study titled "Long-term Durability Study of Collagenase Clostridium Histolyticum (CCH)". This study will evaluate the long-term safety and duration of efficacy of CCH in the treatment of women with cellulite. This study will be a single day evaluation, approximately 48 months after the first dose of study drug was received in the EN3835-201.
What is the current status of trial NCT04381117?
This trial is currently completed. The enrollment target is 7 participants. The study started on 2020-05-06. Estimated completion is 2020-06-22.
What conditions does trial NCT04381117 study?
This clinical trial studies the following conditions: Edematous Fibrosclerotic Panniculopathy.
What interventions are being tested in trial NCT04381117?
The interventions under investigation include: Previously Treated with EN3835 (DRUG).
Who is sponsoring clinical trial NCT04381117?
This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04381117 being conducted?
This trial has 4 study locations across Florida, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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