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NCT03428750 · ClinicalTrials.gov registry record · Phase 3
Effectiveness and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women
A Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 423
- Enrollment target
NCT03428750: Completed Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
NCT03428750 is a Phase 3 study that has completed, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 423 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03428750, a Phase 3 study, has completed, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 423 participants
- Enrollment target
Study Summary
Subjects will be screened for study eligibility within 14 days prior to enrolling in this study. Subjects with 2 treatment areas (bilateral buttocks) with moderate or severe levels of cellulite as independently assessed by the subject using the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) and by the Investigator using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) will be eligible. The eligibility of the buttocks will be confirmed on Day 1. Once the eligibility of the buttocks is confirmed, subjects will be randomly assigned to a treatment group (EN3835 0.84 mg per buttock or placebo) in a 1:1 ratio within an investigational site. Each subject will receive a treatment course which consists of up to 3 treatment visits (sessions), separated by 21 days (ie, Days 1, 22, and 43). Each treatment visit will consist of 12 injections (0.3 mL per injection of EN3835 0.07 mg/injection or placebo; 0.84 mg in 3.6 mL per buttock) in each of the two buttocks for a total volume of 7.2 mL (1.68 mg). Selection of dimples to be treated in the buttocks will be at the discretion of the Investigator. End of study will occur at study day 71.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL EN3835
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 423 participants |
| Start Date | 2018-02-05 |
| Est. Completion | 2018-09-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03428750
The ClinicalTrials.gov registry entry for NCT03428750 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 423 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endo USA Inc., a Keenova Therapeutics Company, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03428750 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03428750 about?
NCT03428750 is a clinical study titled "Effectiveness and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women". Subjects will be screened for study eligibility within 14 days prior to enrolling in this study. Subjects with 2 treatment areas (bilateral buttocks) with moderate or severe levels of cellulite as independently assessed by the subject using the Patient Reported Photonumeric Cellulite Severity Scale ...
What is the current status of trial NCT03428750?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 423 participants. The study started on 2018-02-05. Estimated completion is 2018-09-26.
What interventions are being tested in trial NCT03428750?
The interventions under investigation include: Placebo (BIOLOGICAL), EN3835 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03428750?
This trial is sponsored by Endo USA Inc., a Keenova Therapeutics Company, which has 61 total clinical trials registered on ClinicalTrials.gov.
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