Effectiveness and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women
Public ClinicalTrials.gov record NCT03428750. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of EN3835 In The Treatment Of Edematous Fibrosclerotic Panniculopathy (Cellulite)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03428750
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 423 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 5, 2018 (Actual)
- Primary completion
- Sep 26, 2018 (Actual)
- Completion
- Sep 26, 2018 (Actual)
- Last update posted
- Oct 8, 2020
2018
United States locations
- U.S. sites
- 26
- U.S. states
- 14
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Endo Clinical Trial Site #1 | Scottsdale | Arizona | 85258 | — |
| Endo Clinical Trial Site #2 | Encinitas | California | 92024 | — |
| Endo Clinical Trial Site #3 | Long Beach | California | 90806 | — |
| Endo Clinical Trial Site #4 | Los Angeles | California | 90025 | — |
| Endo Clinical Trial Site #5 | Oceanside | California | 92056 | — |
| Endo Clinical Trial Site #6 | San Diego | California | 92121 | — |
| Endo Clinical Trial Site #7 | Boca Raton | Florida | 33486 | — |
| Endo Clinical Trial Site #8 | Largo | Florida | 33770 | — |
| Endo Clinical Trial Site #9 | Miami | Florida | 33185 | — |
| Endo Clinical Trial Site #10 | Snellville | Georgia | 30078 | — |
| Endo Clinical Trial Site #11 | Chicago | Illinois | 60654 | — |
| Endo Clinical Trial Site #12 | New Orleans | Louisiana | 70115 | — |
| Endo Clinical Trial Site #13 | Chestnut Hill | Massachusetts | 02467 | — |
| Endo Clinical Trial Site #14 | Quincy | Massachusetts | 02169 | — |
| Endo Clinical Trial Site #15 | Fridley | Minnesota | 55432 | — |
| Endo Clinical Trial Site #16 | Washington | Missouri | 63090 | — |
| Endo Clinical Trial Site #17 | Omaha | Nebraska | 68144 | — |
| Endo Clinical Trial Site #18 | Mount Kisco | New York | 10549 | — |
| Endo Clinical Trial Site #21 | New York | New York | 10022 | — |
| Endo Clinical Trial Site #19 | New York | New York | 10065 | — |
| Endo Clinical Trial Site #20 | New York | New York | 10075 | — |
| Endo Clinical Trial Site #22 | Cincinnati | Ohio | 45249 | — |
| Endo Clinical Trial Site #23 | Houston | Texas | 77056 | — |
| Endo Clinical Trial Site #24 | Pflugerville | Texas | 78660 | — |
| Endo Clinical Trial Site #25 | Sugar Land | Texas | 77497 | — |
| Endo Clinical Trial Site #26 | Charlottesville | Virginia | 22911 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03428750, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 8, 2020 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03428750 live on ClinicalTrials.gov.