EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy
1 other identifier
interventional
259
1 country
15
Brief Summary
A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2016
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 5, 2016
CompletedFirst Submitted
Initial submission to the registry
October 20, 2016
CompletedFirst Posted
Study publicly available on registry
October 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2018
CompletedResults Posted
Study results publicly available
November 24, 2020
CompletedNovember 24, 2020
November 1, 2020
1.7 years
October 20, 2016
August 5, 2020
November 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) is a 5-level scale ranging from "0" (None) to "4" (Severe). A 2-level composite responder is a participant that received EN3835 with a reduction (decrease in score) in severity of at least 2-levels from baseline on both the CR-PCSS and the PR-PCSS at a particular visit. Observation Phase is defined as the time period from Screening to the first treatment date of the same treatment area in Study EN3835-202, or the end of Study EN3835-202 if there was no treatment received for the same treatment area in Study EN3835-202. Three participants were discontinued from the study after Day 180, percentages are based on the observed counts.
Day 180 to Day 360
Secondary Outcomes (15)
Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase
Day 180 to Day 360
Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase
Day 540 to Day 720
Number of Participants That Were 1-level Composite (CR-PCSS and PR-PCSS) Responders During the Long-term Durability Phase
Day 540 to Day 720
CR-PCSS Change From Baseline (in EN3835-201 Study) by Visit During the Observation Phase
Baseline (in EN3835-201 Study) to Observation Day 360
CR-PCSS Change From Baseline (BL) by Visit During the Treatment Phase for Participants With a Second EN3835 Treatment
Day 22 to Day 360
- +10 more secondary outcomes
Other Outcomes (5)
Overall Serum Antibody at Observation Visit Day 360
Day 360
Overall Antibody Log Titer Levels at Observation Visit Day 360
Day 360
Neutralizing Antibodies at Observation Visit Day 360
Day 360
- +2 more other outcomes
Study Arms (1)
EN3835 Active
EXPERIMENTALEN3835 0.84mg (Collagenase Clostridium Histolyticum)
Interventions
Eligibility Criteria
You may qualify if:
- Voluntarily sign and date an informed consent agreement
- Have participated in and completed the double-blind study EN3835-201
- Be willing to apply sunscreen to any treated quadrant before each exposure to sun
- Voluntarily sign and date an informed consent agreement
- Have participated in and completed the double-blind study EN3835-201
- Be willing to apply sunscreen to any treated quadrant before each exposure to sun
- Have at least 1 quadrant with: a score of 3 or 4 (moderate or severe) as reported on the PCSS (Photonumeric Cellulite Severity Scale) by the subject or investigator, and a Hexsel CSS (Cellulite Severity Scale) score no greater than 13
- Be judged to be in good health
- Have a negative urine pregnancy test at screening and be using an effective contraception method, be surgically sterile, or post-menopausal
You may not qualify if:
- None
- Has used, or intends to use during the course of the study, other treatment of EFP on the legs or buttocks
- Is presently nursing a baby or providing breast milk for a baby
- Intends to become pregnant during the study
- Currently receiving, has received within 7 days before injection of study drug, or plans to receive an anticoagulant or antiplatelet medication
- History of stroke or bleeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Endo Clinical Trial Site #1
Beverly Hills, California, 90210, United States
Endo Clinical Trial Site #2
Murrieta, California, 92562, United States
Endo Clinical Trial Site #3
Oceanside, California, 92056, United States
Endo Clinical Trial Site #4
San Diego, California, 92121, United States
Endo Clinical Trial Site #5
Clearwater, Florida, 33756, United States
Endo Clinical Trial Site #6
Coral Gables, Florida, 33146, United States
Endo Clinical Trial Site #7
Palm Beach, Florida, 33401, United States
Endo Clinical Trial Site #8
Washington, Missouri, 63091, United States
Endo Clinical Trial Site #10
New York, New York, 10065, United States
Endo Clinical Trial Site #9
New York, New York, 10075, United States
Endo Clinical Trial Site #11
Nashville, Tennessee, 37215, United States
Endo Clinical Trial Site #12
Pflugerville, Texas, 78660, United States
Endo Clinical Trial Site #13
Charlottesville, Virginia, 22911, United States
Endo Clinical Trial Site #14
Lynchburg, Virginia, 24501, United States
Endo Clinical Trial Site #15
Spokane, Washington, 99202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Saji Vijayan, MBBS
- Organization
- Endo Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Mike McLane
Endo Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2016
First Posted
October 21, 2016
Study Start
October 5, 2016
Primary Completion
June 14, 2018
Study Completion
June 14, 2018
Last Updated
November 24, 2020
Results First Posted
November 24, 2020
Record last verified: 2020-11