EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite) (NCT02942160) | Clinical Trial Compass
CompletedPhase 2
EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
United States259 participantsStarted 2016-10-05
Plain-language summary
A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (commonly known as Cellulite).
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for Observation Phase:
* 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
Inclusion Criteria for Treatment Phase:
* 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
Exclusion Criteria for Observation Phase:
* None
Exclusion Criteria for Treatment Phase:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase
Timeframe: Day 180 to Day 360
Trial details
NCT IDNCT02942160
SponsorEndo USA Inc., a Keenova Therapeutics Company