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 range18 Years
SexFEMALE
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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
What they're measuring
1
Number of Participants That Were 2-level Composite (CR-PCSS and PR-PCSS) Responders During the Observation Phase