Durability and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women
Completed
Conditions studied: Edematous Fibrosclerotic Panniculopathy
In brief
This is a Phase 2b, rollover, long-term study to evaluate the safety and duration of efficacy of EN3835 in the treatment of women with EFP. Subjects who participated in and completed studies EN3835-201 and EN3835-202 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201 will be eligible for this study.
Key facts
- Study ID
- NCT03893890
- Run by
- Endo USA Inc., a Keenova Therapeutics Company
- People needed
- 8
- Starts
- 2019-03-28
- Expected to finish
- 2019-06-25
- Last updated by the study team
- 2019-07-19
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- To qualify for the study a subject must:
- Be able to provide voluntary written informed consent prior to the initiation of any study-specific procedures per the policy of the governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
- Have participated in and completed both studies EN3835-201 and EN3835-202 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201.
- Be willing and able to comply with all protocol required visits and assessments.
You may not qualify if…
- Subjects will be ineligible for participation in this study if the subject:
- Has had retreatment with EN3835 in the area initially treated during the EN3835-201 study since the completion of study EN3835-202.
- Has had liposuction on the body region treated during the EN3835-201 study since the completion of that study.
- Has had any of the following in the area initially treated during the EN3835-201 study since the completion of that study.
- Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or surgery (including subcision and/or powered subcision).
- Any investigational treatment for EFP/cellulite.
- Endermologie® or similar treatments.
- Massage therapy.
- Creams (eg, Celluvera™, TriLastin®).
- Any other condition(s) that, in the Investigator's opinion, might indicate the subject is unsuitable for the study.
Where it is running
- Endo Clinical Trial Site #4 — Clearwater, Florida, United States
- Endo Clinical Trial Site #1 — Coral Gables, Florida, United States
- Endo Clinical Trial Site #5 — Washington, Missouri, United States
- Endo Clinical Trial Site #2 — New York, New York, United States
- Endo Clinical Trial Site #3 — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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