Long-term Durability Study of Collagenase Clostridium Histolyticum (CCH)
Completed
Conditions studied: Edematous Fibrosclerotic Panniculopathy
In brief
This study will evaluate the long-term safety and duration of efficacy of CCH in the treatment of women with cellulite. This study will be a single day evaluation, approximately 48 months after the first dose of study drug was received in the EN3835-201.
Key facts
- Study ID
- NCT04381117
- Run by
- Endo USA Inc., a Keenova Therapeutics Company
- People needed
- 7
- Starts
- 2020-05-06
- Expected to finish
- 2020-06-22
- Last updated by the study team
- 2024-01-02
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Have participated in and completed studies EN3835-201, EN3835-202 and EN3835-219 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 cooperate with the requirements of the study.
You may not qualify if…
- Has had retreatment with CCH in the area initially treated during the EN3835-201 study since the completion of study EN3835-219.
- Has received collagenase treatments (eg, Santyl® Ointment and/or Xiaflex®/Xiapex®) since the completion of study EN3835-219.
- Has had liposuction on the body region treated during the EN3835-201 study since the completion of that study.
- Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment in the area treated during the EN3835-201 study since the completion of that study.
- Has any other condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.
Where it is running
- Clinical Trial Site #4 — Clearwater, Florida, United States
- Endo Clinical Trial Site #2 — Coral Gables, Florida, United States
- Endo Clinical Trial Site #3 — Washington, Missouri, United States
- Endo Clinical Trial Site #1 — New York, New York, United States
Full record on ClinicalTrials.gov
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