Status:
COMPLETED
Long-term Durability Study of Collagenase Clostridium Histolyticum (CCH)
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Edematous Fibrosclerotic Panniculopathy
Eligibility:
FEMALE
18+ years
Brief Summary
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 fi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 6 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 22 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04381117
Start Date
May 6 2020
End Date
June 22 2020
Last Update
January 2 2024
Active Locations (4)
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1
Clinical Trial Site #4
Clearwater, Florida, United States, 33756
2
Endo Clinical Trial Site #2
Coral Gables, Florida, United States, 33146
3
Endo Clinical Trial Site #3
Washington, Missouri, United States, 63090
4
Endo Clinical Trial Site #1
New York, New York, United States, 10065