Long-term Durability Study of Collagenase Clostridium Histolyticum (CCH)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04381117 |
Recruitment Status :
Completed
First Posted : May 8, 2020
Last Update Posted : August 6, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Edematous Fibrosclerotic Panniculopathy | Drug: Previously Treated with EN3835 |
Study Type : | Observational |
Actual Enrollment : | 7 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | A Phase 2b, Open-label Long-term Durability Study of CCH Following Treatment of Edematous Fibrosclerotic Panniculopathy (Cellulite) |
Actual Study Start Date : | May 6, 2020 |
Actual Primary Completion Date : | June 22, 2020 |
Actual Study Completion Date : | June 22, 2020 |
Group/Cohort | Intervention/treatment |
---|---|
No Treatment
Subjects who participated in and completed study EN3835-201 and had composite improvement of at least 2-levels on both the Clinician Reported-Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported-Photonumeric Cellulite Severity Scale (PR-PCSS) in EN3835-201 study will be eligible for this study. The study will consist of a single day evaluation approximately 4 years after the first dose of the study drug was received in the EN3835-201 study.
|
Drug: Previously Treated with EN3835
No treatment to be administered - Observational only |
- CR-PCSS change from baseline (Day 1) and reference time point (Day 71) from the EN3835-201 study [ Time Frame: Approximately 4 weeks ]Clinician Reported-Photonumeric Cellulite Severity Scale is a 5-level photonumeric scale with ratings ranging from 0 (None) to 4 (Severe)
- PR-PCSS change from baseline (Day 1) and reference time point (Day 71) from the EN3835-201 study [ Time Frame: Approximately 4 weeks ]Patient Reported-Photonumeric Cellulite Severity Scale is a 5-level photonumeric scale with ratings ranging from 0 (None) to 4 (Severe)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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 Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04381117
United States, Florida | |
Clinical Trial Site #4 | |
Clearwater, Florida, United States, 33756 | |
Endo Clinical Trial Site #2 | |
Coral Gables, Florida, United States, 33146 | |
United States, Missouri | |
Endo Clinical Trial Site #3 | |
Washington, Missouri, United States, 63090 | |
United States, New York | |
Endo Clinical Trial Site #1 | |
New York, New York, United States, 10065 |
Study Director: | Karen Chajko | Endo Pharmaceuticals |
Responsible Party: | Endo Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT04381117 |
Other Study ID Numbers: |
EN3835-220 |
First Posted: | May 8, 2020 Key Record Dates |
Last Update Posted: | August 6, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
EFP Cellulite |
Edema |