Long-term Durability Study of Collagenase Clostridium Histolyticum (CCH)

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2b, Open-label Long-term Durability Study of CCH Following Treatment of Edematous Fibrosclerotic Panniculopathy (Cellulite)

Conditions
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Edematous Fibrosclerotic Panniculopathy

Intervention / Treatment
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* Drug: Previously Treated with EN3835


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Treatment<br>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<br>* No treatment to be administered - Observational only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CR-PCSS change from baseline (Day 1) and reference time point (Day 71) from the EN3835-201 study | Clinician Reported-Photonumeric Cellulite Severity Scale is a 5-level photonumeric scale with ratings ranging from 0 (None) to 4 (Severe) | Approximately 4 weeks | 
| PR-PCSS change from baseline (Day 1) and reference time point (Day 71) from the EN3835-201 study | Patient Reported-Photonumeric Cellulite Severity Scale is a 5-level photonumeric scale with ratings ranging from 0 (None) to 4 (Severe) | Approximately 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EFP, Cellulite