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

Endo Pharmaceuticals7 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Edematous Fibrosclerotic Panniculopathy

Interventions

Previously Treated with EN3835DRUG

No treatment to be administered - Observational only

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. Be willing and able to cooperate with the requirements of the study. Exclusion Criteria: 1. Has had retreatment with CCH in the area initially treated during the EN3835-201 study since the completion of study EN3835-219. 2. Has received collagenase treatments (eg, Santyl® Ointment and/or Xiaflex®/Xiapex®) since the completion of study EN3835-219. 3. Has had liposuction on the body region treated during the EN3835-201 study since the completion of that study. 4. 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. 5. Has any other condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.

Locations (4)

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

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: Approximately 4 weeks

Data from ClinicalTrials.gov

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