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

Completed

• Conditions: Edematous Fibrosclerotic Panniculopathy
• Interventions: Drug: Previously Treated with EN3835

• Registration Number: NCT04381117
• Lead Sponsor: Endo Pharmaceuticals

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 first dose of study drug was received in the EN3835-201.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-06
• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-08
• Primary Completion: 2020-06-22
• Study Completion: 2020-06-22
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-29
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No Treatment	Previously Treated with EN3835	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.

Primary Outcome Measures

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

Trial Locations

Locations (4)

Endo Clinical Trial Site #1; 🇺🇸 New York, New York, United States

Endo Clinical Trial Site #3; 🇺🇸 Washington, Missouri, United States

Clinical Trial Site #4; 🇺🇸 Clearwater, Florida, United States

Endo Clinical Trial Site #2; 🇺🇸 Coral Gables, Florida, United States