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

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

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 Overview

• Status: Completed
• Conditions: Edematous Fibrosclerotic Panniculopathy
• Intervention / Treatment: Drug: Previously Treated with EN3835

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • Florida
    • Clearwater, Florida, United States, 33756
      • Clinical Trial Site #4
    • Coral Gables, Florida, United States, 33146
      • Endo Clinical Trial Site #2
  • Missouri
    • Washington, Missouri, United States, 63090
      • Endo Clinical Trial Site #3
  • New York
    • New York, New York, United States, 10065
      • Endo Clinical Trial Site #1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The Durability Population, defined as all subjects in the Safety Population who have both CR-PCSS and PR-PCSS assessments at Visit 1 (Month 48).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Endo Pharmaceuticals
• Investigators: Study Director: Karen Chajko, Endo Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2020
• Primary Completion (Actual): June 22, 2020
• Study Completion (Actual): June 22, 2020

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 8, 2020

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: EFP; Cellulite
• Additional Relevant MeSH Terms: Edema
• Other Study ID Numbers: EN3835-220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No