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

NCT04381117 | Completed FDA Drug

• 1 other identifier: EN3835-220
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 4

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.

Conditions

Edematous Fibrosclerotic Panniculopathy

Keywords

EFP; Cellulite

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

Previously Treated with EN3835 DRUG

No treatment to be administered - Observational only

No Treatment

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (4)

Clinical Trial Site #4

Clearwater, Florida, 33756, United States

Location

Endo Clinical Trial Site #2

Coral Gables, Florida, 33146, United States

Location

Endo Clinical Trial Site #3

Washington, Missouri, 63090, United States

Location

Endo Clinical Trial Site #1

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Chajko

  Endo Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 8, 2020
• Study Start: May 6, 2020
• Primary Completion: June 22, 2020
• Study Completion: June 22, 2020
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (4)