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

Edematous Fibrosclerotic Panniculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04381117
• Other study ID #: EN3835-220
• Status: Completed
• Start date: May 6, 2020
• Est. completion date: June 22, 2020

Study information

• Verified date: December 2023
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 22, 2020
• Est. primary completion date: June 22, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Edema
• Edematous Fibrosclerotic Panniculopathy

Intervention

Drug:
• Previously Treated with EN3835
No treatment to be administered - Observational only

Locations

Country	Name	City	State
United States	Clinical Trial Site #4	Clearwater	Florida
United States	Endo Clinical Trial Site #2	Coral Gables	Florida
United States	Endo Clinical Trial Site #1	New York	New York
United States	Endo Clinical Trial Site #3	Washington	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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