Durability and Safety of CCH With Two Different Injection Techniques in Cellulite With Laxity

Completed

• Conditions: Cellulite; Edematous Fibrosclerotic Panniculopathy; Laxity; Skin

• Registration Number: NCT05249257
• Lead Sponsor: Endo Pharmaceuticals

Brief Summary

All participants who completed the EN3835-224 study will be invited to participate in this observational study to evaluate long term durability of response and safety.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-25
• Study First Submitted: 2022-01-25
• Study First Submitted QC: 2022-02-18
• Study First Posted: 2022-02-21
• Primary Completion: 2022-09-12
• Study Completion: 2022-09-12
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-18
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

1. Have participated in and completed study EN3835-224 (parent study).
2. Be willing and able to cooperate with the requirements of the study.

Exclusion Criteria

1. Has received any collagenase treatments (eg, Santyl® Ointment) at any time since
2. Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment in the area treated during the EN3835-224 study since the completion of that study.
3. Has any other conditions 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

Primary Outcome Measures

Name	Time	Method
Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh	Day 540	Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-level scale ranging from "+3" (very much improved) to "-3" (very much worse) to determine the degree of improvement of the treated areas

Secondary Outcome Measures

Name	Time	Method
Proportion of 1-level responders (+1 or better score) on the S-GAIS for either buttock or either thigh	Day 360 and Day 540	Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-level scale ranging from "+3" (very much improved) to a "-3" (very much worse).
I-GAIS ratings	Day 360 and Day 540	Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-level scale ranging from "+3" (very much improved) to a "-3" (very much worse) to determine the degree of improvement of the treated areas.
Change from Day 1 (pre-treatment) of the parent study and each study visit in Subsection D of the Hexsel CSS	Day 360 and Day 540	Hexsel CSS is a photonumeric scale that looks at 5 key morphologic features of cellulite using a 4-point scale ranging from "0" (low) to "3" (high).

Trial Locations

Locations (3)

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; 🇺🇸 Metairie, Louisiana, United States