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

A Phase 2, Multicenter, Observational Study to Assess the Durability and Safety of Collagenase Clostridium Histolyticum Injected With GRID Technique in Buttocks or Thigh Cellulite With Laxity in Adult Females

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Endo Clinical Trial Site #2
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Endo Clinical Trial Site #3
  • New York
    • New York, New York, United States, 10021
      • Endo Clinical Trial Site #1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The Safety Population is defined as all participants who meet the inclusion/exclusion criteria at Day 360. All Safety analyses will be based on this population.

The Full Analysis Set (FAS) is defined as all participants in the Safety Population who have at least 1 I-GAIS assessment. All efficacy analyses will be based on this population.

Description

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 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
No Treatment - previously treated in parent study; Participants who completed the parent study EN3835-224 (NCT04580303) will be eligible for this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh	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	Day 360
Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh	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	Day 540

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
I-GAIS ratings	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.	Day 360 and Day 540
Proportion of 1-level responders (+1 or better score) on the S-GAIS for either buttock or either thigh	Subject Global Aesthetic Improvement Scale (S-GAIS) is a 7-level scale ranging from "+3" (very much improved) to a "-3" (very much worse).	Day 360 and Day 540
Change from Day 1 (pre-treatment) of the parent study and each study visit in Subsection D of the Hexsel CSS	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).	Day 360 and Day 540

Collaborators and Investigators

• Sponsor: Endo Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2022
• Primary Completion (Actual): September 12, 2022
• Study Completion (Actual): September 12, 2022

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations; Cellulite
• Other Study ID Numbers: EN3835-225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No