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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cellulite, Laxity; Skin, Edematous Fibrosclerotic Panniculopathy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have participated in and completed study EN3835-224 (parent study). Be willing and able to cooperate with the requirements of the study. Exclusion Criteria: Has received any collagenase treatments (eg, Santyl® Ointment) at any time since 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. Has any other conditions that, in the investigator's opinion, might indicate the participant to be unsuitable for the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Treatment - previously treated in parent study<br>Participants who completed the parent study EN3835-224 (NCT04580303) will be eligible for this study. | |

What is the study measuring?
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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 |