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

Endo Pharmaceuticals20 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Cellulite Laxity; Skin Edematous Fibrosclerotic Panniculopathy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (3)

Endo Clinical Trial Site #2

Coral Gables, Florida, United States

Endo Clinical Trial Site #3

Metairie, Louisiana, United States

Endo Clinical Trial Site #1

New York, New York, United States

Outcomes

Primary Outcomes

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

Time frame: Day 360

Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh

Time frame: Day 540

Secondary Outcomes

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.

Time frame: 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).

Time frame: 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).

Time frame: Day 360 and Day 540

Data from ClinicalTrials.gov

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