This study is designed to investigate the safety and efficacy of collagenase clostridium histolyticum (CCH) for the treatment of mild to moderate edematous fibrosclerotic panniculopathy (cellulite) in participants with moderate to severe dermal laxity in the buttocks or thighs with comparison between two (2) different CCH injection techniques.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Delivered via uniform grid injection techniques.
Endo Clinical Trial Site #3
Coral Gables, Florida, United States
Endo Clinical Trial Site #2
Metairie, Louisiana, United States
Endo Clinical Trial Site #1
New York, New York, United States
Percentage of 1-Level Responders (+1 or Better Score) on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) for Either Buttock or Either Thigh
I-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level I-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented.
Time frame: Day 180
Percentage of 1-Level Responders (+1 or Better Score) on the I-GAIS for Either Buttock or Either Thigh
I-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level I-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented.
Time frame: Days 28, 56, 84, 112, and 140
Percentage of 1-Level Responders (+1 or Better Score) on the Subject Global Aesthetic Improvement Scale (S-GAIS) for Either Buttock or Either Thigh
S-GAIS assessments were based on digital photographs, and were performed separately for each of 2 treatment areas. S-GAIS is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the participant ranging from "Very Much Worse" (-3), "Much Worse" (-2), "Worse" (-1), "No Change" (0), "Improved" (+1), "Much Improved" (+2), and "Very Much Improved" (+3). One-level S-GAIS Responder for a treatment area (left buttock, right buttock, left thigh, or right thigh) was defined as any participant with an improved (+1, +2 or +3) score on the S-GAIS at the analysis visit for that treatment area. The percentage of participants who were 1-level responders for either buttock (right or left) or either thigh (right or left) is presented.
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Time frame: Days 28, 56, 84, 112, 140, and 180
Change From Baseline in Body-Q Appraisal of Cellulite Total Score
The Body-Q Appraisal of Cellulite is a subset of 11 questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. Total score is the sum of all 11 question scores. The minimum possible total score is 11 and the maximum possible total score is 44. Higher scores indicate the individual is less bothered by their cellulite.
Time frame: Baseline, Day 180
Change From Baseline in Hexsel Cellulite Severity Scale (CSS) Subsection D Severity Score
Hexsel CSS is a photonumeric scale that looks at 5 key morphologic features of cellulite using a 4-point scale from a low of 0 to high of 3: 0 (absence of laxity, flaccidity, or sagging skin), 1 (slight draped appearance), 2 (moderate draped appearance), and 3 (severe draped appearance). The investigator or qualified designee used the Hexsel CSS Subsection D to assess the severity of dermal laxity in each buttock or each thigh independently. A decrease from baseline indicated a better outcome.
Time frame: Baseline, Days 28, 56, 84, 112,140, and 180
Percentage of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies
Blood samples were collected to assess anti-clostridial class I collagenase (AUX-I) and anti-Clostridial class II collagenase (AUX-II) antibody levels. The percentage of participants who were positive for anti-AUX-I and anti-AUX-II antibodies are presented.
Time frame: Day 180
Percentage of Participants Positive for Neutralizing Antibodies to AUX-I and AUX-II
Blood samples were collected to assess neutralizing antibodies to AUX-I and AUX-II. The percentage of participants who were positive for neutralizing antibodies to AUX-I and AUX-II are presented.
Time frame: Day 180