This is a multicenter, open-label, multiple dose, 2 cohort, Phase 3b study to assess the safety and efficacy of CCH in adult women with mild or moderate edematous fibrosclerotic panniculopathy (EFP). Cohort 1 will include approximately 80 subjects with mild or moderate EFP in the posterolateral thighs and Cohort 2 will include approximately 70 subjects with mild or moderate EFP in the buttocks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
153
Collagenase Clostridium Histolyticum (CCH)
Endo Clinical Trial Site #2
Encino, California, United States
Endo Clinical Trial Site #4
San Diego, California, United States
Endo Clinical Trial Site #5
Solana Beach, California, United States
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
Time frame: 90 Days
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
Time frame: 90 Days
Mean Change From Baseline in CR-PCSS for Each Buttock
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (none) to "4" (severe) from a clinician's perspective.
Time frame: Day 22, 43, 90 and 180
Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score
The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center
Time frame: Day 90, Day 180
Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score
The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center
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Endo Clinical Trial Site #9
Westport, Connecticut, United States
Endo Clinical Trial Site #1
Coral Gables, Florida, United States
Endo Clinical Trial Site #10
Alpharetta, Georgia, United States
Endo Clinical Trial Site #3
Chicago, Illinois, United States
Endo Clinical Trial Site #11
Itasca, Illinois, United States
Endo Clinical Trial Site #8
New Orleans, Louisiana, United States
Endo Clinical Trial Site #6
New York, New York, United States
...and 2 more locations
Time frame: Day 90, Day 180
The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
Time frame: Day 22, 43, and 180
The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
Time frame: Day 22, 43, and 180
Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh)
Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses
Time frame: Day 1, 90, and 180
Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks)
Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses
Time frame: Day 1, 90 and 180
Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh)
All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb.
Time frame: Day 1, 90 and 180
Presence of NAb Anti AUX-I and AUX-II (Buttocks)
All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb.
Time frame: Day 1, 90 and 180