The study will evaluate the effect of different doses, strengths (concentrations), diluent additives, depths of injection, and methods of injection on the severity of bruising potentially induced by QWO (collagenase clostridium histolyticum-aaes \[CCH-aaes\]).
The study will comprise a Screening Period (28 days), Treatment Period (90 days), and Follow-up Period (90 days). Participants will receive CCH-aaes in different doses, concentrations, diluent additives, depths of injection, and methods of injection in a split buttock arrangement, with the right buttock serving as the control, and the left buttock (investigational side) receiving a study intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
91
Administered by subcutaneous injection.
Self-administered by participants enrolled in Cohort 7.
Endo Clinical Trial Site #6
Scottsdale, Arizona, United States
Endo Clinical Trial Site #4
Beverly Hills, California, United States
Endo Clinical Trial Site #9
Encinitas, California, United States
Percentage of Participants With at Least 1-Level Lower Score 3 to 5 Days After Initial CCH-aaes Injection, as Assessed by the Investigator Assessment of Bruising Severity Scale (IABSS) After Initial CCH-aaes Injection
The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcomes. The investigator compared the bruising of the left (test) buttock to the right (control) buttock. Responders were participants whose left buttock/test side demonstrated at least a 1-level lower IABSS score versus the right buttock/control side. Percentages are based on the number of participants with an assessment at specified timepoint.
Time frame: 3 to 5 days after initial CCH-aaes injection of left buttock (test) and right buttock (control)
Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS
The investigator assessed the severity of bruising using the IABSS, The IABSS is a 5-point scale ranging from 0-4, with 0 indicating no bruising or almost none, and 4 indicating very severe bruising. Higher scores indicated worse outcome. The investigator compared the bruising of the left buttock (test) to the right (control) buttock. Responders were participants whose left buttock/test side at Visit A demonstrated at least a 1-level lower IABSS score versus the right buttock/control side at Visit B, where Visit A and B could either be the same or different. Follow-up after first injection is presented: Follow-up 1 is 1 to 2 days after injection visit, Follow-up 2 is 3 to 5 days after injection visit, Follow-up 3 is 6 to 9 days after injection visit, and Follow-up 4 is 10 to 14 days after injection visit. Percentages are based on the number of participants with an assessment at specified timepoint.
Time frame: Follow-up 1, 2, 3, and 4 after CCH-aaes injection of left buttock (test) and right buttock (control)
Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection
The investigator determined the degree of improvement of each buttock by comparing treated cellulite dimples from the Day 1 pre-treatment (Baseline) digital image of each buttock to the treated dimples observed in a live assessment. The investigator determined the degree of improvement of each buttock with the I-GAIS, which uses a 7-point scale ranging from +3 (very much improved) to -3 (very much worse). A higher score indicated a better outcome. The investigator compared the bruising of the left (test) buttock to the right (control) buttock. A 1-level I-GAIS responder was defined as any participant with an improved (+1, +2 or +3) score on the I-GAIS at an analysis visit for that treatment area. Percentages are based on the number of participants with an assessment at specified timepoint.
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Endo Clinical Trial Site #10
San Diego, California, United States
Endo Clinical Trial Site #7
Solana Beach, California, United States
Endo Clinical Trial Site #12
Greenwood Village, Colorado, United States
Endo Clinical Trial Site #8
Coral Gables, Florida, United States
Endo Clinical Trial Site #13
Miami, Florida, United States
Endo Clinical Trial Site #3
Chicago, Illinois, United States
Endo Clinical Trial Site #2
Metairie, Louisiana, United States
...and 3 more locations
Time frame: Day 22 and Day 43 for Cohorts 1 to 5, Day 43 for Cohort 6, Day 22, Day 43, and Day 64 for Cohort 7, and Day 90, Day 135, and Day 180 for all cohorts
Percentage of Participants With Injection Site Reactions
Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that occur or worsen (increase in severity) on the same day or after the study intervention administration on Day 1. Percent of participants with TEAEs of injection site reactions are presented by left buttock (test) and right buttock (control). A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: From Day 1 (after dose) through Day 180