Phase 2
N=91
Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks
Edematous Fibrosclerotic Panniculopathy · Cellulite
Bottom Line
View on ClinicalTrials.gov: NCT05419505 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: 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 — 90.5; 25.0; 20.0; 33.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CCH-aaes (Drug); Antifibrinolytic Agent (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Endo Pharmaceuticals
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
90.5; 25.0; 20.0; 33.3; 44.4; 63.2 | — |
| SECONDARY Percentage of Participants With at Least 1-Level Lower Score, as Assessed by the IABSS |
81.8; 15.4; 0; 42.9; 40.0; 44.4 | — |
| SECONDARY Percentage of Participants With at Least +1 or Higher Score on the Investigator-Global Aesthetic Improvement Scale (I-GAIS) After CCH-aaes Injection |
42.9; 58.3; 100; 66.7; 40.0; 85.7 | — |
| SECONDARY Percentage of Participants With Injection Site Reactions |
100; 92.9; 100; 100; 100; 100 | — |
Summary
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]).
Eligibility Criteria
Key Inclusion Criteria
- Have a body mass index of 18 to 1.4 milligram/deciliter at Screening.
- Requires the following concomitant medications during the study and cannot discontinue these medications within the time specified before CCH-aaes treatment:
- concurrently taking combination hormonal contraceptives.
- concurrently undergoing hormone replacement therapy.
- is a current smoker of nicotine or cannabinoids.
- Participants in Cohort 7 should avoid smoking (including vaping, nicotine, or marijuana cigarettes) during the study.
Data sourced from ClinicalTrials.gov (NCT05419505). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.