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NCT05419505 · ClinicalTrials.gov registry record · Phase 2
Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks
A Phase 2 study of Cellulite and Edematous Fibrosclerotic Panniculopathy, sponsored by Endo Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
- 13
- Study locations
NCT05419505: Completed Phase 2 study of Cellulite and Edematous Fibrosclerotic Panniculopathy, sponsored by Endo Pharmaceuticals.
NCT05419505 is a Phase 2 study of Cellulite and Edematous Fibrosclerotic Panniculopathy that has completed, run by Endo Pharmaceuticals. The registered enrollment target is 91 participants, below the 154-participant average among 5 other Cellulite trials with a reported enrollment target (41% lower). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05419505, a Phase 2 study of Cellulite and Edematous Fibrosclerotic Panniculopathy, has completed, sponsored by Endo Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
- 13
- Study locations
Study 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 \[CCH-aaes\]).
Primary Outcome
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 a
Conditions Studied
Interventions
- DRUG CCH-aaes
- DRUG Antifibrinolytic Agent
Study Locations (13)
California
- Endo Clinical Trial Site #4 - Beverly Hills
- Endo Clinical Trial Site #9 - Encinitas
- Endo Clinical Trial Site #10 - San Diego
- Endo Clinical Trial Site #7 - Solana Beach
Florida
- Endo Clinical Trial Site #8 - Coral Gables
- Endo Clinical Trial Site #13 - Miami
Arizona
- Endo Clinical Trial Site #6 - Scottsdale
Colorado
- Endo Clinical Trial Site #12 - Greenwood Village
Illinois
- Endo Clinical Trial Site #3 - Chicago
Louisiana
- Endo Clinical Trial Site #2 - Metairie
New York
- Endo Clinical Trial Site #11 - New York
Tennessee
- Endo Clinical Trial Site #1 - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2022-06-15 |
| Est. Completion | 2023-06-21 |
| Phase | Phase 2 |
What the finished NCT05419505 record still lists
NCT05419505 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 154-participant average among 5 other Cellulite trials with a reported enrollment target (41% lower).
The record links to 2 conditions, with Cellulite appearing as the primary indexed condition, and to 2 interventions - of which CCH-aaes is the first listed.
NCT05419505 lists 13 locations in 9 states (California, Florida, Arizona).
Frequently Asked Questions
What is clinical trial NCT05419505 about?
NCT05419505 is a clinical study titled "Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks". 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 \[CCH-aaes\]).
What is the current status of trial NCT05419505?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2022-06-15. Estimated completion is 2023-06-21.
What conditions does trial NCT05419505 study?
This clinical trial studies the following conditions: Cellulite, Edematous Fibrosclerotic Panniculopathy.
What interventions are being tested in trial NCT05419505?
The interventions under investigation include: CCH-aaes (DRUG), Antifibrinolytic Agent (DRUG).
Who is sponsoring clinical trial NCT05419505?
This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05419505 being conducted?
This trial has 13 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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