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NCT05836779 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 2)
A Phase 2 study of Cellulite, sponsored by Caliway Biopharmaceuticals Co..
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 5
- Study locations
NCT05836779: Completed Phase 2 study of Cellulite, sponsored by Caliway Biopharmaceuticals Co..
NCT05836779 is a Phase 2 study of Cellulite that has completed, run by Caliway Biopharmaceuticals Co.. The registered enrollment target is 23 participants, below the 168-participant average among 5 other Cellulite trials with a reported enrollment target (86% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05836779, a Phase 2 study of Cellulite, has completed, sponsored by Caliway Biopharmaceuticals Co..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
- 5
- Study locations
Study Summary
The Stage 2 of this phase 2 study is an open-label, single-arm study to assess the efficacy and safety of CBL-514 in participants with Edematous Fibrosclerotic Panniculopathy (EFP) cellulite.
Primary Outcome
Change in total scores from baseline in the Modified Hexsel Cellulite Severity Scale to 4 weeks after the final treatment. The Modified Hexsel Cellulite Severity Scale is based on (A) number of evident depressions, (B) depression depth scale, and (C) morphological appearance of skin surface alterations.
Conditions Studied
Interventions
- DRUG CBL-514 injection
Study Locations (5)
California
- Investigational Site 6 - Encinitas
- Investigational Site 1 - Encino
- Investigational Site 3 - San Diego
Florida
- Investigational Site 4 - Coral Gables
New York
- Investigational Site 2 - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2023-05-10 |
| Est. Completion | 2024-01-05 |
| Phase | Phase 2 |
What the finished NCT05836779 record still lists
NCT05836779 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 168-participant average among 5 other Cellulite trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Cellulite appearing as the primary indexed condition, and to 1 intervention - of which CBL-514 injection is the first listed.
NCT05836779 lists 5 locations in 3 states (California, Florida, New York).
Frequently Asked Questions
What is clinical trial NCT05836779 about?
NCT05836779 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 2)". The Stage 2 of this phase 2 study is an open-label, single-arm study to assess the efficacy and safety of CBL-514 in participants with Edematous Fibrosclerotic Panniculopathy (EFP) cellulite.
What is the current status of trial NCT05836779?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2023-05-10. Estimated completion is 2024-01-05.
What conditions does trial NCT05836779 study?
This clinical trial studies the following conditions: Cellulite.
What interventions are being tested in trial NCT05836779?
The interventions under investigation include: CBL-514 injection (DRUG).
Who is sponsoring clinical trial NCT05836779?
This trial is sponsored by Caliway Biopharmaceuticals Co., which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05836779 being conducted?
This trial has 5 study locations across California, Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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