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NCT05664581 · ClinicalTrials.gov registry record · Phase 4
A Study to Assess the Adverse Events and Effectiveness of Rapid Acoustic Pulse (RAP) Device for the Appearance of Cellulite in Adult Participants
A Phase 4 study, sponsored by Zeltiq Aesthetics.
- Completed
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
NCT05664581: Completed Phase 4 study, sponsored by Zeltiq Aesthetics.
NCT05664581 is a Phase 4 study that has completed, run by Zeltiq Aesthetics. The registered enrollment target is 14 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05664581, a Phase 4 study, has completed, sponsored by Zeltiq Aesthetics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
Study Summary
Cellulite is the rippling or dimpling of the skin most commonly located on the thighs and buttocks of women. Its appearance and texture are often likened to that of "cottage cheese" or an orange peel. Rapid Acoustic Pulse (RAP) is an electrohydraulic (EH) device developed to improve the appearance of cellulite through microscopic disruption of the connection between the skin and underlying tissue leading to a reduction in the severity of dimples and ridges. The purpose of this study is to assess adverse events and effectiveness of RAP in adults seeking treatment of cellulite. RAP is an FDA approved device for the short-term improvement in the appearance of cellulite in the buttocks and thighs. Participants 18-50 years of age seeking treatment of cellulite will be enrolled. Up to 15 participants will be enrolled in the study at 1 site in the United States. Participants will receive 3 separate cellulite treatment sessions. Each treatment session will consist of RAP treatment delivered to bilateral thigh and/or buttock areas using the same treatment settings for both sides. The study duration is up to 72 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Primary Outcome
Photographs of the treatment areas were taken at baseline, and at 12-weeks after post-final treatment to determine if the RAP treatment had the effect of improvement in the appearance of cellulite. The photographs were assessed by blinded independent reviewers (IPR) to correctly identify the 12-weeks post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. Reported here is the percentage (%) of images that were correctly identified by at least 2 ou
Interventions
- DEVICE Rapid Acoustic Pulse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2022-12-14 |
| Est. Completion | 2024-07-26 |
| Phase | Phase 4 |
What the finished NCT05664581 record still lists
NCT05664581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Rapid Acoustic Pulse is the first listed.
NCT05664581 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05664581 about?
NCT05664581 is a clinical study titled "A Study to Assess the Adverse Events and Effectiveness of Rapid Acoustic Pulse (RAP) Device for the Appearance of Cellulite in Adult Participants". Cellulite is the rippling or dimpling of the skin most commonly located on the thighs and buttocks of women. Its appearance and texture are often likened to that of "cottage cheese" or an orange peel. Rapid Acoustic Pulse (RAP) is an electrohydraulic (EH) device developed to improve the appearance o...
What is the current status of trial NCT05664581?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2022-12-14. Estimated completion is 2024-07-26.
What interventions are being tested in trial NCT05664581?
The interventions under investigation include: Rapid Acoustic Pulse (DEVICE).
Who is sponsoring clinical trial NCT05664581?
This trial is sponsored by Zeltiq Aesthetics, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05664581's enrollment target sits among peer trials
14 1901st of 2000 higher than 91 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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