NCT05664581

A Study to Assess the Adverse Events and Effectiveness of Rapid Acoustic Pulse (RAP) Device for the Appearance of Cellulite in Adult Participants

Completed Phase 4 Results posted Last updated 18 July 2025

What this trial tests

Phase 4 trial testing Rapid Acoustic Pulse in Cellulite in 14 participants. Completed in 26 July 2024.

Timeline

14 December 2022

Primary endpoint
26 July 2024

26 July 2024

Quick facts

Lead sponsor	Zeltiq Aesthetics
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	14 December 2022
Primary completion	26 July 2024
Estimated completion	26 July 2024
Sites	1 location across United States

Drugs / interventions tested

• Rapid Acoustic Pulse

Conditions studied

• Cellulite — all drugs for Cellulite →

Sponsor

Zeltiq Aesthetics — full company profile →

Who can join

Adults 18 to 50, female only, with Cellulite. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel Primary · Baseline, 12 weeks post-final treatment

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 out of 3 blinded independent reviewers.

Group	Value	95% CI
All Participants	71.4	41.9 – 91.6

Number of Participants With Device-related or Treatment-related: Adverse Events (AEs), Serious AEs (SAEs), Adverse Device Events (ADEs), Serious ADEs (SADEs), Unanticipated AEs or Unanticipated ADEs Primary · Week 1 up to 52 weeks post-final treatment

An adverse event (AE) was defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the participant to have occurred, or a worsening of a pre-existing condition. A SAE resulted in death, was life threatening, required hospitalization, was a persistent or significant disability/incapacity, a birth defect, or was an event that required medical intervention. An ADE was defined as any AE with a reasonable possibility (definitely, probably, possibly, or remotely related) that the event may have been caused by the study device only.

AEs

Group	Value	95% CI
All Participants	2

SAEs

Group	Value	95% CI
All Participants	0

ADEs

Group	Value	95% CI
All Participants	2

SADEs

Group	Value	95% CI
All Participants	0

Unanticipated AEs

Group	Value	95% CI
All Participants	2

Unanticipated ADEs

Group	Value	95% CI
All Participants	0

Number of Participants With "Agree" or "Strongly Agree" Responses to the Participant Satisfaction Survey in the Improvement in Appearance of Cellulite Secondary · Baseline, 12 weeks post-final treatment

The study participant responded to the Participant Satisfaction Survey statement, "In comparison to the pre-treatment photo, the 12 week photograph of the treatment area appears improved." Response choices to this statement were "Strongly Agree", "Agree", "Neutral", "Disagree", and "Strongly Disagree", with "Strongly Agree" representing the greatest perceived improvement in the appearance of cellulite. Reported here is the number of participants who responded with "Agree" or "Strongly Agree." Data are reported for response to photographs on the left and right side of the body.

Group	Value	95% CI
All Participants	5

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality and adverse event tables include events reported from first treatment up to 52 weeks post-final treatment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

All Participants

Serious: 0/14 (0%)

Deaths: 0/14

Other adverse events (2 terms — click to expand)

Reaction	System	All Participants
Application Site Discoloration	General disorders	—
Blister	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT05664581 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.