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

NCT05730335 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2025-06-24

Study results available
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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 long-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 60 participants will be enrolled in the study at 4 sites in the United States.

Participants will receive 2 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 60 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.

Conditions

  • Cellulite

Interventions

DEVICE

Rapid Acoustic Pulse

Transdermal Rapid Acoustic Pulse Treatments

Sponsors & Collaborators

  • Zeltiq Aesthetics

    lead INDUSTRY

Principal Investigators

  • Zeltiq Aesthetics · Zeltiq Aesthetics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-07
Primary Completion
2023-11-03
Completion
2024-07-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05730335 on ClinicalTrials.gov