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

NCT ID: NCT05730335

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-07
• Study Completion Date: 2024-07-17

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rapid Acoustic Pulse (RAP)

Participants will receive 2 separate RAP cellulite treatments sessions.

Group Type: EXPERIMENTAL

Rapid Acoustic Pulse

Intervention Type: DEVICE

Transdermal Rapid Acoustic Pulse Treatments

Interventions

Rapid Acoustic Pulse

Transdermal Rapid Acoustic Pulse Treatments

Intervention Type: DEVICE

Other Intervention Names

RAP

Eligibility Criteria

Inclusion Criteria

• Participants seeking treatment of cellulite in the thigh and/or buttock areas.
• Areas of moderate to severe cellulite on bilateral thigh and/or buttock using the Cellulite Dimple - At Rest Scale at Baseline with grades of 2 or 3 based on review of photos taken under the same lightening conditions planned for the trial.
• Participant will not have had invasive or energy-based cellulite (liposuction, subcision, RF, laser, ESWT, cryo-lipolysis, muscle stimulation, etc.) treatments in the treatment areas in the prior 12 months.
• Participant will not have used topical based cellulite treatments for prior 3 months and will not use during the trial
• Participant will not have used spray-on tanning treatments for 3 months prior to or during the term of the trial.

Exclusion Criteria

• Metal or plastic implants (vascular stent, or implants in the hips, knees, etc.) in the treatment areas.
• Active electronic implants such as pacemakers, defibrillators
• History of coagulopathy and/or on anticoagulant medication
• Skin disorders (skin infections or rashes, psoriasis, etc.) in the treatment areas.
• Medical disorder that would hinder wound healing or immune response.
• Any surgical procedure in the treatment areas in the prior 3 months or planned during the duration of the study.
• Any other condition/disease/situation which, as deemed by the PI, would preclude participant from safely participating in or completing the study visits or that may confound study results.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zeltiq Aesthetics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zeltiq Aesthetics

Role: STUDY_DIRECTOR

Zeltiq Aesthetics

Locations

Chicago Cosmetic Surgery and Dermatology

Chicago, Illinois, United States

Skin and Laser Surgery Center of New England

Nashua, New Hampshire, United States

Union Derm

New York, New York, United States

Bellaire Dermatology

Bellaire, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

M24-262

Identifier Type: -

Identifier Source: org_study_id