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

A Multi-Center, Prospective Study to Evaluate the Safety and Effectiveness of Multi-Treatment Regimen With Zeltiq Aesthetics, Inc. Rapid Acoustic Pulse (RAP)™ Device for the Improvement in the Appearance of Cellulite

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cellulite
• Intervention / Treatment: Device: Rapid Acoustic Pulse

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Chicago Cosmetic Surgery and Dermatology
  • New Hampshire
    • Nashua, New Hampshire, United States, 03060
      • Skin and Laser Surgery Center of New England
  • New York
    • New York, New York, United States, 10003
      • Union Derm
  • Texas
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rapid Acoustic Pulse (RAP); Participants will receive 2 separate RAP cellulite treatments sessions.	Device: Rapid Acoustic Pulse; Transdermal Rapid Acoustic Pulse Treatments; Other Names: RAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Improvement in the Appearance of Cellulite as Determined by Blinded Independent Physician Reviewers (IPR)	The number of before and after side-by-side photographs correctly identified by at least 2 of 3 blinded reviewers from the IPR panel.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with "Agree" or "Strongly Agree" Responses to the Participant Satisfaction Survey in the Improvement in Appearance of Cellulite	The study participant demonstrates improvement by selecting ''Agree" or "Strongly Agree" as answers to the Participant Satisfaction Survey statement - 'In comparison to the pre-treatment photo, the 12 week photograph of the treatment area appears improved.'	Week 16
Number of Participants with Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered by a medical device which does not necessarily have a causal relationship with the treatment.	60 Weeks

Collaborators and Investigators

• Sponsor: Zeltiq Aesthetics
• Investigators: Study Director: Zeltiq Aesthetics, Zeltiq Aesthetics

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Actual): November 3, 2023
• Study Completion (Estimated): July 14, 2024

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: RAP; Cellulite; Rapid Acoustic Pulse
• Additional Relevant MeSH Terms: Skin Manifestations; Cellulite
• Other Study ID Numbers: M24-262

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes