Study to Evaluate the Safety and Effectiveness of the RAP Device for the Improvement in the Appearance of Cellulite

NCT05199506 | Completed FDA Device

• 1 other identifier: 2021-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this single site clinical study is to evaluate the safety and effectiveness of the Soliton Rapid Acoustic Pulse (RAP) device for the improvement of cellulite comparing two different RAP treatment doses.

Conditions

Cellulite

Outcome Measures

Primary Outcomes (3)

• Assessing safety

  The primary safety short-term endpoint to be met if all treated participants were free from unexpected adverse events (UAEs) or serious adverse events (SAEs) attributable to the RAP treatment immediately post-treatment

  Immediately post treatment

• Assessing safety

  The primary safety short-term endpoint to be met if all treated participants were free from unexpected adverse events (UAEs) or serious adverse events (SAEs) attributable to the RAP treatment at the short-term (12-week) visit.

  12 weeks post treatment

• Assessing Efficacy

  The primary effectiveness objective was to demonstrate improvement in the appearance of cellulite from the 100 Hz treatment is comparable to the 50 Hz treatment. Efficacy determined by the results of a blinded independent physician assessment (IPA) panel correctly identifying the 12-week post-treatment photographs from randomly placed side-by-side comparison of before and after photographs for both treatments. The primary effectiveness endpoint will be met if the rate of correctly identified before and after photos for 100 Hz treatment is not significantly lower than the 50 Hz treatment assessment.

  At 12 week follow up visit

Secondary Outcomes (1)

• Assessing Participant Satisfaction

  At the 12 week follow up visit

Study Arms (1)

Each leg/buttock will be treated with the RAP device

EXPERIMENTAL

Each leg will be treated with standard RAP treatment settings.One leg will receive treatments with 100Hz and the other with 50hz

Device: RAP

Interventions

RAP DEVICE

Treatment of cellulite with RAP device

Each leg/buttock will be treated with the RAP device

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Seeking treatment of cellulite in the thigh and/or buttock areas
• Area of moderate to severe cellulite on thigh and/or buttock for both legs 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.
• Body Mass Index (B.M.I.) is ≤ 30
• Participant will not have had invasive or energy-based cellulite treatments (liposuction, subcision, RF, laser, ESWT, etc.) for the prior 12 months.
• Participant will not have used topical based cellulite treatments for prior 6 months and will not use during the trial.
• Participant will not have used spray-on tanning treatments for 6 months prior to the initiation of the trial. Furthermore, participants will not use spray-on tanning treatments during the term of the trial.
• Participants must be able to provide written informed consent, understand and is willing to comply with all study related procedures and follow-up visits.

You may not qualify if:

• Participant is unwilling to have research photos taken of treatment areas in the presence of Sponsor's researchers.
• Participant is unwilling to have RAP treatment provided in the presence of Sponsor's researchers.
• Participant is pregnant or planning to become pregnant during the duration of the study.
• Participant is unwilling to commit to follow-up visits
• Metal or plastic implants in the area of the treatment (vascular stent, or implants in the hips, knees, etc.).
• Active electronic implants such as pacemakers, defibrillators.
• History of coagulopathy(ies) and/or on anticoagulant medication.
• Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
• Any surgical procedure in the treatment areas in the prior 3 months or planned during the duration of the study.
• Participant is a current smoker.
• Participant has tattoo in treatment area.

Sponsors & Collaborators

• Soliton: lead

Study Sites (1)

The Practice of Brian Biesman

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• Biesman BS, Capelli CC. Comparing safety and efficacy of acoustic subcision at two different rapid acoustic pulse rates to improve the appearance of cellulite. Lasers Surg Med. 2024 Jan;56(1):32-38. doi: 10.1002/lsm.23718. Epub 2023 Sep 11.

  PMID: 37694399 DERIVED

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chris Capelli, MD

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: January 20, 2022
• Study Start: May 4, 2021
• Primary Completion: October 21, 2021
• Study Completion: July 28, 2022
• Last Updated: May 3, 2023

Record last verified: 2023-05

Locations

US (1)