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

NCT ID: NCT05199506

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-04
• Study Completion Date: 2022-07-28

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.

Detailed Description

This is a non-significant risk, single-center, prospective trial for safety, and efficacy using Soliton's RAP device for the improvement in the appearance of cellulite performed at 1 (one) clinical research site in the United States.

Approximately 15 healthy female participants between the age of 18-55 inclusive will be enrolled in this study.

Participants who sign the informed consent form and meet all the eligible criteria will be enrolled in the study. Each participant will undergo acoustic rapid pulse (RAP) treatments on each of the participants buttocks and legs. The participant's right buttock and leg will receive 100 Hz doses, and the participants left buttock and leg will receive 50 Hz doses.

Total study duration is anticipated to be at or less than 55 weeks from the first participant visit to the last participant observation visit. A total of 3 visits, plus two optional visits are planned for this study as listed below:

• Visit 1: Baseline/Screening (-30 Days to Day 0)
• Visit 2: Treatment (Day 0)
• Visit 3: 12-week Follow-Up Visit (+/- 14 Days)
• Visit 4: 26-week Follow-Up Visit (+/- 14 Days) (Optional)
• Visit 5: 52 Week Follow-Up Visit (+/- 14 Days) (Optional)

Conditions

Cellulite

Study Design

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

Study Groups

Each leg/buttock will be treated with the RAP device

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

Group Type: EXPERIMENTAL

RAP

Intervention Type: DEVICE

Treatment of cellulite with RAP device

Interventions

RAP

Treatment of cellulite with RAP device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Soliton

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chris Capelli, MD

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

The Practice of Brian Biesman

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37694399 (View on PubMed)

Other Identifiers

2021-02

Identifier Type: -

Identifier Source: org_study_id