Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) for the Treatment of Cellulite

Not Applicable

Completed

• Conditions: Cellulite
• Interventions: Device: Soliton Rapid Acoustic Pulse (RAP)

• Registration Number: NCT03981198
• Lead Sponsor: Soliton

Brief Summary

Feasibility study is to evaluate the safety, tolerability and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the treatment of cellulite

Detailed Description

To assess the safety and tolerability of Soliton's RAP Nov Heavy for the treatment of cellulite. To assess the efficacy of Soliton's RAP Nov Heavy device for the temporary improvement in appearance of cellulite in terms of mean change in cellulite severity score (CSS).

Study Timeline

• Study Start: 2018-07-31
• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-06-07
• Study First Posted: 2019-06-10
• Primary Completion: 2019-08-05
• Study Completion: 2019-08-05
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• Female ages 18-65 years
• Participant seeking treatment of cellulite in the upper lateral thigh areas
• Participant presenting with cellulite Grade I or II on both thighs as graded using the Nurnberger-Muller scale classification (Appendix A)
• Participant has stable weight. Body Mass Index (B.M.I.) is ≤ 30
• Participant will not have any other cellulite treatments for 12 months before and throughout the 3-month follow-up
• Participant is willing to participate in study and adhere to follow-up schedule
• Participant is able to read and comprehend English
• Participant has completed Informed Consent Form

Exclusion Criteria

• Participant is pregnant or planning to become pregnant during the duration of the study
• Participant has a BMI > 30
• Greater than 10% increase or decrease in body weight within past 6 months
• Cellulite treatment on the thighs or buttocks in the last 12 months (Topical or non-invasive procedure)
• 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, cochlear implants, nerve/brain stimulators, drug pump, etc.
• Prior liposuction in the thighs or buttocks or any other invasive procedure to limit cellulite.
• Medical disorder that would hinder the wound healing or immune response (no blood disorder, diabetes, inflammatory disease, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RAP treatment	Soliton Rapid Acoustic Pulse (RAP)	Single RAP treatment applied to thigh and multi-treatment applied to the other thigh.

Primary Outcome Measures

Name	Time	Method
Treatment Tolerability	18 Weeks	The primary endpoint will be met if a mean tolerability measure using pain scores averaged across all treated Participants is \< 8.0
Incidence of SAEs	18 weeks	The primary safety endpoint will be met if all treated Participants are free from serious adverse events (SAEs) attributable to the RAP device immediately post treatment and at the 3-month follow-up visit.

Secondary Outcome Measures

Name	Time	Method
Cellulite improvement	18 weeks	A ≥15% mean reduction in the 0-5-point Cellulite Severity Scale as determined by physician assessment of Participant photographs taken before and 3 months after treatment.

Trial Locations

Locations (1)

SkinCare Physicians; 🇺🇸 Chestnut Hill, Massachusetts, United States