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Procedure

Each leg/buttock will be treated with the RAP device for Cellulite

N/A
Waitlist Available
Research Sponsored by Soliton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Participant will not have had invasive or energy-based cellulite treatments (liposuction, subcision, RF, laser, ESWT, etc.) for the prior 12 months.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks post treatment
Awards & highlights

Study 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.

Eligible Conditions
  • Cellulite

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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The person has moderate to severe cellulite on their 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.
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Participants must not have had invasive or energy-based cellulite treatments (liposuction, subcision, RF, laser, ESWT, etc.) in the past twelve months.
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The participant will not have used any topical treatments for cellulite in the past 6 months, and will not use any during the trial.
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Participants must not have used spray-on tanning treatments for six months prior to the start of the study, and they must not use them during the study.
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kg/m2 The body mass index is 30 kilograms per meter squared or less.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessing Efficacy
Assessing safety
Secondary outcome measures
Assessing Participant Satisfaction

Trial Design

1Treatment groups
Experimental Treatment
Group I: Each leg/buttock will be treated with the RAP deviceExperimental Treatment1 Intervention
Each leg will be treated with standard RAP treatment settings.One leg will receive treatments with 100Hz and the other with 50hz
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RAP
2021
N/A
~20

Find a Location

Who is running the clinical trial?

SolitonLead Sponsor
6 Previous Clinical Trials
165 Total Patients Enrolled
2 Trials studying Cellulite
77 Patients Enrolled for Cellulite
Chris Capelli, MDStudy DirectorSponsor GmbH
1 Previous Clinical Trials
40 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Connecticut
Alabama
Other
North Carolina
How old are they?
18 - 65
What site did they apply to?
The Practice of Brian Biesman
What portion of applicants met pre-screening criteria?
Met criteria
~4 spots leftby Mar 2025