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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04065711
Other study ID # 2019-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 20, 2019
Est. completion date August 26, 2021

Study information

Verified date September 2021
Source Soliton
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the safety, and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the temporary improvement in the appearance of cellulite.


Description:

Multi-site clinical study to evaluate the safety, efficacy and tolerability of Soliton's Rapid Acoustic Pulse (RAP) device fo the temporary improvement in the appearance of cellulite.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date August 26, 2021
Est. primary completion date July 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Female ages 18-50 years - Seeking treatment of cellulite in the thigh and/or buttock areas - Area of severe cellulite on the thigh and/or buttock with an average simplified Cellulite Severity Scale at Baseline = 4.0 (Table 2) - Having at least one dimple, or ridge-depression, in the treatment area, with a depth of approximately 5 mm or greater. - Stable weight nominally +/- 5% for at least the past 6 months. - 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. - Will not undergo any other cellulite treatments for a period of 12 months following RAP treatment. - Participant is willing to participate in study and adhere to follow-up schedule - Participant is able to read and comprehend English - Participant has completed the Informed Consent Form 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. - Has atrophic scars, or has a history of atrophic scars or keloids. - Tattoo or former tattoo at or near treatment area. - 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. - Medical disorder that would hinder the wound healing or immune response (no blood disorder, inflammatory disease, etc.). - History of coagulopathy(ies) and/or on anticoagulant medication. - Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area. - Current smoker. - Any surgical procedure in the prior 3 months, or planned during the duration of the study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Soliton's Rapid Acoustic Pulse (RAP)
Treatment for the temporary improvement in the appearance of cellulite.

Locations

Country Name City State
United States SkinCare Physicians Chestnut Hill Massachusetts
United States Capital Laser and Skin Care Chevy Chase Maryland
United States Chicago Cosmetic Surgery & Dermatology Chicago Illinois
United States Clear Dermatology and Aesthetics Center Investigate MD Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
Soliton

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Procedure Safety- All treated participants are free from unexpected adverse events The primary objective is to demonstrate freedom from unexpected adverse
events (UAEs) and serious adverse events (SAEs) directly attributable to the RAP device or treatment.
12 weeks
Secondary RAP treatment effectiveness To demonstrate temporary improvement in the appearance of cellulite as determined by blinded independent physician assessment (IPA) correctly identifying the 12-week post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. 12 weeks, 26 weeks and 52 weeks
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