Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite

Cellulite Clinical Trial

Official title:

Multi-Center Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04065711
• Other study ID #: 2019-002
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cellulite

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