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

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

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

Study Overview

• Status: Completed
• Conditions: Cellulite
• Intervention / Treatment: Device: Soliton's Rapid Acoustic Pulse (RAP)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Clear Dermatology and Aesthetics Center Investigate MD
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Chicago Cosmetic Surgery & Dermatology
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Capital Laser and Skin Care
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • SkinCare Physicians

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: RAP Treatment; Each treatment area will receive 30-40 minutes (30-40 individual doses) of RAP treatment.	Device: Soliton's Rapid Acoustic Pulse (RAP); Treatment for the temporary improvement in the appearance of cellulite.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Soliton
• Investigators: Study Director: Christopher Capelli, MD, Soliton, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2019
• Primary Completion (ACTUAL): July 20, 2021
• Study Completion (ACTUAL): August 26, 2021

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (ACTUAL): August 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations; Cellulite
• Other Study ID Numbers: 2019-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No