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

Primary Purpose

Cellulite

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Soliton's Rapid Acoustic Pulse (RAP)
Sponsored by
Soliton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cellulite

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Clear Dermatology and Aesthetics Center Investigate MD
  • Chicago Cosmetic Surgery & Dermatology
  • Capital Laser and Skin Care
  • SkinCare Physicians

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RAP Treatment

Arm Description

Each treatment area will receive 30-40 minutes (30-40 individual doses) of RAP treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 20, 2019
Last Updated
September 21, 2021
Sponsor
Soliton
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1. Study Identification

Unique Protocol Identification Number
NCT04065711
Brief Title
Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite
Official Title
Multi-Center Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 20, 2019 (Actual)
Primary Completion Date
July 20, 2021 (Actual)
Study Completion Date
August 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soliton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulite

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RAP Treatment
Arm Type
Experimental
Arm Description
Each treatment area will receive 30-40 minutes (30-40 individual doses) of RAP treatment.
Intervention Type
Device
Intervention Name(s)
Soliton's Rapid Acoustic Pulse (RAP)
Intervention Description
Treatment for the temporary improvement in the appearance of cellulite.
Primary Outcome Measure Information:
Title
Procedure Safety- All treated participants are free from unexpected adverse events
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
RAP treatment effectiveness
Description
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.
Time Frame
12 weeks, 26 weeks and 52 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study is specific to females ages 18-50 years.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Capelli, MD
Organizational Affiliation
Soliton, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clear Dermatology and Aesthetics Center Investigate MD
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
Chicago Cosmetic Surgery & Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
Capital Laser and Skin Care
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
SkinCare Physicians
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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