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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065711
Recruitment Status : Active, not recruiting
First Posted : August 22, 2019
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Soliton

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.

Condition or disease Intervention/treatment Phase
Cellulite Device: Soliton's Rapid Acoustic Pulse (RAP) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-Center Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : December 12, 2020
Estimated Study Completion Date : January 30, 2021

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.




Primary Outcome Measures :
  1. Procedure Safety- All treated participants are free from unexpected adverse events [ Time Frame: 12 weeks ]

    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 :
  1. RAP treatment effectiveness [ Time Frame: 12 weeks, 26 weeks and 52 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study is specific to females ages 18-50 years.
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065711


Locations
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United States, Arizona
Clear Dermatology and Aesthetics Center Investigate MD
Scottsdale, Arizona, United States, 85255
United States, Illinois
Chicago Cosmetic Surgery & Dermatology
Chicago, Illinois, United States, 60654
United States, Maryland
Capital Laser and Skin Care
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
SkinCare Physicians
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Soliton
Investigators
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Study Director: Christopher Capelli, MD Soliton, Inc.
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Responsible Party: Soliton
ClinicalTrials.gov Identifier: NCT04065711    
Other Study ID Numbers: 2019-002
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Cellulite
Skin Manifestations
Signs and Symptoms