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Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) 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: NCT03981198
Recruitment Status : Active, not recruiting
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Soliton

Brief Summary:
Feasibility study is to evaluate the safety, tolerability and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the treatment of cellulite

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

Detailed Description:
To assess the safety and tolerability of Soliton's RAP Nov Heavy for the treatment of cellulite. To assess the efficacy of Soliton's RAP Nov Heavy device for the temporary improvement in appearance of cellulite in terms of mean change in cellulite severity score (CSS).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) Nov Heavy Device for the Treatment of Cellulite
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : August 5, 2019
Estimated Study Completion Date : August 5, 2019

Arm Intervention/treatment
RAP treatment
Single RAP treatment applied to thigh and multi-treatment applied to the other thigh.
Device: Soliton Rapid Acoustic Pulse (RAP)
Treatment of legs and/or buttocks for the temporary improvement in the appearance of cellulite.
Other Name: RAP




Primary Outcome Measures :
  1. Safety [ Time Frame: 18 weeks ]
    Evaluate for adverse events attributable to the RAP device.


Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 18 ]
    To evaluate the reductions of cellulite. Achievement is measured by ≥15% mean reduction in the 0-5-point Cellulite Severity Scale as determined by physician assessment of Participant photographs taken before and 3 months after treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female ages 18-65 years
  • Participant seeking treatment of cellulite in the upper lateral thigh areas
  • Participant presenting with cellulite Grade I or II on BOTH thighs as graded using the Nurnberger-Muller scale classification (Appendix A)
  • Participant has stable weight. Body Mass Index (B.M.I.) is ≤ 30
  • Participant will not have any other cellulite treatments for 12 months before and throughout the 3-month follow-up
  • Participant is willing to participate in study and adhere to follow-up schedule
  • Participant is able to read and comprehend English
  • Participant has completed Informed Consent Form

Exclusion Criteria:

  • Participant is pregnant or planning to become pregnant during the duration of the study
  • Participant has a BMI > 30
  • Greater than 10% increase or decrease in body weight within past 6 months
  • Cellulite treatment on the thighs or buttocks in the last 12 months (Topical or non-invasive procedure)
  • 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.
  • Prior liposuction in the thighs or buttocks or any other invasive procedure to limit cellulite.
  • Medical disorder that would hinder the wound healing or immune response (no blood disorder, diabetes, inflammatory disease, etc.)

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): NCT03981198


Locations
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United States, Massachusetts
SkinCare Physicians
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Soliton
Investigators
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Study Director: Christopher C Capelli, MD Soliton

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Responsible Party: Soliton
ClinicalTrials.gov Identifier: NCT03981198    
Other Study ID Numbers: Soliton 2018-001
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: May 2019
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