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CompletedNCT04065711Updated Sep 22, 2021

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

An interventional study of Soliton's Rapid Acoustic Pulse (RAP) in Cellulite, sponsored by Soliton. Completed at 4 sites in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-22.

Sponsored by Soliton · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
67
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cellulite

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03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
67 participants (actual)

Study arms

  • 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)

Interventions

  • DeviceSoliton's Rapid Acoustic Pulse (RAP)

    Treatment for the temporary improvement in the appearance of cellulite.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 weeks, 26 weeks and 52 weeks

06

Study locations

4 sites
  • Clear Dermatology and Aesthetics Center Investigate MD
    Scottsdale, Arizona 85255, United States
  • Chicago Cosmetic Surgery & Dermatology
    Chicago, Illinois 60654, United States
  • Capital Laser and Skin Care
    Chevy Chase, Maryland 20815, United States
  • SkinCare Physicians
    Chestnut Hill, Massachusetts 02467, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04065711
Lead sponsor
Soliton
Responsible party
Sponsor
First posted
Aug 22, 2019
Start date
Jul 20, 2019
Primary completion
Jul 20, 2021
Completion
Aug 26, 2021
Last update
Sep 22, 2021

Study contacts

Christopher Capelli, MD
study director · Soliton, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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