Status:
COMPLETED
Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite
Lead Sponsor:
Soliton
Conditions:
Cellulite
Eligibility:
FEMALE
18-50 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2021
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04065711
Start Date
July 20 2019
End Date
August 26 2021
Last Update
September 22 2021
Active Locations (4)
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1
Clear Dermatology and Aesthetics Center Investigate MD
Scottsdale, Arizona, United States, 85255
2
Chicago Cosmetic Surgery & Dermatology
Chicago, Illinois, United States, 60654
3
Capital Laser and Skin Care
Chevy Chase, Maryland, United States, 20815
4
SkinCare Physicians
Chestnut Hill, Massachusetts, United States, 02467