To evaluate the safety, and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the temporary improvement in the appearance of cellulite.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Treatment for the temporary improvement in the appearance of cellulite.
Clear Dermatology and Aesthetics Center Investigate MD
Scottsdale, Arizona, United States
Chicago Cosmetic Surgery & Dermatology
Chicago, Illinois, United States
Capital Laser and Skin Care
Chevy Chase, Maryland, United States
SkinCare Physicians
Chestnut Hill, Massachusetts, United States
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
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
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