Cellulite
Conditions
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.
Interventions
DEVICESoliton's Rapid Acoustic Pulse (RAP)
Treatment for the temporary improvement in the appearance of cellulite.
Sponsors
Soliton
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Safety- All treated participants are free from unexpected adverse events | 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
| Measure | Time frame | Description |
|---|---|---|
| RAP treatment effectiveness | 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. |
Countries
United States
Outcome results
None listed