Clinical trial NCT04065711: Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite
Official title: Multi-Center Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cellulite
Lead sponsor: Soliton
Sponsor class: INDUSTRY
First posted: 2019-08-22
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Procedure Safety- All treated participants are free from unexpected adverse events
timeFrame: 12 weeks
Secondary outcomes:
measure: RAP treatment effectiveness
timeFrame: 12 weeks, 26 weeks and 52 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Clear Dermatology and Aesthetics Center Investigate MD
state: Arizona
city: Chicago
country: United States
facility: Chicago Cosmetic Surgery & Dermatology
state: Illinois
city: Chevy Chase
country: United States
facility: Capital Laser and Skin Care
state: Maryland
city: Chestnut Hill
country: United States
facility: SkinCare Physicians
state: Massachusetts
Study officials:
affiliation: Soliton, Inc.
name: Christopher Capelli, MD
role: STUDY_DIRECTOR
References: