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

NCT ID: NCT04065711

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-20
• Study Completion Date: 2021-08-26

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.

Conditions

Cellulite

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RAP Treatment

Each treatment area will receive 30-40 minutes (30-40 individual doses) of RAP treatment.

Group Type: EXPERIMENTAL

Soliton's Rapid Acoustic Pulse (RAP)

Intervention Type: DEVICE

Treatment for the temporary improvement in the appearance of cellulite.

Interventions

Soliton's Rapid Acoustic Pulse (RAP)

Treatment for the temporary improvement in the appearance of cellulite.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Soliton

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Capelli, MD

Role: STUDY_DIRECTOR

Soliton, Inc.

Locations

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

Countries

United States

Other Identifiers

2019-002

Identifier Type: -

Identifier Source: org_study_id