Clinical trial NCT05199506: Study to Evaluate the Safety and Effectiveness of the RAP Device for the Improvement in the Appearance of Cellulite
Official title: A Single Center Prospective Study to Evaluate the Safety and Effectiveness of the Soliton® Rapid Acoustic Pulse (RAP)™Device for the Improvement in the Appearance of Cellulite.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cellulite
Lead sponsor: Soliton
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this single site clinical study is to evaluate the safety and effectiveness of the Soliton Rapid Acoustic Pulse (RAP) device for the improvement of cellulite comparing two different RAP treatment doses.

Detailed description: This is a non-significant risk, single-center, prospective trial for safety, and efficacy using Soliton's RAP device for the improvement in the appearance of cellulite performed at 1 (one) clinical research site in the United States.

Approximately 15 healthy female participants between the age of 18-55 inclusive will be enrolled in this study.

Participants who sign the informed consent form and meet all the eligible criteria will be enrolled in the study. Each participant will undergo acoustic rapid pulse (RAP) treatments on each of the participants buttocks and legs. The participant's right buttock and leg will receive 100 Hz doses, and the participants left buttock and leg will receive 50 Hz doses.

Total study duration is anticipated to be at or less than 55 weeks from the first participant visit to the last participant observation visit. A total of 3 visits, plus two optional visits are planned for this study as listed below:

* Visit 1: Baseline/Screening (-30 Days to Day 0)
* Visit 2: Treatment (Day 0)
* Visit 3: 12-week Follow-Up Visit (+/- 14 Days)
* Visit 4: 26-week Follow-Up Visit (+/- 14 Days) (Optional)
* Visit 5: 52 Week Follow-Up Visit (+/- 14 Days) (Optional)

Eligibility criteria: Inclusion Criteria:

* Seeking treatment of cellulite in the thigh and/or buttock areas
* Area of moderate to severe cellulite on thigh and/or buttock for both legs using the Cellulite Dimple - At Rest Scale at Baseline with grades of 2 or 3 based on review of photos taken under the same lightening conditions planned for the trial.
* 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.
* Participant will not have used spray-on tanning treatments for 6 months prior to the initiation of the trial. Furthermore, participants will not use spray-on tanning treatments during the term of the trial.
* Participants must be able to provide written informed consent, understand and is willing to comply with all study related procedures and follow-up visits.

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.
* Participant is unwilling to commit to follow-up visits
* 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.
* History of coagulopathy(ies) and/or on anticoagulant medication.
* Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
* Any surgical procedure in the treatment areas in the prior 3 months or planned during the duration of the study.
* Participant is a current smoker.
* Participant has tattoo in treatment area.

Primary outcomes:
measure: Assessing safety
timeFrame: Immediately post treatment
measure: Assessing safety
timeFrame: 12 weeks post treatment
measure: Assessing Efficacy
timeFrame: At 12 week follow up visit
Secondary outcomes:
measure: Assessing Participant Satisfaction
timeFrame: At the 12 week follow up visit
Other outcomes:
Locations:
city: Nashville
country: United States
facility: The Practice of Brian Biesman
state: Tennessee
Study officials:
affiliation: Sponsor GmbH
name: Chris Capelli, MD
role: STUDY_DIRECTOR
References: