Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) for the Treatment of Cellulite

Cellulite Clinical Trial

Official title:

Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) Nov Heavy Device for the Treatment of Cellulite

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03981198
• Other study ID #: Soliton 2018-001
• Status: Completed
• Phase: N/A
• Start date: July 31, 2018
• Est. completion date: August 5, 2019

Study information

• Verified date: September 2021
• Source: Soliton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Feasibility study is to evaluate the safety, tolerability and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the treatment of cellulite

Description:

To assess the safety and tolerability of Soliton's RAP Nov Heavy for the treatment of cellulite. To assess the efficacy of Soliton's RAP Nov Heavy device for the temporary improvement in appearance of cellulite in terms of mean change in cellulite severity score (CSS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 5, 2019
• Est. primary completion date: August 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Female ages 18-65 years
• Participant seeking treatment of cellulite in the upper lateral thigh areas
• Participant presenting with cellulite Grade I or II on both thighs as graded using the Nurnberger-Muller scale classification (Appendix A)
• Participant has stable weight. Body Mass Index (B.M.I.) is = 30
• Participant will not have any other cellulite treatments for 12 months before and throughout the 3-month follow-up
• Participant is willing to participate in study and adhere to follow-up schedule
• Participant is able to read and comprehend English
• Participant has completed Informed Consent Form

Exclusion Criteria:

• Participant is pregnant or planning to become pregnant during the duration of the study
• Participant has a BMI > 30
• Greater than 10% increase or decrease in body weight within past 6 months
• Cellulite treatment on the thighs or buttocks in the last 12 months (Topical or non-invasive procedure)
• 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.
• Prior liposuction in the thighs or buttocks or any other invasive procedure to limit cellulite.
• Medical disorder that would hinder the wound healing or immune response (no blood disorder, diabetes, inflammatory disease, etc.)

Related Conditions & MeSH terms

• Cellulite

Intervention

Device:
• Soliton Rapid Acoustic Pulse (RAP)
Treatment of legs and/or buttocks for the temporary improvement in the appearance of cellulite.

Locations

Country	Name	City	State
United States	SkinCare Physicians	Chestnut Hill	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Soliton

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of SAEs	The primary safety endpoint will be met if all treated Participants are free from serious adverse events (SAEs) attributable to the RAP device immediately post treatment and at the 3-month follow-up visit.	18 weeks
Primary	Treatment Tolerability	The primary endpoint will be met if a mean tolerability measure using pain scores averaged across all treated Participants is < 8.0	18 Weeks
Secondary	Cellulite improvement	A =15% mean reduction in the 0-5-point Cellulite Severity Scale as determined by physician assessment of Participant photographs taken before and 3 months after treatment.	18 weeks