Feasibility study is to evaluate the safety, tolerability and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the treatment of cellulite
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
Treatment of legs and/or buttocks for the temporary improvement in the appearance of cellulite.
SkinCare Physicians
Chestnut Hill, Massachusetts, United States
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.
Time frame: 18 weeks
Treatment Tolerability
The primary endpoint will be met if a mean tolerability measure using pain scores averaged across all treated Participants is \< 8.0
Time frame: 18 Weeks
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.
Time frame: 18 weeks
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