A Study to Assess the Adverse Events and Effectiveness of Rapid Acoustic Pulse (RAP) Device for the Appearance of Cellulite in Adult Participants
Cellulite
About this trial
This is an interventional treatment trial for Cellulite focused on measuring Rapid Acoustic Pulse, RAP, Cellulite
Eligibility Criteria
Inclusion Criteria: Participants seeking treatment of cellulite in the thigh and/or buttock areas. Areas of moderate to severe cellulite on bilateral thigh and/or buttock 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. Participant will not have had invasive or energy-based cellulite (liposuction, subcision, RF, laser, ESWT, cryo-lipolysis, muscle stimulation, etc.) treatments in the treatment areas in the prior 12 months. Participant will not have used topical based cellulite treatments for prior 3 months and will not use during the trial Participant will not have used spray-on tanning treatments for 3 months prior to or during the term of the trial. Exclusion Criteria: Metal or plastic implants (vascular stent, or implants in the hips, knees, etc.) in the treatment areas. Active electronic implants such as pacemakers, defibrillators History of coagulopathy and/or on anticoagulant medication Skin disorders (skin infections or rashes, psoriasis, etc.) in the treatment areas. Medical disorder that would hinder wound healing or immune response. Any surgical procedure in the treatment areas in the prior 3 months or planned during the duration of the study. Any other condition/disease/situation which, as deemed by the PI, would preclude participant from safely participating in or completing the study visits or that may confound study results.
Sites / Locations
- Innovation Research CenterRecruiting
Arms of the Study
Arm 1
Experimental
Rapid Acoustic Pulse (RAP)
Participants will receive 3 separate RAP cellulite treatments sessions.