Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.
Eligible patients will receive 3 treatments (4-6 weeks apart) on the facial acne scars using Sofwave System. Treatment may be administered after the enrollment and screening at the first visit, or it may occur later following the enrollment and screening activities based on site scheduling availabilities. All patients will return to the clinic for one follow up visit at 3 months ± 3 weeks post last treatment (FU1). Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues.
SLSS, a Division of Schweiger Dermatology Group Research Office
Hackensack, New Jersey, United States
UnionDerm
New York, New York, United States
Laser & Skin Surgery Center of New York®
New York, New York, United States
New York Laser & Skin Care
New York, New York, United States
Rate of change of acne scars appearance, as assessed by independent masked evaluators at 3 months post last treatment session.
following Sofwave treatments based on 6 points simplified Acne Severity Scale (ASS), as evaluated by independent masked reviewers.
Time frame: 1 year
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