Wrinkles Clinical Trial
Official title:
RF Pixel With Micro-Plasma Technology: Fractional Ablative Radiofrequency for the Treatment of Acne Scars and RF Pixel With Micro-Plasma Technology: Fractional Ablative Radiofrequency for the Treatment of Acne Scars and
To assess the safety and efficacy of the Pixel RF (fractional radio frequency) module in the treatment of acne scars and wrinkles.
The study design will be a prospective open label study. Up to 20 subjects of both genders
with acne scars and/or wrinkles in the face will be recruited. The subjects will be treated
once on clean acne scarred skin and three times on the the wrinkled skin with the Pixel RF
handpiece. Each treatment duration will be approximately 30 minutes. The initial power and
number of passes parameters shall be set according to the clinical indication and skin type
of the subject treated (as well as the results of test sites).
Clinical improvement will be assessed by the investigator physician from the visual
appearance of the treated area according to the following scale: -1 for exacerbation, 0 no
change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4
for 75%-99% improvement. Adverse side effects will be scored by clinical evaluation of
erythema, edema, and burns. Real-time assessments will be made as well by the investigators.
Treatment and results will be documented in a Case Report Form and follow-up sessions (1, 5
days after the treatment and 1 month and 3 months after the treatment).
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