Fractional Ablative Radiofrequency for the Treatment of Acne Scars and Wrinkles
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Improvement in the appearance of wrinkles and acne scars [ Time Frame: 3 months ] [ Designated as safety issue: No ]Visual assessment of the improvement in the appearance of wrinkles and acne scars after treatment with fractionated RF.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
RF Pixel handpiece treatment
There is only one arm, and that is a treatment arm. For patients with wrinkles and acne scars, they are being treated with the RF Pixel handpiece to decrease the appearance of these cosmetic deficiencies. The improvement is documented in before and after photographs.
Device: Alma Lasers Accent RF Pixel handpiece
Treatment with fractionated RF Pixel device
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01645345
|United States, Illinois|
|GlenView, Illinois, United States, 60025|
|United States, Nevada|
|Las Vegas, Nevada, United States, 89148|
|United States, Pennsylvania|
|Bryn Mawr, Pennsylvania, United States, 19010|