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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).
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
Yes
Metropolitan MD
Glenview, Illinois, United States
Dr. Zimmerman
Las Vegas, Nevada, United States
Victoria Cirillo-Hyland
Bryn Mawr, Pennsylvania, United States
Start Date
July 1, 2012
Primary Completion Date
March 1, 2013
Completion Date
March 1, 2013
Last Updated
August 24, 2020
200
ACTUAL participants
Alma Lasers Accent RF Pixel handpiece
DEVICE
Lead Sponsor
Alma Lasers Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07255261