Fractional Ablative Radiofrequency for the Treatment of Acne Scars and Wrinkles

Not Applicable

Completed

• Conditions: Wrinkles; Acne Scars
• Interventions: Device: Alma Lasers Accent RF Pixel handpiece

• Registration Number: NCT01645345
• Lead Sponsor: Alma Lasers Inc.

Brief Summary

To assess the safety and efficacy of the Pixel RF (fractional radio frequency) module in the treatment of acne scars and wrinkles.

Detailed Description

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).

Study Timeline

• Status Verified: 2012-07
• Study Start: 2012-07
• Study First Submitted: 2012-07-13
• Study First Submitted QC: 2012-07-18
• Study First Posted: 2012-07-20
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2020-08-20
• Last Update Posted: 2020-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Subjects meeting the following inclusion criteria may participate:

  • Male or female subject 18-60 years of age.
  • Clinically documented rolling and boxcar acne scars and/or wrinkles score of 2 or 3 per the Rao-Goldman scale (see section 6.5.1 for wrinkle classification).
  • Limitation to acne scared and wrinkles area: face.
  • Patients must commit to all follow-up visits.

Exclusion Criteria

Subjects meeting any of the following criteria will be excluded from participation:

• Bacterial or viral infection
• Impaired immune system
• Isotretinoin (Accutane, Amnesteem, Claravis, and Sotret) in the past 6 months
• Scleroderma
• Extensive radiation therapy
• Burns in the treatment area
• Poor healing in the treatment area
• Metal implants near the treatment area
• Implantable pacemaker or automatic defibrillator/cardioverter (AICD)
• Ablative/non-ablative cosmetic intervention (deep peeling) in the past 3 months in the areas to be treated
• Active cancer
• Active collagen or vascular disease
• Pregnancy or IVF procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RF Pixel handpiece treatment	Alma Lasers Accent RF Pixel handpiece	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.

Primary Outcome Measures

Name	Time	Method
Improvement in the appearance of wrinkles and acne scars	3 months	Visual assessment of the improvement in the appearance of wrinkles and acne scars after treatment with fractionated RF.

Trial Locations

Locations (3)

Metropolitan MD; 🇺🇸 Glenview, Illinois, United States

Dr. Zimmerman; 🇺🇸 Las Vegas, Nevada, United States

Victoria Cirillo-Hyland; 🇺🇸 Bryn Mawr, Pennsylvania, United States