Fractional Ablative Radiofrequency for the Treatment of Acne Scars and Wrinkles

NCT ID: NCT01645345

Last Updated: 2020-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-03-31

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).

Conditions

Wrinkles; Acne Scars

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Alma Lasers Accent RF Pixel handpiece

Intervention Type: DEVICE

Treatment with fractionated RF Pixel device

Interventions

Alma Lasers Accent RF Pixel handpiece

Treatment with fractionated RF Pixel device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alma Lasers Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Metropolitan MD

Glenview, Illinois, United States

Dr. Zimmerman

Las Vegas, Nevada, United States

Victoria Cirillo-Hyland

Bryn Mawr, Pennsylvania, United States

Countries

United States

Other Identifiers

022012

Identifier Type: -

Identifier Source: org_study_id