Fractional Ablative Radiofrequency for the Treatment of Acne Scars and Wrinkles

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.

Study Overview

• Status: Completed
• Conditions: Acne Scars; Wrinkles
• Intervention / Treatment: Device: Alma Lasers Accent RF Pixel handpiece

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Glenview, Illinois, United States, 60025
      • Metropolitan MD
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Dr. Zimmerman
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Victoria Cirillo-Hyland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in the appearance of wrinkles and acne scars	Visual assessment of the improvement in the appearance of wrinkles and acne scars after treatment with fractionated RF.	3 months

Collaborators and Investigators

• Sponsor: Alma Lasers Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: July 13, 2012
• First Submitted That Met QC Criteria: July 18, 2012
• First Posted (Estimate): July 20, 2012

Study Record Updates

• Last Update Posted (Actual): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: wrinkles; acne scars
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: 022012