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Fractional Ablative Radiofrequency for the Treatment of Acne Scars and Wrinkles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01645345
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : August 24, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Wrinkles Acne Scars Device: Alma Lasers Accent RF Pixel handpiece Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Improvement in the appearance of wrinkles and acne scars [ Time Frame: 3 months ]
    Visual assessment of the improvement in the appearance of wrinkles and acne scars after treatment with fractionated RF.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01645345

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United States, Illinois
Metropolitan MD
Glenview, Illinois, United States, 60025
United States, Nevada
Dr. Zimmerman
Las Vegas, Nevada, United States, 89148
United States, Pennsylvania
Victoria Cirillo-Hyland
Bryn Mawr, Pennsylvania, United States, 19010
Sponsors and Collaborators
Alma Lasers Inc.
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Responsible Party: Alma Lasers Inc.
ClinicalTrials.gov Identifier: NCT01645345    
Other Study ID Numbers: 022012
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: July 2012
Keywords provided by Alma Lasers Inc.:
acne scars
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases