Fractional Ablative Radiofrequency for the Treatment of Acne Scars and Wrinkles

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Alma Lasers Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Alma Lasers Inc.
ClinicalTrials.gov Identifier:
NCT01645345
First received: July 13, 2012
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention
Wrinkles
Acne Scars
Device: Alma Lasers Accent RF Pixel handpiece

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Alma Lasers Inc.:

Primary Outcome Measures:
  • Improvement in the appearance of wrinkles and acne scars [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Visual assessment of the improvement in the appearance of wrinkles and acne scars after treatment with fractionated RF.


Estimated Enrollment: 200
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01645345

Locations
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.
  More Information

No publications provided

Responsible Party: Alma Lasers Inc.
ClinicalTrials.gov Identifier: NCT01645345     History of Changes
Other Study ID Numbers: 022012
Study First Received: July 13, 2012
Last Updated: July 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alma Lasers Inc.:
wrinkles
acne scars

Additional relevant MeSH terms:
Acne Vulgaris
Cicatrix
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014