Clinical trial NCT01645345: Fractional Ablative Radiofrequency for the Treatment of Acne Scars and Wrinkles
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkles
Acne Scars
Keywords: wrinkles
acne scars
Lead sponsor: Alma Lasers Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Improvement in the appearance of wrinkles and acne scars
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Glenview
country: United States
facility: Metropolitan MD
state: Illinois
city: Las Vegas
country: United States
facility: Dr. Zimmerman
state: Nevada
city: Bryn Mawr
country: United States
facility: Victoria Cirillo-Hyland
state: Pennsylvania
Study officials:
References: