Fractional Ablative Radiofrequency for the Treatment of Acne Scars and Wrinkles

Wrinkles Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01645345
• Other study ID #: 022012
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: March 2013

Study information

• Verified date: July 2012
• Source: Alma Lasers Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Scars
• Acne Vulgaris
• Wrinkles

Intervention

Device:
• Alma Lasers Accent RF Pixel handpiece
Treatment with fractionated RF Pixel device

Locations

Country	Name	City	State
United States	Victoria Cirillo-Hyland	Bryn Mawr	Pennsylvania
United States	Metropolitan MD	Glenview	Illinois
United States	Dr. Zimmerman	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Alma Lasers Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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