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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01645345

Enrollment

200

Registered

2012-07-20

Start date

2012-07-31

Completion date

2013-03-31

Last updated

2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Scars, Wrinkles

Keywords

wrinkles, acne scars

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).

Interventions

DEVICEAlma Lasers Accent RF Pixel handpiece

Treatment with fractionated RF Pixel device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026