Fractional Ablative Radiofrequency for the Treatment of Acne Scars and Wrinkles

NCT01645345 | Completed

• 1 other identifier: 022012
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Wrinkles; Acne Scars

Keywords

wrinkles; acne scars

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

RF Pixel handpiece treatment

OTHER

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

Interventions

Alma Lasers Accent RF Pixel handpiece DEVICE

Treatment with fractionated RF Pixel device

RF Pixel handpiece treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alma Lasers Inc.: lead

Study Sites (3)

Metropolitan MD

Glenview, Illinois, 60025, United States

Location

Dr. Zimmerman

Las Vegas, Nevada, 89148, United States

Location

Victoria Cirillo-Hyland

Bryn Mawr, Pennsylvania, 19010, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: July 20, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 24, 2020

Record last verified: 2012-07

Locations

US (3)