NCT00585286

Fractional Resurfacing Device for Treatment of Acne Scarring

Evaluation of a Novel Fractional Resurfacing Device for the Treatment of Acne Scarring

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to evaluate the safety and effectiveness of a new investigational laser device for treatment of acne scarring, for improvement in the appearance of surface texture and topography (recessed or uneven surfaces).

Detailed description

Thirty subjects between two research locations with an acne scar severity score greater than 4 will receive up to 3 treatments with an FDA IDE and Institutional Review Board approved 10,600nm fractional carbon dioxide laser system. Improvement of acne scarring is evaluated at 1 month and 3 months post-treatment. Post-treatment responses evaluated are immediate erythema, immediate edema, and any other immediate responses. Evaluations are conducted immediate post treatment and one week post-treatment. Key safety data include the severity scoring of post-treatment responses, as well as by photodocumentation. The incidence of side effects such as scarring, pigmentary changes, etc. are evaluated at follow-up visits one and three months post-treatment. Key safety data include the incidence rates and severity scoring of side effects, as well as by photodocumentation

Conditions

• Acne
• Scar

Interventions

Type	Name	Description
DEVICE	10,600 nm fractional carbon dioxide laser system	1-3 laser treatments using 20-100 millijoules (mJ) with 100-400 microscopic treatment zones (MTZ)/cm2 per pass and total density of 600-1200 MTZ/cm2

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2008-01-03
• Last updated: 2014-01-15
• Results posted: 2013-12-02

Locations

1 site across 1 country: United States