Acne Clinical Trial
Official title:
Evaluation of a Novel Fractional Resurfacing Device for the Treatment of Acne Scarring
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).
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
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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