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Clinical Trial 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).


Clinical Trial 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 ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00585286
Study type Interventional
Source University of California, Irvine
Contact
Status Completed
Phase Phase 1/Phase 2
Start date March 2007
Completion date July 2008

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