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Sponsors and Collaborators: |
University of California, Irvine Reliant Technologies, Inc. Mountain View, CA |
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Information provided by: | University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00585286 |
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).
Condition | Intervention | Phase |
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Acne Scarring |
Device: 10,600 nm fractional CO2 laser system |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of a Novel Fractional Resurfacing Device for the Treatment of Acne Scarring |
Enrollment: | 15 |
Study Start Date: | March 2007 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Fractional CO2 laser treatment
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Device: 10,600 nm fractional CO2 laser system
1-3 laser treatments using 20-70 mJ with 600-1200 MTZ/cm2
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Fifteen subjects with an acne scar severity score greater than 4 will receive up to 3 treatments with an FDA IDE and IRB approved 10,600nm fractional CO2 laser system. Improvement of acne scarring is evaluated at 72 hours, 1 week, 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 evaluted 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
Ages Eligible for Study: | 30 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UC Irvine Dermatology Clinical Research Center | |
Irvine, California, United States, 92697 |
Principal Investigator: | Christopher B Zachary, MBBS, FRCP | University of California, Irvine |
Responsible Party: | University of California, Irvine ( Christopher B. Zachary, MBBS, FRCP ) |
Study ID Numbers: | 2006-5328 |
Study First Received: | December 26, 2007 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00585286 |
Health Authority: | United States: Food and Drug Administration |
acne vulgaris scarring laser |
Exanthema Facial Dermatoses Facies Skin Diseases |
Sebaceous Gland Diseases Acne Vulgaris Cicatrix |
Acneiform Eruptions |