Fractional Resurfacing Device for Treatment of Acne Scarring
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|ClinicalTrials.gov Identifier: NCT00585286|
Recruitment Status : Completed
First Posted : January 3, 2008
Results First Posted : December 2, 2013
Last Update Posted : January 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Acne Scar||Device: 10,600 nm fractional carbon dioxide laser system||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of a Novel Fractional Resurfacing Device for the Treatment of Acne Scarring|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
Experimental: Fractional carbon dioxide laser system
Thirty total healthy subjects from two research centers with skin type I-IV of moderate to severe acne scarring received treatment with the 10,600 nm fractional carbon dioxide laser system.
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
Other Name: Fraxel Re:pair laser
- Overall Improvement of Acne Scarring [ Time Frame: Baseline, 1 month and 3 months post-treatment ]Subject assessment of the percent improvement of acne scarring compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
- Average Improvement in Surface Texture [ Time Frame: Baseline, 1 month and 3 months post-treatment ]Subject assessment of the percent improvement of surface texture compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
- Degree of Atrophy [ Time Frame: Baseline, 1 month and 3 months post-treatment ]Subject assessment of the percent improvement in extent of atrophy compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
- Pain Tolerance [ Time Frame: At treatment visit (up to 3 visits) ]The average pain score reported over all three treatments was 5.67, corresponding to "moderate" pain based on a 10-point scale. The pain score is recorded on a 10-point scale, with 0 being "no pain" and 10 being "worst pain imaginable." All subjects reported that any discomfort associated with the procedure was only during active intervention and resolved immediately post-procedure. Increased pain scores correlated with increased density, but not increased energy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585286
|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|
|Principal Investigator:||Brian D Zelickson, MD||Department of Dermatology, University of Minnesota, Minneapolis, Minnesota|