Fractional Resurfacing Device for Treatment of Acne Scarring
|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|
|Primary Completion Date :||July 2008|
|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.
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|