A Phase 1/2 interventional study of 10,600 nm fractional carbon dioxide laser system in Acne and Scar, sponsored by University of California, Irvine. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-01-15.
Sponsored by University of California, Irvine · Phase 1/2, Interventional, and Treatment
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
307 studies on the registry are indexed under Cicatrix; 50 are open to participants now.
This study's enrollment of 15 is below the median of 39 across 251 interventional studies indexed under Cicatrix.
Browse Cicatrix studies →University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
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Exclusion Criteria:
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
Also known as: Fraxel Re:pair laser
Overall Improvement of Acne Scarring
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).
Time frame: Baseline, 1 month and 3 months post-treatment
Average Improvement in Surface Texture
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).
Time frame: Baseline, 1 month and 3 months post-treatment
Degree of Atrophy
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).
Time frame: Baseline, 1 month and 3 months post-treatment
Pain Tolerance
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.
Time frame: At treatment visit (up to 3 visits)
30 total patients with moderate to severe acne scarring were recruited from 3/2007-5/2008 between two locations. Of these, 15 patients received treatment and 14 patients completed the full course of the study at the University of California, Irvine General Clinical Research Center.
| Milestone | Fractional Carbon Dioxide Laser System |
|---|---|
| Started | 15 |
| Completed | 14 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
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).
| units on a scale | Fractional CO2 Laser System |
|---|---|
| Month 1 | 2.26 ± 1.15 |
| Month 3 | 1.91 ± 1.0 |
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).
| units on a scale | Fractional CO2 Laser System |
|---|---|
| Month 1 | 1.94 ± 1.16 |
| Month 3 | 2.09 ± 0.85 |
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).
| units on a scale | Fractional CO2 Laser System |
|---|---|
| Month 1 | 1.68 ± 1.11 |
| Month 3 | 1.65 ± 1.14 |
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.
| units on a scale | Fractional CO2 Laser System |
|---|---|
| Pain Tolerance | 5.67 ± 0.833 |
Collected over Adverse event data was collected over the entire study for approximately 1 year and 3 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fractional CO2 Laser System | — | 0/15 (0%) | 0/15 (0%) |
Of 30 patients enrolled between two research centers, 15 subjects were enrolled at the UC Irvine General Clinical Research Center
| Age, Categorical(Participants) | Fractional CO2 Laser System |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 15 |
| >=65 years | 0 |
| Age, Continuous(years) | Fractional CO2 Laser System |
|---|---|
| Mean | 36 ± 13 |
| Sex: Female, Male(Participants) | Fractional CO2 Laser System |
|---|---|
| Female | 9 |
| Male | 6 |
| Region of Enrollment(participants) | Fractional CO2 Laser System |
|---|---|
| United States | 15 |
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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University of California, Irvine