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| Name | Class |
|---|---|
| Reliant Technologies, Inc. Mountain View, CA | INDUSTRY |
| University of Minnesota | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractional carbon dioxide laser system | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10,600 nm fractional carbon dioxide laser system | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | Baseline, 1 month and 3 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher B Zachary, MBBS, FRCP | University of California, Irvine | Principal Investigator |
| Brian D Zelickson, MD | Department of Dermatology, University of Minnesota, Minneapolis, Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Irvine Dermatology Clinical Research Center | Irvine | California | 92697 | United States |
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| Label | URL |
|---|---|
| University of California, Irvine Department of Dermatology Clinical Research | View source |
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Subjects must not have been treated with other lasers, chemical procedures, or other cosmetic procedures on the area to be treated within 12 months of enrollment.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fractional Carbon Dioxide Laser System | Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional carbon dioxide laser system. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Of 30 patients enrolled between two research centers, 15 subjects were enrolled at the UC Irvine General Clinical Research Center
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| ID | Title | Description |
|---|---|---|
| BG000 | Fractional CO2 Laser System | Thirty healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 month and 3 months post-treatment |
|
Adverse event data was collected over the entire study for approximately 1 year and 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fractional CO2 Laser System | Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system. |
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There were no major limitations to this trial. The trial was completed without any technical problems or major complications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Zachary, FRCP, MBBS/Prinicipal Investigator | University of California, Irvine | (949) 824-7103 | czachary@uci.edu |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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|
| At treatment visit (up to 3 visits) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | 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). | Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study. | Posted | Median | Standard Deviation | units on a scale | Baseline, 1 month and 3 months post-treatment |
|
|
|
| Primary | 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). | Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study. | Posted | Median | Standard Deviation | units on a scale | Baseline, 1 month and 3 months post-treatment |
|
|
|
| Secondary | 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. | Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study. | Posted | Mean | Standard Deviation | units on a scale | At treatment visit (up to 3 visits) |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
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| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |