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The intended use of the Alexandrite laser device used in this study is to assess the efficacy and safety of the Alexandrite laser device for the treatment of acne scars on skin types V and VI.
Subjects are to be enrolled in this clinical study if they are 18-65 years old. A maximum of 25 subjects will be enrolled at 1 study center. Subjects will receive up to 6 treatments (minimum of 4 treatment visits with an optional 5th and 6th treatment) on the face. Subjects will return for follow up visits at 30 and 90 days post last treatment. All subjects will receive a phone call 1 week after each treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alexandrite Laser | Experimental | Single arm, self-controlled |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: RF Device Arm | Device | Non-invasive radiofrequency Alexandrite laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Photographic Evaluation of Changes in Treatment Areas | Photographic evaluation with ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading comparing pre-treatment images to the 90 day follow up images performed by independent reviewers. This scale gives higher scores based on the number of scars, with the description of the scars determining the weighting factor. The scale ranges from 0 to 540, with a lower score meaning less severe scarring. | Baseline and 90 day follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Photographic Evaluation of Treatment Areas | Photographic evaluation with ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading comparing pre-treatment images to the 30 day follow up images performed by independent reviewers. This scale gives higher scores based on the number of scars, with the description of the scars determining the weighting factor. The scale ranges from 0 to 540, with a lower score meaning less severe scarring. |
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Inclusion Criteria:
Exclusion Criteria:
Cautionary Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Civiok | Cynosure, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wallace Skin and Body Institute | Los Angeles | California | 90056 | United States | ||
| Laser & Skin Surgery Center of New York |
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| Baseline and 30 day follow up |
| Blinded evaluation of pre-treatment images vs. follow up images to determine which image is which | Blind identification of pre-treatment images vs. 30 day follow up images performed by independent reviewers. | Baseline and 30 day follow up |
| Blinded evaluation of pre-treatment images vs. follow up images to determine which image is which | Blind identification of pre-treatment images vs. 90 day follow up images performed by independent reviewers. | Baseline and 90 day follow up |
| Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS) | Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS) at the 30 day follow up visit. The GAIS scale ranges from 1 to 5, with 1 being "very much improved," 2 being "much improved," 3 being "improved," 4 being "no change," and 5 being "worse." | Baseline and 30 day follow up |
| Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS) | Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS) at the 90 day follow up visit. The GAIS scale ranges from 1 to 5, with 1 being "very much improved," 2 being "much improved," 3 being "improved," 4 being "no change," and 5 being "worse." | Baseline and 90 day follow up |
| Subject assessment using the Global Aesthetic Improvement Scale (SGAIS) | Subject assessment using the Global Aesthetic Improvement Scale (SGAIS) at the 30 follow up visit. The GAIS scale ranges from 1 to 5, with 1 being "very much improved," 2 being "much improved," 3 being "improved," 4 being "no change," and 5 being "worse." | Baseline and 30 day follow up |
| Subject assessment using the Global Aesthetic Improvement Scale (SGAIS) | Subject assessment using the Global Aesthetic Improvement Scale (SGAIS) at the 90 follow up visit. The GAIS scale ranges from 1 to 5, with 1 being "very much improved," 2 being "much improved," 3 being "improved," 4 being "no change," and 5 being "worse." | Baseline and 90 day follow up |
| Subject satisfaction | Subject satisfaction rates at the 30 day follow up visit. The subject satisfaction scale ranges from 1 to 6, with 1 being extremely unsatisfied, 2 being dissatisfied, 3 being slightly unsatisfied, 4 being slightly satisfied, 5 being satisfied, and 6 being extremely satisfied. | 30 day follow up |
| Subject satisfaction | Subject satisfaction rates at the 90 day follow up visit. The subject satisfaction scale ranges from 1 to 6, with 1 being extremely unsatisfied, 2 being dissatisfied, 3 being slightly unsatisfied, 4 being slightly satisfied, 5 being satisfied, and 6 being extremely satisfied. | 90 day follow up |
| New York |
| New York |
| 10016 |
| United States |