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Fractionated laser resurfacing is commonly used as a treatment for acne scarring in fair skinned individuals. This study aims to test the efficacy and safety in darker skin types. Patients are randomized to either the 10mJ 40mJ dosages and receive a total of five treatments at 17% one month apart. Improvement is judged by a dermatologist as 0-25%, 25-50%, 50-75% or 75-100%. Side effects such as pigmentary abnormalities and pain are also evaluated.
Background: Ablative resurfacing lasers are effective for treatment of acne scars, but they have a high risk of complications. Fractional lasers have less severe side effects but more moderate efficacy than ablative devices. Studies were performed in individuals with Fitzpatrick skin type I to VI.
Objective: To determine the efficacy and safety of an erbium 1,550-nm fractional laser in the treatment of facial acne scars in Fitzpatrick skin types IV to VI.
Methods: We conducted a prospective, single-blind, randomized trial in patients with acne scars (n=15), skin type IV to VI, with a 1,550-nm erbium fractionated laser. Patients were divided into two groups; one was treated with 10 mJ and the other with 40 mJ. Five monthly laser sessions were performed. A patient questionnaire was distributed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractional Laser 10mJ | Experimental | Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 10mJ. |
|
| Fractional Laser 40mJ | Experimental | Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 40mJ. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractionated Laser Resurfacing | Procedure |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Improvement in acne scarring. | Blinded evaluators will score improvement of acne via photographs using a quartile grading scale (0 = no improvement, 1 = minor improvement [1-25%], 2 =moderate improvement [26-50%], 3 =marked improvement [51-75%], 4 = very significant improvement [76-100%]). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspigmentation | dyspigmentation will be assessed separately from acne scarring via photographs with blinded evaluators on a scale of 1- 3. 1 (minimal amount of hyperpigmentation), 2 (moderate hyperpigmentation) and 3 (severe amount of hyperpigmentation) depending on the degree of hyperpigmentation compared with their baseline photo. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David M Ozog, MD | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 2, 2023 | |
| Reset | Nov 15, 2023 | |
| Release | Apr 16, 2024 | |
| Reset | Sep 5, 2024 | |
| Release | Apr 28, 2026 | |
| Reset | May 19, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 2, 2023 | Nov 15, 2023 | |||
| Apr 16, 2024 |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Pain with treatment | subjects will report any pain with treatment on a 0-10 scale, with zero indicating no pain and 10 indicating the worst pain | 5 months |
| Sep 5, 2024 |
| Apr 28, 2026 | May 19, 2026 |