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To study the effect of fractionated 1927-nm non ablative thulium laser in reduction of post inflammatory hyperpigmentation (PIH) using a validated and reproducible model for studying PIH.
The design of the study consists of a total of six visits including one initial screening visit within 107-127 days depending on the scheduling of your screening and subsequent visits. Assessments such as visual examination, photography, Investigatory Global Assessment (IGA) of pigmentation and erythema; Colorimetry; and Diffuse Reflectance Spectroscopy of the intended treatment area will be conducted at Visits 1-5. Optional biopsies will be taken at various time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractional laser patients treated with laser | Experimental | Laser with topical steroid and laser with vehicle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients treated with laser | Device | Patients treated with laser with topical steroid Patients treated with laser with vehicle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Pigmentation in all 5 subjects | Measured clinical with IGA objectively with colometry | Visit 1 (Day 0) through Visit 5 (Day 112 ±5) |
| Measure | Description | Time Frame |
|---|---|---|
| Immunohistochemical changes in pigmentation in all 5 subjects | Histology assess parameter including pigmentation | Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5) |
| Immunohistochemical changes in inflammation in all 5 subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fanar Razoky, Bachelors | Contact | 313-694-1923 | frazoky1@hfhs.org | |
| Mohammad Tasneem, MD | Contact | 313-916-2151 | TMOHAMM2@hfhs.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Medical Center | Recruiting | Detroit | Michigan | 48202 | United States |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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Histology assess parameter including inflammation
| Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5) |