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Single center, Prospective, Open Label with Split-face Study Design. Face sides will be randomized to receive either 1064nm alone or 1064nm & 585nm combination treatment.
Each subject will receive up to 3 treatments at monthly intervals (±4 days). Follow-up visits will take place at 1, 3, and 6 months following the last treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melasma | Experimental | Treatment of Melasma Using PiQo4 Laser System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PiQo4 | Device | PiQo4 Laser System for treatment of Melasma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of subjects having an improvement of at least 1 point on the MSS or ≥ 50% MASI score improvement on at least one of the face sides at the 1-month follow-up visit. | The study will be deemed successful if the point estimate of the percent of successful subjects will be at least 50%. | 1 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of subjects having an improvement of at least 1 point on the MSS or ≥ 50% MASI score improvement on at least one of the face sides at the 3-month follow-up visit | 3 months follow up | |
| Percent of subjects having an improvement of at least 1 point on the MSS or ≥ 50% MASI score improvement on each face side |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David J Goldberg, MD | Hackensack University Medical Center - Skin Laser & Surgery Specialists Of NY & NJ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack University Medical Center - Skin Laser & Surgery Specialists Of NY & NJ | Hackensack | New Jersey | 07601 | United States |
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| ID | Term |
|---|---|
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Face sides will be randomized to receive either 1064nm alone or 1064nm & 585nm combination treatment
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| 6 months follow up |