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The purpose of this study is to compare a hydroquinone skin care regimen alone to a combination of Revlite Laser treatment with a hydroquinone skin care regimen for the treatment of melasma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revlite Laser System with Topical | Experimental | Revlite Laser System for the Treatment of Melasma and hydroquinone skin care regimen |
|
| Topical | Active Comparator | Hydroquinone skin care regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revlite Laser System with hydroquinone skin care regimen | Device | Revlite Laser System with hydroquinone skin care regimen for the Treatment of Melasma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Adverse Events Among Patients | Adverse events were collected and reported to test the safety and efficacy of the device. | From study baseline to completion, approximately 1 year. However, adverse events not resolved by then will be followed up with until they are resolved. |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction Questionnaire | Physician and subject satisfaction will be ranked on a scale from 1 to 5, where 1 is extremely dissatisfied and 6 is extremely satisfied. | 1 month post last treatment |
| Photographic Evaluation using the Global Aesthetic Improvement Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Krantz | Cynosure, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NY Laser and Skin Care | New York | New York | 10028 | 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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| Hydroquinone skin care regimen | Other | Hydroquinone skin care regimen for the Treatment of Melasma |
|
Photos will be a taken at baseline and post treatment and then improvement assessed using the Global Aesthetic Improvement Scale. This scale ranges from 0 to 3, where 0 is 0-25% clearance from baseline photograph, 1 is 25-50% clearance from baseline photograph, 2 is 50-75% clearance from baseline photograph, and 3 is 75-100% clearance from baseline photograph. |
| 1 month post last treatment |