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The study stopped because patient enrollment requirements were not met.
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This proof of concept study will be conducted to assess the aesthetic improvement in refractory mixed type melasma in subjects treated with two FDA 510K approved devices: Q Switched Nd: YAG Laser vs. Alex TriVantage
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revlite Q switched Nd:YAG laser | Experimental | Revlite Q switched Nd:YAG laser 1064 nm |
|
| TriVantage Q switched Nd:YAG laser | Experimental | TriVantage Q switched Nd:YAG laser 1064nm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revlite Q switched Nd:YAG | Device | Revlite Q switched Nd:YAG 1064nm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Melasma Determined by Physician | The Global Aesthetic Improvement scale was used to determine the amount of improvement. This scale ranges from 1 to 5, where 1 is very much improved, 2 is much improved, 3 is improved, 4 is no change, and 5 is worsened. | 3 months post last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Universal Pain Scale for Subject Tolerability | The subject pain tolerability was assessed using the Universal Pain Scale. This scale ranges from 0 (no pain) to 10 (worst pain possible). | 3 months post last treatment |
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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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This was a comparative study where the device was used outside of the recommended treatment usage. It was used to assess the Revlite device for feasibility and not health outcomes.
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| Trivantage Q switched Nd: YAG | Device | Trivantage Q switched Nd: YAG 1064nm |
|