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To evaluate the safety and efficacy of the Cutera laser system for the treatment of acne vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cutera Laser System | Device | Subjects will receive up to 6 laser treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects Who are Responders | The primary outcome measure to evaluate the efficacy of the Cutera device is the percent of subjects who are responders at 12 weeks post final treatment, where a responder is defined as ≥ 1-point reduction on the Investigator's Global Assessment scale at follow up compared to baseline. | 12 weeks post final treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology of Boca | Boca Raton | Florida | 33431 | United States | ||
| Schweiger Dermatology PC, Reseach Division |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| Hackensack |
| New Jersey |
| 07601 |
| United States |
| Bellaire Dermatology Associates | Bellaire | Texas | 77401 | United States |