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This prospective, open-label study will be conducted in 15 healthy subjects per clinical site ages 14 or older who meet the inclusion/exclusion criteria. Each subject may have up to 5 lesions treated on the face, chest or back with the Acleara insert. Subjects will receive up to 3 follow up visits and evaluated for improvement in acne lesions and monitored for any adverse events.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acleara Acne Treatment System | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Subject assessment of reduction in acne lesion size | Percentage range of lesion reduction | 24-72 hours, 1-2 weeks, 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles County Dermatology Associates | White Plains | Maryland | 20695-3064 | United States | ||
| Bellaire Dermatology Associates |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 12, 2015 | |
| Reset | May 29, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 12, 2015 | May 29, 2015 |
| 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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| Bellaire |
| Texas |
| 77401 |
| United States |