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Postmarket study of Sebacia Microparticles treatment during adoption into clinical use for patients with mild to moderate inflammatory acne vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sebacia Microparticles Treatment | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sebacia Microparticles Treatment | Other | Sebacia Microparticles procedure involving microparticles and 1064 nm laser. Three treatment procedures over a two-week period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Lesion Count | Percent change in number of inflammatory lesions from baseline | Months 2, 3, 6, 9 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Global Assessment | Percent of subjects clear (IGA 0) or almost clear (IGA 1) | Months 2, 3, 6, 9 and 12 |
| Physician's Overall Assessment of Improvement | Categorical improvement from baseline (worse, no change, minimal, moderate, marked, complete) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| VP, Clinical & Regulatory Affairs | Sebacia, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Dermatology & Laser Institute | Miami | Florida | 33173 | United States | ||
| Dermatology Institute of Boston |
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| Label | URL |
|---|---|
| Company Website | View source |
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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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|
| Months 2, 3, 6, 9 and 12 |
| Boston |
| Massachusetts |
| 02116 |
| United States |
| International Clinical Research | Murfreesboro | Tennessee | 37130 | United States |
| Austin Institute for Clinical Research - Central | Austin | Texas | 78705 | United States |
| Austin Institute for Clinical Research - Pflugerville | Pflugerville | Texas | 78660 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |