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The objective is to evaluate the tolerability, safety, and efficacy of DMT310 topical powder mixed with diluent in male and female patients with moderate to severe facial acne vulgaris
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMT310 Topical Powder | Experimental | DMT310 Powder mixed with Hydrogen Peroxide |
|
| Placebo Topical Powder | Experimental | Placebo powder mixed with Hydrogen Peroxide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMT310 | Drug | Topical Powder |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as measured by lesion counts | Inflammatory and Noninflammatory | 12 weeks |
| Efficacy as measured by Investigator Global Assessment (IGA) | 0 Clear No evidence of facial acne vulgaris
| 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events as a measure of safety and tolerability | Incidence of adverse events as a measure of safety and tolerability | 12 weeks |
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Inclusion Criteria:
Investigator's Global Assessment (IGA) at Randomization; Patient has at least 20 inflammatory lesions and at least 20 noninflammatory lesions on the face
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Dermatology Clinical Research, Inc. | Freemont | California | 94538 | United States | ||
| DermResearch |
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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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| Drug |
Placebo Topical Powder |
|
| Austin |
| Texas |
| 78759 |
| United States |