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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 rosacea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Treatment 1 | Experimental | DMT310 Powder mixed with Hydrogen Peroxide |
|
| Study Treatment 2 | Experimental | Placebo powder mixed with Hydrogen Peroxide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Powder | Drug | Topical Powder mixed with diluent |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as measured by lesion counts | Inflammatory lesion counts | 12 Weeks |
| Efficacy as measured by Investigator Global Assessment (IGA) | IGA Scale: 0 Clear No papules and/or pustules
| 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:
Patient is male or non-pregnant female at least 18 years of age.
Clinical diagnosis of moderate to severe papulopustular acne rosacea as determined by:
Investigator's Global Assessment (IGA) at Randomization score of 3 or 4. Patient has at least 15 inflammatory lesions on the face
Patient is willing to apply the Investigational Product as directed
Patient is willing and able to comply with the protocol
Exclusion Criteria:
Patient is pregnant or planning to become pregnant Patient is taking a topical therapy on the face which may affect the patient's rosacea
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermata Investigational Site | Austin | Texas | 78759 | United States |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011208 | Powders |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Placebo Topical Powder |
| Drug |
Placebo Topical Powder mixed with diluent |
|