Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of participants will receive DMT210 Gel while the other half will receive vehicle control.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMT210 Topical Gel | Experimental | DMT210 Topical Gel 5% applied to the face twice daily for 12 weeks |
|
| Vehicle Control | Placebo Comparator | Topical Gel vehicle applied to the face twice daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMT210 Topical Gel 5% | Drug |
| ||
| Vehicle Control |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as measured by Inflammatory lesion counts | Inflammatory lesion counts | 12 weeks |
| Efficacy as measured by Investigator Global Assessment (IGA) | Investigator Global Assessment (IGA) | 12 weeks |
| Efficacy as measured by 5-point Clinical Erythema Assessment (CEA) | 5-point Clinical Erythema Assessment (CEA) | 12 weeks |
| Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA) | 5-point Patient Severity Assessment of Erythema (PSA) | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermata Investigational Site | San Diego | California | United States | |||
| Dermata Investigational Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012393 | Rosacea |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Miami |
| Florida |
| United States |
| Dermata Investigational Site | Fridley | Minnesota | United States |
| Dermata Investigational Site | Omaha | Nebraska | United States |
| Dermata Investigational Site | High Point | North Carolina | United States |
| Dermata Investigational Site | Broomall | Pennsylvania | United States |
| Dermata Investigational Site | Nashville | Tennessee | United States |
| Dermata Investigational Site | Austin | Texas | United States |
| Dermata Investigational Site | Norfolk | Virginia | United States |