DMT310-003 Topical in the Treatment of Acne Vulgaris | NCT04106778

NCT04106778

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Treatment 1	Experimental	DMT310 Powder mixed with Hydrogen Peroxide	Drug: DMT310
Study Treatment 2	Experimental	Placebo powder mixed with Hydrogen Peroxide	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
DMT310	Drug	Topical Powder	Study Treatment 1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy as measured by lesion counts	Inflammatory and Noninflammatory	12 Weeks
Efficacy as measured by Investigator Global Assessment (IGA)	0 None No evidence of facial acne vulgaris Minimal Few noninflammatory lesions (comedones) are present; a few inflammatory lesions(papules/pustules) may be present; no nodulo-cystic lesions are allowed) Mild Several to many noninflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed Moderate Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed Severe Significant degree of inflammatory disease; papules/pustules are a predominant feature; a few nodulo-cystic lesions may be present; comedones may be present	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

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Dermata Investigational Site		Austin	Texas	78759	United States

Condition Browse Module

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases