DMT310-005 Topical in the Treatment of Acne Rosacea

Phase 2

Active, not recruiting

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Study Treatment 2	Placebo Topical Powder	Placebo powder mixed with Hydrogen Peroxide
Study Treatment 1	Topical Powder	DMT310 Powder mixed with Hydrogen Peroxide

Primary Outcome Measures

Name	Time	Method
Efficacy as measured by lesion counts	12 Weeks	Inflammatory lesion counts
Efficacy as measured by Investigator Global Assessment (IGA)	12 Weeks	IGA Scale: 0 Clear No papules and/or pustules 1. Almost Clear Rare papules and/or pustules 2. Mild Few papules and/or pustules 3. Moderate Pronounced number of papules and/or pustules (but less than numerous papules and/or pustules) 4. Severe Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events as a measure of safety and tolerability	12 Weeks	Incidence of adverse events as a measure of safety and tolerability

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