DMT310-001 Topical in the Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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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.

Official Title
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A Study of Tolerability, Safety, And Efficacy, of DMT310 In Patients With Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: DMT310
* Drug: Hydrogen Peroxide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 acne vulgaris as determined by: Investigator's Global Assessment (IGA) at Randomization Patient has at least 20 but not more than 50 inflammatory lesions on the face Patient has at least 20 but not more than 100 noninflammatory 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 acne

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Treatment 1<br>DMT310 Powder mixed with Hydrogen Peroxide | Drug: DMT310<br>* Topical Powder<br>Drug: Hydrogen Peroxide<br>* Liquid Diluent<br>|
| Experimental: Study Treatment 2<br>DMT310 Powder mixed with Placebo Diluent | Drug: DMT310<br>* Topical Powder<br>|
| Experimental: Study Treatment 3<br>Placebo powder mixed with Hydrogen Peroxide | Drug: Hydrogen Peroxide<br>* Liquid Diluent<br>Drug: Placebo<br>* Placebo Topical Powder<br>|
| Placebo Comparator: Control<br>Placebo powder mixed with Placebo Diluent | Drug: Placebo<br>* Placebo Topical Powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |