Double-Blind, Trial to Evaluate the Safety and Efficacy of MRX-6 Cream 2%

Study Overview
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Brief Summary
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Randomized, double-blind, parallel group, placebo-controlled, multicenter, efficacy and safety study in subjects with mild to moderate atopic dermatitis. Following the double blind period, subjects will be allowed to continue treatment with topical MRX-6 Cream 2% in an open-label extension. Demonstrate the efficacy of MRX-6 Cream 2% compared to Vehicle for the treatment of the signs and symptoms of atopic dermatitis and demonstrate the safety of MRX-6 Cream 2% for the treatment of the signs and symptoms of atopic dermatitis.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of MRX-6 Cream 2% in Pediatric Subjects With Mild to Moderate Atopic Dermatitis Followed by an Open Label Extension

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: MRX-6
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects, ≥2 years of age and ≤17 years of age, of any race or ethnicity Must have clinical diagnosis of mild to moderate atopic dermatitis (AD) at both Screening and Baseline Visits, defined as IGA score of 2 or 3 (Hanifin and Rajka, Rothe 1980) Must have AD affecting ≥ 5% total body surface area (TBSA) at Baseline History of AD for at least 3 months prior to Baseline Informed consent/assent in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline (21 CFR §50.25[c]) and applicable regulations, before completing any study-related procedures Exclusion Criteria: Use of topical corticosteroids within 7 days prior to Baseline Use of systemic corticosteroids, topical calcineurin inhibitors, photo-therapy (eg, PUVA, UVB) or immunosuppressive therapy (eg, cyclosporine) within 14 days prior to Baseline Subjects that require systemic therapy for the treatment of atopic dermatitis Use of systemic anti-infective or antibiotic treatment within 14 days prior to Baseline Subjects who present with clinical conditions other than AD that may interfere with the evaluation (eg, generalized erythroderma, acne, Netherton's Syndrome, psoriasis) Secondary infection of AD (bacterial, viral or fungal) within the skin area under study or open skin infections in any area at Baseline Women of childbearing potential who are lactating or pregnant as determined by urine pregnancy test at Screening. • History of MRX-6 cream 2% sensitivity or to any component of the test article History of severe anxiety and/or depression; any history of suicide attempt Subjects with a history of human immunodeficiency virus (HIV) as determined by medical history Subjects with any screening clinical laboratory result outside the normal range that is clinically relevant in the opinion of an appropriately qualified physician Subjects who, in the opinion of the Investigator, would be non compliant with the visit schedule or study procedures Participation in any other investigational trial within 6 weeks of Baseline, or during study conduct Chronic condition(s) which are either unstable or not adequately controlled Use of non-sedating anti-histamines within 7 days of first dose or at any time during study conduct Drug or alcohol abuse, mental dysfunction, or other condition limiting the subject's ability to be compliant with study-related procedures

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>BID | Other: Placebo<br> <br> |
| Experimental: MRX-6<br>BID | Drug: MRX-6<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Assessment |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Adverse Events | 4 weeks |