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

• Status: Terminated
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celsus Therapeutics PLC

Criteria

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