Double-Blind, Trial to Evaluate the Safety and Efficacy of MRX-6 Cream 2% (C012013)

Celsus Therapeutics

Status and phase

Terminated

Phase 2

Conditions

Atopic Dermatitis

Treatments

Other: Placebo

Drug: MRX-6

Study type

Interventional

Funder types

Industry

Identifiers

NCT02031445

C012013

Details and patient eligibility

About

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.

Enrollment

73 patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

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