Atopic Dermatitis
Conditions
Brief 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.
Interventions
DRUGMRX-6
OTHERPlacebo
Sponsors
Celsus Therapeutics PLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator's Global Assessment | 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 4 weeks | Adverse Events |
Countries
Israel
Outcome results
None listed