Double-Blind, Trial to Evaluate the Safety and Efficacy of MRX-6 Cream 2%
- Registration Number
- NCT02031445
- Lead Sponsor
- Celsus Therapeutics PLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 73
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo BID MRX-6 MRX-6 BID
- Primary Outcome Measures
Name Time Method Investigator's Global Assessment 4 weeks
- Secondary Outcome Measures
Name Time Method Safety 4 weeks Adverse Events
Trial Locations
- Locations (3)
Lev Yasmin Clinic
🇮🇱Natanya, Israel
Dermatology Clinic
🇮🇱Petach-Tikva, Israel
Sourasky Medical Center
🇮🇱Tel Aviv, Israel