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

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

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.

Study Overview

• Status: Terminated
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Placebo; Drug: MRX-6

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Kefar Saba, Israel
    • Dermatology Clinic
  • Kiryat-Ono, Israel
    • Dermatology Clinic
  • Natanya, Israel
    • Lev Yasmin Clinic
  • Petach-Tikva, Israel
    • Dermatology Clinic
  • Tel Aviv, Israel, 64239
    • Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; BID	Other: Placebo
Experimental: MRX-6; BID	Drug: MRX-6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Investigator's Global Assessment	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Adverse Events	4 weeks

Collaborators and Investigators

• Sponsor: Celsus Therapeutics PLC
• Investigators: Principal Investigator: Avner Shemer, Prof, Laniado Medical Center; Principal Investigator: Alex Zvulunov, Prof, Mayanei HaYeshua Medical Center; Principal Investigator: Eli Sprecher, Prof, Tel-Aviv Sourasky Medical Center; Principal Investigator: Dalia Gilat, Dr., Maccabi Healthcare Services, Israel; Principal Investigator: Lili Segal, Dr., Mayanei HaYeshua Medical Center; Principal Investigator: Jacob Mashiah, Dr., Dermatology Clinic, Tel Aviv, Kefar Saba

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 7, 2014
• First Posted (Estimate): January 9, 2014

Study Record Updates

• Last Update Posted (Estimate): May 6, 2016
• Last Update Submitted That Met QC Criteria: May 5, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: C012013