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

Atopic Dermatitis Clinical Trial

— C012013  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02031445
• Other study ID #: C012013
• Status: Terminated
• Phase: Phase 2
• First received: January 7, 2014
• Last updated: May 5, 2016
• Start date: August 2014
• Est. completion date: March 2015

Study information

• Verified date: May 2016
• Source: AKARI Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 73
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• MRX-6

Other:
• Placebo

Locations

Country	Name	City	State
Israel	Dermatology Clinic	Kefar Saba
Israel	Dermatology Clinic	Kiryat-Ono
Israel	Lev Yasmin Clinic	Natanya
Israel	Dermatology Clinic	Petach-Tikva
Israel	Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Celsus Therapeutics PLC

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator's Global Assessment		4 weeks	No
Secondary	Safety	Adverse Events	4 weeks	No