Clinical trial NCT02031445: Double-Blind, Trial to Evaluate the Safety and Efficacy of MRX-6 Cream 2%
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: AKARI Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-01-09
Enrollment: 73
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Investigator's Global Assessment
timeFrame: 4 weeks
Secondary outcomes:
measure: Safety
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Kefar Saba
country: Israel
facility: Dermatology Clinic
city: Kiryat-Ono
country: Israel
facility: Dermatology Clinic
city: Natanya
country: Israel
facility: Lev Yasmin Clinic
city: Petach-Tikva
country: Israel
facility: Dermatology Clinic
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Laniado Medical Center
name: Avner Shemer, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayanei Hayeshua Medical Center
name: Alex Zvulunov, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel-Aviv Sourasky Medical Center
name: Eli Sprecher, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Maccabi Healthcare Services, Israel
name: Dalia Gilat, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayanei Hayeshua Medical Center
name: Lili Segal, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Clinic, Tel Aviv, Kefar Saba
name: Jacob Mashiah, Dr.
role: PRINCIPAL_INVESTIGATOR
References: