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

NCT02031445 | Terminated Phase 2

• 1 other identifier: C012013
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 5

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Investigator's Global Assessment

  4 weeks

Secondary Outcomes (1)

• Safety

  4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

BID

Other: Placebo

MRX-6

EXPERIMENTAL

BID

Drug: MRX-6

Interventions

MRX-6 DRUG

MRX-6

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celsus Therapeutics PLC: lead

Study Sites (5)

Dermatology Clinic

Kfar Saba, Israel

Location

Dermatology Clinic

Kiryat Ono, Israel

Location

Lev Yasmin Clinic

Netanya, Israel

Location

Dermatology Clinic

Petah Tikva, Israel

Location

Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 9, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 6, 2016

Record last verified: 2016-05

Locations

IL (5)