Double-Blind, Trial to Evaluate the Safety and Efficacy of MRX-6 Cream 2%
Information source: Celsus Therapeutics PLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atopic Dermatitis
Intervention: MRX-6 (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Celsus Therapeutics PLC Official(s) and/or principal investigator(s): Avner Shemer, Prof, Principal Investigator, Affiliation: Laniado Medical Center Alex Zvulunov, Prof, Principal Investigator, Affiliation: Mayanei Hayeshua Medical Center Eli Sprecher, Prof, Principal Investigator, Affiliation: Tel-Aviv Sourasky Medical Center Dalia Gilat, Dr., Principal Investigator, Affiliation: Maccabi Healthcare Services, Israel Lili Segal, Dr., Principal Investigator, Affiliation: Mayanei Hayeshua Medical Center Jacob Mashiah, Dr., Principal Investigator, Affiliation: Dermatology Clinic, Tel Aviv, Kefar Saba
Overall contact: Pablo Jimenez, MD, Phone: 646-350-0702, Email: pj@celsustx.com
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Investigator's Global Assessment
Secondary outcome: Safety
Eligibility
Minimum age: 2 Years.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
Pablo Jimenez, MD, Phone: 646-350-0702, Email: pj@celsustx.com
Dermatology Clinic, Kefar Saba, Israel; Recruiting Alex Zvulunov, Prof., Phone: 050-7905159, Email: azvulun@bgu.ac.il Alex Zvulunov, Prof., Principal Investigator
Dermatology Clinic, Kefar Saba, Israel; Recruiting Jacob Mashiah, Phone: 054-4560927, Email: ymashiah1@gmail.com Jacob Mashiah, Principal Investigator
Dermatology Clinic, Kiryat-Ono, Israel; Recruiting Dalia Gilat, Dr., Phone: 050-8464514, Email: gilatkap@gmail.com Dalia Gilat, Dr., Principal Investigator
Lev Yasmin Clinic, Natanya, Israel; Recruiting Miriam Sror, Phone: 09-8657777, Email: miri@walla.com Avner Shemer, Principal Investigator
Dermatology Clinic, Petach-Tikva, Israel; Recruiting Lili Segal, Dr., Phone: 052-2560036, Email: dr.lilisegal@gmail.com Lili Segal, Dr., Principal Investigator
Sourasky Medical Center, Tel Aviv 64239, Israel; Recruiting Dvora Cohen, Phone: 03-6973768, Email: dvoray@tasmc.health.gov.il Inbar Cohen, Phone: 03-6973768, Email: inbarc@tlvmc.gov.il Eli Sprecher, MD, Principal Investigator
Additional Information
Starting date: July 2014
Last updated: October 14, 2014
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