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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

Page last updated: August 23, 2015

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