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

NCT02031445 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2016-05-06

No results posted yet for this study

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

Interventions

DRUG

MRX-6

OTHER

Placebo

Sponsors & Collaborators

  • Celsus Therapeutics PLC

    lead INDUSTRY

Principal Investigators

  • Avner Shemer, Prof · Laniado Medical Center

  • Alex Zvulunov, Prof · Mayanei Hayeshua Medical Center

  • Eli Sprecher, Prof · Tel-Aviv Sourasky Medical Center

  • Dalia Gilat, Dr. · Maccabi Healthcare Services, Israel

  • Lili Segal, Dr. · Mayanei Hayeshua Medical Center

  • Jacob Mashiah, Dr. · Dermatology Clinic, Tel Aviv, Kefar Saba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Israel

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02031445 on ClinicalTrials.gov