drugset / Trial / NCT02031445

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

NCT02031445 ↗

Phase 2 Terminated 73 enrolled Celsus Therapeutics PLC
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

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

Outcome

Missed primary endpoint

Stopped: “Interim analysis showed lack of efficacy”

release “MRX-6 Cream Did Not Demonstrate Separation from Vehicle in Primary Endpoint of Percent Improvement in the Investigator’s Global Assessment” akaritx.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject MRX-6 Unknown 2 % Topical

Indications