drugset / Trial / NCT01352988

Efficacy and Safety of Fumaric Acid Esters (Fumaderm®) in the Treatment of Patients With Cutaneous Lupus Erythematosus

NCT01352988

Phase 2 Completed 11 enrolled University Hospital Muenster
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the therapeutic effect of fumaric acid esters (Fumaderm®) in the treatment of Cutaneous Lupus Erythematosus with respect to proportion of responders based on the Revised Cutaneous Lupus Disease Area and Severity Index (RCLASI) activity score for skin lesions at baseline and after 24 weeks of treatment or at the latest assessment for patients who withdrew prematurely (Last Observation Carried Forward, LOCF).

Timeline

Start
2011-07
Primary completion
2013-10
Completion
2014-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Fumaric acid Small molecule