drugset / Trial / NCT00470912

Sunscreen RV 2457C in Photoinduced CLE

NCT00470912 ↗

Phase 3 Completed 25 enrolled Heinrich-Heine University, Duesseldorf
RandomizedParallel-groupDouble-blindPrevention

Summary

Lupus erythematosus (LE) is characterized by a large clinical spectrum, and sunligt is a well established factor in the induction and exacerbation of this disease. In all subsets of LE, skin lesions occur preferentially in sun-exposed areas. Previous studies have demonstrated that the lesions in LE patients reproduced in controlled experimental conditions. The initial reports suggested that the action spectrum for the LE was in the UVB range (290 to 320 nm), but more recent studies have demonstrated that UVA (320 to 400 nm) can contribute to the induction of LE skin lesions. Antimalarial agents and topical steroids are the main treatments of chronic LE. The second line therapies include retinoids, sulfones, immunosuppressor agents, systemic corticosteroid and thalidomide. Moreover, patients are advised to avoid sun, to wear sunprotective clothing and to apply sunscreen. The aim of this study was to assess the efficacy of a sunscreen milk with high protection factor against UV-B and UV-A, used exclusively, in the photoinduced LE.

Timeline

Start
2001-05
Primary completion
—
Completion
2002-02

Drugs

EvaluationDrugModalityDoseRoute
Subject RV 2547C Unknown — —