Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Double-blind, Three-way Cross-over, Placebo-controlled Study to Assess the Efficacy, Safety and Mechanisms of Treatment With Rupatadine 20 mg and 40 mg in Cold Contact Urticaria<
Brief Summary:
Main objective of this study is to evaluate the efficacy of rupatadine in 20 mg and 40 mg doses in the development of symptoms of cold contact urticaria. For this purpose, a Peltier element-based electronic provocation device (TempTest®, emo systems GmbH, Berlin, Germany) will be used. This allows skin exposure to 12 different temperatures from 4 to 42 °C simultaneously in a standardized and reproducible way and thus the determination of individual temperature and/or stimulation time thresholds.
In addition mediators related from activated must cells such as histamine, PAF, PGD2 should be identified in the period between the application of stimulus and the appearance of symptoms of cold urticaria and should be characterized qualitatively and quantitatively.