Overview

Study to Assess Efficacy, Safety and Mechanism of Rupatadine in Cold Urticaria

Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Charite University, Berlin, Germany
Collaborator:
Hospital del Mar
Treatments:
Cyproheptadine