An exploratory phase IV, randomised, double-blind, placebo controlled crossover study to assess and compare the effects of 5 mg vs. 20 mg Desloratadine on the development of experimentally induced urticaria lesions - AUDAC
- Conditions
- Acquired cold urticaria (ACU) is a frequent form of physical urticaria that is characterized by the development of wheal and flare type skin reactions after cold exposure.MedDRA version: 8.1Level: LLTClassification code 10046741Term: Urticaria cold
- Registration Number
- EUCTR2005-006133-32-DE
- Lead Sponsor
- Allergie-Centrum-Charité
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
ACU patients aged 18-70 years, signed written consent, no systemic corticosteroid or other immunosuppressive therapy, no permanent severe diseases
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
The presence of permanent severe diseases, especially those affecting the immune system, except ACU, History of adverse reactions to Desloratadine, Intake of corticoids with the last 14 days, History or presence of alcohol abuse or drug addiction, Pregnancy or breast-feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method