A Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Cold Urticaria Lesions

Study Overview
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Brief Summary
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The aim of this study is to compare cold urticaria lesions by thermography, volumetry and digital time lapse photography in ACU patients treated with placebo, 5 mg and 20 mg desloratadine. Hypothesis: The updosing of desloratadine (20 mg)is more effective in the treatment of ACU symptoms as compared to standard doses (5 mg desloratadine) and placebo.

Official Title
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An Exploratory Phase IV, Randomised, Double-Blind, Placebo Controlled Crossover Study to Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Experimentally Induced Urticaria Lesions

Conditions
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Acquired Cold Urticaria

Intervention / Treatment
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* Drug: desloratadine
* Drug: desloratadine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients with ACU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch. History of beneficial effects of antihistaminic treatment. Age between 18 and 75 years. Female patients must be using a highly effective method of birth control (such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence,vasectomised partner), or they must be postmenopausal, surgically sterilised, or hysterectomised. Voluntarily signed written informed consent. Exclusion Criteria: The presence of permanent severe diseases, especially those affecting the immune system, except ACU The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract) History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy Evidence of severe renal dysfunction Evidence of significant hepatic disease (liver enzymes twice the upper reference value) History of adverse reactions to DL, loratadine, or other ingredients of the IMP Presence of active cancer which requires chemotherapy or radiation therapy Presence of acute urticaria, angioedema, or larynx edema History or presence of alcohol abuse or drug addiction Participation in any clinical trial within 4 weeks prior to enrolment Commitment to an institution in terms of § 40 Abs. 1 Nr. 4 AMG Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study Intake of oral corticosteroids within 14 days prior to the beginning of the study Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study Pregnancy or breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>desloratadine 20 mg | Drug: desloratadine<br>* single dose for 7 days, oral, 20mg<br>|
| Active Comparator: 2<br>desloratadine 5 mg | Drug: desloratadine<br>* single dose for 7 days, oral, 5 mg<br>|
| Placebo Comparator: 3<br> | Drug: placebo<br>* single dose for 7 days, oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the development of urticaria lesions (wheal and flare) induced by TempTest challenge as assessed by digital time lapse photography, volumetry and thermography. |  | 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in critical temperature thresholds and increase in critical stimulation time thresholds as assessed by standardized TempTest challenge. |  | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urticaria, cold urticaria, acquired cold urticaria