Acquired Cold Urticaria
Conditions
Keywords
urticaria, cold urticaria, acquired cold urticaria
Brief summary
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.
Interventions
DRUGdesloratadine
single dose for 7 days, oral, 20mg
DRUGplacebo
single dose for 7 days, oral
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Outpatients with ACU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch. 2. History of beneficial effects of antihistaminic treatment. 3. Age between 18 and 75 years. 4. 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. 5. Voluntarily signed written informed consent.
Exclusion criteria
1. The presence of permanent severe diseases, especially those affecting the immune system, except ACU 2. The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract) 3. History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia 4. History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy 5. Evidence of severe renal dysfunction 6. Evidence of significant hepatic disease (liver enzymes twice the upper reference value) 7. History of adverse reactions to DL, loratadine, or other ingredients of the IMP 8. Presence of active cancer which requires chemotherapy or radiation therapy 9. Presence of acute urticaria, angioedema, or larynx edema 10. History or presence of alcohol abuse or drug addiction 11. Participation in any clinical trial within 4 weeks prior to enrolment 12. Commitment to an institution in terms of § 40 Abs. 1 Nr. 4 AMG 13. Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study 14. Intake of oral corticosteroids within 14 days prior to the beginning of the study 15. Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study 16. Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Decrease in critical temperature thresholds and increase in critical stimulation time thresholds as assessed by standardized TempTest challenge. | 15 minutes |
Countries
Germany
Outcome results
None listed