L50.2
Conditions
Interventions
Group 1: Patients with cold induced reactions and cold urticaria fill out a patient questionnaire (ACUSI®, DLQI®) and are interviewed through a physician (checklist).
Further:
- 1 blood sampling
- L
Sponsors
Charité Campus Mitte Klinik für Dermatologie, Venerologie und Allergologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients with a historical or physical evidence of CRs can be enrolled in the study.
Exclusion criteria
Exclusion criteria: Exclusion criteria are the following drugs that could affect cold stimulation testing results: H1-antihistamines taken 3 or less days before enrollment (5½ plasma half-lives of drug elimination should be allowed) and/or glucocorticosteroids received 7 or less days before enrollment. LST should not be done at skin sites affected by urticaria in the last 24 hours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| COLD-CE aims globally improve the understanding of cold urticaria and cold-induced anaphylaxis and to determine optimal evaluation strategies of patients experiencing CRs (cold-induced reactions). The study will run for 1 year. Starting July 2020 all results will be analyzed and validated. | — |
Secondary
| Measure | Time frame |
|---|---|
| A definition of percise criterias for an increased risk of systemic reactions (and consequently for prevention of anaphylaxis and an epinephrine autoinjector prescription). Assessment of health-related quality of life (especially in patients with high temperature thresholds living in countries with cold climates). Developement of new therapeutic recommendations. The study will run for 1 year. Starting July 2020 all results will be analyzed and validated. | — |
Countries
Denmark, France, Germany, Russia, Slovenia, Thailand
Contacts
Public ContactDorothea Terhorst-Molawi
Charité Campus Mitte Klinik für Dermatologie, Venerologie und Allergologie
Outcome results
None listed