Hospital Louis MOURIER
Colombes, Île-de-France Region, 92700, France
NCT Number: NCT03545464
To demonstrate the non-inferiority of the efficacy of a single antihistamine in comparison with an association of antihistamine and corticosteroid in the treatment of acute urticaria in emergency departments
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Colombes, Île-de-France Region, 92700, France
Acute urticaria (hives) is a common skin disease. The prevalence of acute urticaria in life is about 15 to 20% in the general population. It is responsible for a frequent use of emergency departments (ED). The usual treatment is based on early administration of an association of antihistamines and corticosteroid. The therapeutic efficacy of corticosteroids has never been established by high evidence studies. However, corticosteroids are frequently used. When stopped, corticosteroids could promote the occurence of urticaria recurrences, and a transition to chronic urticaria. In addition, corticosteroids may be rarely responsible for gastrointestinal bleeding, hypertension and diabetes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Placebo of cortancyl Oral Tablet 20mg
Cortancyl oral Tablet 20 mg
Levocetirizine Oral Tablet 5 mg
Time frame: For 7 day
Urticaria Activity Score (UAS) is a daily combined score of severity of itch and number of hives. Each component of the UAS is scored on a scale of 0 to 3; the 2 scores are added together for a daily total of 0 to 6.
Time frame: For 7 day
The UAS 7 is the sum of the daily UAS scores over 7 days. This questionnaire will be completed by the patient and the investigator.
Time frame: beyond 6 Weeks
wheals and/or itch for > 6 weeks
Time frame: up to 3 month
angioedema
Time frame: up to 3 month
emergency visits
Time frame: up to 6 months
The DLQI is a dermatology-specific quality of life questionnaire designed for use in patients over 16 years of age
Time frame: at day 7, at day 14, at 6 week, at 3 months and 6 months
The CU-Q2oL (French version) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being
Assistance Publique - Hôpitaux de Paris
Other
Acronym: COURAGE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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