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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
137
Placebo of cortancyl Oral Tablet 20mg
Cortancyl oral Tablet 20 mg
Levocetirizine Oral Tablet 5 mg
Hospital Louis MOURIER
Colombes, Île-de-France Region, France
7-Days Urticaria Activity Score (UAS 7) at day 7
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
Recurrence of hives at day 7 and/or recurrence of itch at day 7
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: For 7 day
Occurrence of spontaneous wheals and/or itch for > 6 weeks
wheals and/or itch for \> 6 weeks
Time frame: beyond 6 Weeks
Patients with angioedema at day 7, 14 and 3 months
angioedema
Time frame: up to 3 month
The reduction of morbidity is assessed by new emergency visits for acute urticaria recurrences at day 7, 14 and 3 months
emergency visits
Time frame: up to 3 month
(DLQI) 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: up to 6 months
Cu-Q2QoL up to 6 months
The CU-Q2oL (French version) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being
Time frame: at day 7, at day 14, at 6 week, at 3 months and 6 months
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