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COrticosteroids in acUte uRticAria in emerGency dEpartment

COrticosteroids in acUte uRticAria in emerGency dEpartment

Non Recruiting
18 years and older
All
Phase 3

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Overview

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

Description

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.

Eligibility

Inclusion Criteria:

  • Age > 18 years
  • Isolated acute urticaria (acute hives): spontaneous urticaria, inducible urticaria
  • Acute urticaria with angioedema without laryngeal edema
  • Obtain patient's consent
  • Social security affiliation

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Acute hives with anaphylaxis
  • Bradykinin angioedema
  • Angioedema without urticaria (hives)
  • Laryngeal edema with urticaria (hives)
  • Corticosteroid administration in the previous 5 days visiting the emergency department
  • Antihistamines greater than 1 tablet per day in the previous 5 days visiting the ED
  • Other treatment for urticaria : omalizumab, montelukast, ciclosporin A
  • Chronic urticaria before acute urticaria diagnosis
  • Atopic dermatitis
  • Eczema
  • Bullous pemphigoid
  • Acute exanthematous pustulosis
  • Diabetes mellitus
  • Gastrointestinal ulcer
  • Refusal to participate
  • Known allergy to the study drugs or formulation ingredients
  • Known Renal failure defined by creatinine clearance < 10 mL/min or cardiac failure defined by ejection fraction < 40%.
  • Corticoid use in 5 days prior to randomisation
  • Contra-indication to corticotherapy:
  • Any live vaccine
  • Psychotic states still uncontrolled by treatment limiting the participant's compliance with the research

Study details
    Urticaria
    Angiœdema

NCT03545464

Assistance Publique - Hôpitaux de Paris

20 August 2025

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