NCT03545464

COrticosteroids in acUte uRticAria in emerGency dEpartment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Urticaria
• Angiœdema

Interventions

Type	Name	Description
DRUG	Placebo Oral Tablet	Placebo of cortancyl Oral Tablet 20mg
DRUG	Cortancyl Oral Tablet	Cortancyl oral Tablet 20 mg
DRUG	Levocetirizine Oral Tablet	Levocetirizine Oral Tablet 5 mg

Timeline

• Start date: 2019-09-21
• Primary completion: 2025-02-28
• Completion: 2025-09-17
• First posted: 2018-06-04
• Last updated: 2025-09-22

Locations

1 site across 1 country: France