Who is sponsoring CURE-AU?

CURE-AU is sponsored by University of Phayao.

What condition does CURE-AU study?

CURE-AU studies Acute Urticaria.

What drugs are being tested in CURE-AU?

Interventions: Cetirizine 10 mg, Cetirizine 40 mg.

What is the status of CURE-AU?

CURE-AU is currently NOT_YET_RECRUITING.

Last reviewed 2025-11-15 · How we verify

Comparative Efficacy of Standard-Dose Versus Updosed Cetirizine in Acute Urticaria: A Randomized Controlled Trial (CURE-AU)

NCT07236372 NA NOT_YET_RECRUITING

The goal of this clinical trial is to learn whether a higher dose of cetirizine works better than the standard dose to relieve symptoms of acute urticaria (hives) in adults. The study also aims to learn about the safety of taking a higher dose for a short period of time. The main questions the study aims to answer are: Does the higher dose of cetirizine help people with acute urticaria improve faster than the standard dose? What side effects do participants experience when taking the higher dose? Researchers will compare two groups: one group taking the standard dose of cetirizine (10 mg per day) and another group taking a higher dose (40 mg per day). This will help researchers understand which dose works better and whether the higher dose is safe. Participants will: Take the assigned study medication for 7 days Record their daily symptoms, including itch and hive severity Return for follow-up visits on Day 3, Day 7, and Week 6 Have blood tests to check liver and kidney function before and after treatment This study may help improve treatment options for people with acute urticaria and reduce the need for unnecessary steroid use.

Details

Lead sponsor	University of Phayao
Phase	NA
Status	NOT_YET_RECRUITING
Enrolment	140
Start date	2025-11
Completion	2026-10

Conditions

Acute Urticaria

Interventions

Cetirizine 10 mg
Cetirizine 40 mg

Primary outcomes

Time to Resolution of Acute Urticaria Symptoms — From Day 0 (first dose) to Day 7 or until complete symptom resolution, whichever occurs first.
The time from the first dose of study medication to the complete resolution of acute urticaria symptoms, defined as the absence of hives and an itch score of 0 for at least 24 consecutive hours. Symptom status will be assessed using patient-reported daily symptom diaries and validated scoring tools.
Change in Urticaria Activity Score From Baseline — Baseline to Day 7
The change in total UAS7 score from baseline to Day 7, based on daily patient-reported wheal and itch scores collected in symptom diaries.

Countries

Thailand