Comparing Standard-Dose and High-Dose Cetirizine for Acute Urticaria (CURE-AU)

May 31, 2026 updated by: Wasuchon Chaichan, University of Phayao

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

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:

  1. Does the higher dose of cetirizine help people with acute urticaria improve faster than the standard dose?
  2. 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized, parallel-group clinical trial designed to evaluate whether a higher dose of cetirizine provides better symptom relief than the standard dose in adults with acute urticaria. Acute urticaria often causes sudden wheals and intense itching that can significantly affect comfort and daily functioning. Although standard-dose second-generation antihistamines are recommended as first-line treatment, many people do not fully improve and are frequently prescribed systemic corticosteroids, which may lead to unnecessary side effects.

This trial investigates whether increasing the dose of cetirizine to 40 mg per day offers faster or more complete symptom improvement without increasing safety risks. Participants will be randomly assigned to receive either the standard dose or the higher dose for 7 days. The study uses a blinded outcome assessment to minimize bias. Symptom severity will be measured using validated tools, and participants will be monitored for side effects throughout the study.

Laboratory tests will be used to assess kidney and liver function before and after treatment. Follow-up visits will evaluate short-term changes in symptoms as well as the potential for recurrence or progression to chronic urticaria. The findings may help guide clinical decision-making and support more rational use of antihistamines while reducing reliance on corticosteroids in acute urticaria care.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Mueang
      • Phayao, Mueang, Thailand, 56000
        • Recruiting
        • University of Phayao Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wasuchon Chaichan, MD
        • Sub-Investigator:
          • Petcharaporn Chachvarat, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 to 60 years
  • Clinical diagnosis of acute urticaria made by a physician
  • Onset of new wheals within the past 24 hours
  • Able and willing to comply with study procedures, complete symptom diaries, and attend follow-up visits
  • Provides written informed consent prior to participation

Exclusion Criteria:

  • Use of systemic corticosteroids within the past 5 days
  • Use of immunosuppressive medications within the past 5 days
  • Clinical signs of anaphylaxis, including respiratory distress, hypotension, abdominal pain, or acute laryngeal swelling
  • Presence of angioedema without wheals
  • Known diagnosis of chronic urticaria
  • Known severe renal impairment (creatinine clearance <10 mL/min), heart failure (ejection fraction <40%), or hepatic failure
  • Other skin conditions that may interfere with assessment (e.g., atopic dermatitis, eczema, bullous pemphigoid, AGEP)
  • Use of ACE inhibitors or ARBs within the past 5 days
  • Known allergy or hypersensitivity to cetirizine or components of the study medication
  • Pregnancy or breastfeeding
  • Known diabetes mellitus
  • History of gastrointestinal ulcer disease
  • Any condition that, in the investigator's judgment, would interfere with study participation or safety
  • Declines to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard-dose cetirizine 10 mg orally once daily
Participants in this arm will receive standard-dose cetirizine at 10 mg once daily for 7 days. The medication will be provided in capsule form. Participants will record their daily urticaria symptoms and return for scheduled follow-up visits to assess symptom improvement and safety outcomes.
Drug: Cetirizine 10 mg once daily
Participants in the standard-dose arm receive cetirizine 10 mg orally once daily for 7 days. The study medication is provided in capsule form to match the appearance of the high-dose capsules.
Experimental: Updosed Cetirizine 40 mg/day
Participants in this arm will receive high-dose cetirizine at 40 mg per day, taken as 20 mg twice daily for 7 days. The medication will be provided in capsule form. Participants will record their daily urticaria symptoms and return for scheduled follow-up visits to assess symptom improvement, the need for rescue medications, and any side effects.
Drug: Cetirizine 20 mg twice daily, total 40 mg/day
Participants in the high-dose arm receive cetirizine 20 mg orally twice daily (total 40 mg/day) for 7 days. The study medication is provided in capsule form to ensure identical appearance between arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Resolution of Acute Urticaria Symptoms
Time Frame: 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.
From Day 0 (first dose) to Day 7 or until complete symptom resolution, whichever occurs first.
Change in Urticaria Activity Score From Baseline
Time Frame: 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.
Baseline to Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of Systemic Corticosteroids as Rescue Medication
Time Frame: Day 0 to Day 7
The proportion of participants requiring systemic corticosteroids due to persistent or worsening acute urticaria symptoms despite taking the assigned study medication.
Day 0 to Day 7
Change in Dermatology Life Quality Index (DLQI)
Time Frame: Baseline to Day 7
The change in Dermatology Life Quality Index (DLQI) from baseline to Day 7 to assess the clinical response and quality of life impact of treatment.
Baseline to Day 7
Incidence and Characteristics of Adverse Events
Time Frame: Day 0 to Day 7 and Week 6 follow-up
Number, type, and severity of adverse events occurring during treatment with standard-dose versus high-dose cetirizine. Adverse events may include sedation, dizziness, or other treatment-related symptoms.
Day 0 to Day 7 and Week 6 follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Phayao

Investigators

  • Principal Investigator: Wasuchon Chaichan, School of Medicine, University of Phayao

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

November 15, 2025

First Submitted That Met QC Criteria

November 15, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREC-UP-HSST 1.3/002/69
  • MD68-19 (Other Grant/Funding Number: School of Medicine, University of Phayao)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because the dataset contains sensitive health information and the study sample size is small, making de-identification difficult. In addition, the informed consent form does not include permission for public sharing of individual-level data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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