What is cetirizine studying for acute urticaria?

Cetirizine is being studied to see if a higher dose helps relieve symptoms of acute urticaria faster than the standard dose. Researchers want to understand if increasing the dose improves symptom relief and assess the safety of the higher dose. This trial is sponsored by the University of Phayao and compares two dosing levels over 7 days.

Who may be eligible for this acute urticaria clinical trial?

Adults aged 18 to 60 with a recent diagnosis of acute urticaria may be eligible. The study includes both men and women who can follow study procedures and attend follow-ups. People who recently used steroids or immunosuppressants or who have severe kidney, heart, or liver issues may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this acute urticaria clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect their medication and check-ups to be covered during the trial.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 60Years

All Genders

ID07236372

Evaluating Standard Versus Higher Dose Cetirizine for Treating Acute Urticaria in Adults

Led by University of Phayao · Updated on 2026-06-03

140

Participants Needed

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether a higher dose of cetirizine provides better relief than the standard dose for adults with acute urticaria, a condition causing sudden itchy wheals. This clinical trial aims to understand if increasing cetirizine to 40 mg daily improves symptoms faster and is safe over a short period. The study also explores side effects and helps reduce unnecessary steroid use in treating this condition. Participants are randomly assigned to one of two groups one taking the standard 10 mg dose once daily, and the other taking a higher 40 mg dose split into two 20 mg capsules daily. Both groups take their assigned medication for 7 days, recording their daily symptoms. Follow-up visits occur on Day 3, Day 7, and Week 6 to assess symptom improvement and safety. The study uses capsules that look identical to maintain fairness. Before and after treatment, participants have blood tests to check liver and kidney function. Researchers monitor symptoms using validated tools and track the need for rescue medications like corticosteroids. The main outcomes focus on how quickly symptoms resolve and changes in urticaria activity. The study lasts through the follow-up at Week 6 to observe longer-term effects and any recurrence of symptoms.

CONDITIONS

Brief Title

Comparing Standard-Dose and High-Dose Cetirizine for Acute Urticaria

Who Can Participate

Age: 18Years - 60Years

All Genders

Eligibility Criteria

You may qualify if you...

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

You will not qualify if you...

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

Research Team

Wasuchon Chaichan, MD

Chonlawat Chaichan, MSc

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