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

Official title

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

Overview

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.

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.

Interventions

• 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.
• 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.

Primary outcome measures

• 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.]
• Change in Urticaria Activity Score From Baseline [Time frame: Baseline to Day 7]

Secondary outcome measures (3)

• Use of Systemic Corticosteroids as Rescue Medication [Time frame: Day 0 to Day 7]
• Change in Dermatology Life Quality Index (DLQI) [Time frame: Baseline to Day 7]
• Incidence and Characteristics of Adverse Events [Time frame: Day 0 to Day 7 and Week 6 follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Thailand · 1 center

• University of Phayao Hospital — Phayao

Publications

• Jamjanya S, Danpanichkul P, Ongsupankul S, Taweesap S, Thavorn K, Hutton B, Ruengorn C, Bernstein JA, Chuamanochan M, Nochaiwong S. Evaluation of Pharmacological Treatments for Acute Urticaria: A Systematic Review and Meta-Analysis. J Allergy Clin Immunol Pract. 2024 May;12(5):1313-1325. doi: 10.1016/j.jaip.2024.01.022. Epub 2024 Jan 25. PMID 38280453
• Chu X, Wang J, Ologundudu L, Brignardello-Petersen R, Guyatt GH, Oykhman P, Bernstein JA, Saini SS, Beck LA, Waserman S, Moellman J, Khan DA, Ben-Shoshan M, Baker DR, Oliver ET, Sheikh J, Lang D, Mathur SK, Winders T, Eftekhari S, Gardner DD, Runyon L, Asiniwasis RN, Cole EF, Chan J, Wheeler KE, Trayes KP, Tran P, Chu DK. Efficacy and Safety of Systemic Corticosteroids for Urticaria: A Systematic PMID 38642709
• Badloe FMS, Grosber M, Ring J, Kortekaas Krohn I, Gutermuth J. Treatment of acute urticaria: A systematic review. J Eur Acad Dermatol Venereol. 2024 Nov;38(11):2082-2092. doi: 10.1111/jdv.19904. Epub 2024 Feb 29. PMID 38420865
• Okubo Y, Shigoka Y, Yamazaki M, Tsuboi R. Double dose of cetirizine hydrochloride is effective for patients with urticaria resistant: a prospective, randomized, non-blinded, comparative clinical study and assessment of quality of life. J Dermatolog Treat. 2013 Apr;24(2):153-60. doi: 10.3109/09546634.2011.608783. Epub 2011 Aug 24. PMID 21810005
• Zuberbier T, Abdul Latiff AH, Abuzakouk M, Aquilina S, Asero R, Baker D, Ballmer-Weber B, Bangert C, Ben-Shoshan M, Bernstein JA, Bindslev-Jensen C, Brockow K, Brzoza Z, Chong Neto HJ, Church MK, Criado PR, Danilycheva IV, Dressler C, Ensina LF, Fonacier L, Gaskins M, Gaspar K, Gelincik A, Gimenez-Arnau A, Godse K, Goncalo M, Grattan C, Grosber M, Hamelmann E, Hebert J, Hide M, Kaplan A, Kapp A, K PMID 34536239

Identifiers

NCT: NCT07236372 · HREC-UP-HSST 1.3/002/69 · MD68-19

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗