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

Summary

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.

Timeline

Start

2025-11-15

Primary completion

2026-06

Completion

2026-10

Publications

• Results 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.
• Results 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 Review and Meta-Analysis of Randomized Clinical Trials. J Allergy Clin Immunol Pract. 2024 Jul;12(7):1879-1889.e8. doi: 10.1016/j.jaip.2024.04.016. Epub 2024 Apr 18.
• Results 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.
• Results 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.
• Results 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, Kessel A, Kocaturk E, Kulthanan K, Larenas-Linnemann D, Lauerma A, Leslie TA, Magerl M, Makris M, Meshkova RY, Metz M, Micallef D, Mortz CG, Nast A, Oude-Elberink H, Pawankar R, Pigatto PD, Ratti Sisa H, Rojo Gutierrez MI, Saini SS, Schmid-Grendelmeier P, Sekerel BE, Siebenhaar F, Siiskonen H, Soria A, Staubach-Renz P, Stingeni L, Sussman G, Szegedi A, Thomsen SF, Vadasz Z, Vestergaard C, Wedi B, Zhao Z, Maurer M. The international EAACI/GA(2)LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2022 Mar;77(3):734-766. doi: 10.1111/all.15090. Epub 2021 Oct 20.

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