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

NCT07236372 | Not Yet Recruiting DMC

• 2 other identifiers: HREC-UP-HSST 1.3/002/69MD68-19
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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: 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.

Conditions

Acute Urticaria

Keywords

Acute Urticaria; Updosed Cetirizine; High-Dose Antihistamine; Standard-Dose Cetirizine; Second-Generation Antihistamine; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Time to Resolution of Acute Urticaria Symptoms

  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

  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 Outcomes (3)

• Use of Systemic Corticosteroids as Rescue Medication

  Day 0 to Day 7

• Change in Dermatology Life Quality Index (DLQI)

  Baseline to Day 7

• Incidence and Characteristics of Adverse Events

  Day 0 to Day 7 and Week 6 follow-up

Study Arms (2)

Standard-Dose Cetirizine (10 mg/day)

ACTIVE COMPARATOR

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

Updosed Cetirizine (40 mg/Day)

EXPERIMENTAL

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 40 mg

Interventions

Cetirizine 10 mg DRUG

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.

Standard-Dose Cetirizine (10 mg/day)

Cetirizine 40 mg DRUG

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.

Updosed Cetirizine (40 mg/Day)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 may not qualify if:

• Use of systemic corticosteroids within the past 5 days
• Use of antihistamines 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

Sponsors & Collaborators

• University of Phayao: lead

Study Sites (1)

University of Phayao Hospital

Phayao, Muang, 56000, Thailand

Location

Related Publications (5)

• 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 RESULT

• 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.

  PMID: 38642709 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 34536239 RESULT

MeSH Terms

Interventions

Cetirizine

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Wasuchon Chaichan

  School of Medicine, University of Phayao

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wasuchon Chaichan, MD

CONTACT

+6654466666; wasuchon.ch@gmail.com

Chonlawat Chaichan, Msc

CONTACT

Chonlawat.chaichan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Department of Internal Medicine, School of Medicine, University of Phayao

Model Details: This study uses a randomized, parallel-group design in which participants are assigned in a 1:1 ratio to receive either the standard dose or the high dose of cetirizine. A blinded outcome assessor evaluates symptom improvement to minimize measurement bias. The intervention lasts 7 days, followed by scheduled follow-up visits to assess symptom resolution, recurrence, and safety outcomes.

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 19, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)