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Acute UrticariaCURE-AUNCT07236372

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

A study testing Cetirizine 10 mg once daily and Cetirizine 20 mg twice daily, total 40 mg/day in people with Acute Urticaria, run by University of Phayao at 1 site in Thailand.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Acute Urticaria
What is being tested?
Cetirizine 10 mg once daily and Cetirizine 20 mg twice daily, total 40 mg/day
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteThailand
Study dates
15 Nov 2025to Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wasuchon Chaichan, MD contact

+6654466666 ext. 7020

wasuchon.ch@gmail.com

Chonlawat Chaichan, MSc contact

Chonlawat.chaichan@gmail.com

Thailand1 site, 1 recruiting
  • University of Phayao Hospital

    Phayao, Mueang, 56000

    Wasuchon Chaichan, MD, +6654466666 ext. 7020, wasuchon.ch@gmail.com

    Chonlawat Chaichan, Chonlawat.chaichan@gmail.com

    Recruiting

Other trials in Thailand

About this study

Official title: 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?
Read more

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.

Read the 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.

Conditions
Acute Urticaria
Being tested
Cetirizine 10 mg once daily, Cetirizine 20 mg twice daily, total 40 mg/day
Keywords
Acute Urticaria, Updosed Cetirizine, High-Dose Antihistamine, Standard-Dose Cetirizine, Second-Generation Antihistamine, Randomized Controlled Trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cetirizine 10 mg once dailyDrug

    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.

  • Cetirizine 20 mg twice daily, total 40 mg/dayDrug

    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.

Study groups in NCT07236372
Study groupRoleWhat they receive
Standard-dose cetirizine 10 mg orally once dailyActive comparatorParticipants 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.
Receives: Drug: Cetirizine 10 mg once daily
Updosed Cetirizine 40 mg/dayExperimentalParticipants 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.
Receives: Drug: Cetirizine 20 mg twice daily, total 40 mg/day

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From Day 0 (first dose) to Day 7 or until complete symptom resolution, whichever occurs first.

  2. 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.

    Measured: Baseline to Day 7

Secondary outcomes (3)
  1. Use of Systemic Corticosteroids as Rescue Medication

    The proportion of participants requiring systemic corticosteroids due to persistent or worsening acute urticaria symptoms despite taking the assigned study medication.

    Measured: Day 0 to Day 7

  2. Change in Dermatology Life Quality Index (DLQI)

    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.

    Measured: Baseline to Day 7

  3. Incidence and Characteristics of Adverse Events

    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.

    Measured: Day 0 to Day 7 and Week 6 follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2025
  2. Study start15 Nov 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07236372
Sponsor's protocol ID
HREC-UP-HSST 1.3/002/69
Other IDs
MD68-19
Acronym
CURE-AU
Status last verified
Oct 2026
First submitted
15 Nov 2025
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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.

    PubMed 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 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.

    PubMed 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.

    PubMed 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.

    PubMed 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, 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.

    PubMed 34536239

Questions about this trial

What is this clinical trial studying?

A study testing Cetirizine 10 mg once daily and Cetirizine 20 mg twice daily, total 40 mg/day in people with Acute Urticaria, run by University of Phayao at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wasuchon Chaichan, MD (+6654466666 ext. 7020, wasuchon.ch@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07236372, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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