Efficacy of Bilastine Up-dosing (40 mg ) Versus Combination of Bilastine (20 mg )With Levocitirizine (5 mg) in the Treatment of Chronic Spontaneous Urticaria

January 23, 2026 updated by: Derma Techno Pakistan

A Prospective Randomized Non-blinded Study of Safety and Efficacy of Bilastine Up-dosing (40 mg) Versus Combination of Bilastine (20 mg) With Levocetrizine (5mg) in the Treatment of Chronic Spontaneous Urticaria

This study aims to compare the effectiveness and safety of two commonly used antihistamines, bilastine 20 mg and levocetirizine 5 mg, in patients diagnosed with chronic urticaria. Chronic urticaria is a skin condition characterized by recurrent itchy wheals that significantly affect quality of life.

Eligible participants will be randomly assigned to receive either bilastine or levocetirizine for a defined treatment period. The severity of symptoms, improvement in itching and wheals, and any adverse effects will be assessed during follow-up visits.

The results of this study will help determine which treatment provides better symptom control with fewer side effects in patients with chronic urticaria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Okāra, Punjab Province, Pakistan, 56300
        • combined military hospital ,Okara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with diagnosis of CSU as per operational definitions.
  • Patients already taking Bilastine 20 mg and still getting new lesions.
  • UAS7 score >3
  • Age range of 18-70 years
  • Both male and female patients

Exclusion Criteria:

  • • women Patients who have already received treatment of CSU other than Bilastine.

    • Patients taking oral or topical corticosteroids
    • Pregnant or lactating
    • Patients with hereditary angioedema, atopic dermatitis, systemic immune disorders, collagen vascular diseases, immunocompromised status, Chronic liver or kidney failures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (tab bilastine 40mg )
patients received oral tab bilastine 20 mg twice daily for 6 weeks
Drug: tab bilastine 20 mg
tab bilastine 20 mg given orally twice a day for 6 weeks
Active Comparator: Group B ( tab bilastine 20 mg + tab levocetrizine 5 mg )
patients received tab bilastine 20 mg in the morning and tab levocitrizine 5 mg in the evening for 6 weeks
Drug: tab bilastine 20 mg + tab levocetrizine 5 mg
tab levocitrizine 5 mg given orally at night with combination of tab bilastine 20 mg in the morning for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in urticaria severity score (UAS7)
Time Frame: baseline to 6 weeks

change in urticaria severity score (UAS7) from baseline to 6 weeks UAS7 is a validated composite score assessing daily wheal number and pruritis severity over 7 consecutive days ,with total scores ranging from 0 to 42.

Higher scores indicate more severe urticaria activity and a reduction in score reflects clinical improvement.
baseline to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Derma Techno Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2025

Primary Completion (Actual)

January 10, 2026

Study Completion (Actual)

January 17, 2026

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IERC/DER/2024/01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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