Efficacy of Bilastine Up-dosing (40 mg ) Versus Combination of Bilastine (20 mg )With Levocitirizine (5 mg) 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.

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Key information

Conditions

Chronic Spontaneous Urticaria (CSU) Chronic Disease Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

combined military hospital ,Okara

Okāra, Punjab Province, 56300, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tab bilastine 20 mg

Drug

tab bilastine 20 mg given orally twice a day for 6 weeks

tab bilastine 20 mg + tab levocetrizine 5 mg

Drug

tab levocitrizine 5 mg given orally at night with combination of tab bilastine 20 mg in the morning for 6 weeks

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Derma Techno Pakistan

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jan 26, 2026
Registry last updated: Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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