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

Derma Techno Pakistan

Status: Completed

Conditions: Chronic Spontaneous Urticaria (CSU)

Treatments: Drug: tab bilastine 20 mg; Drug: tab bilastine 20 mg + tab levocetrizine 5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT07365683

IERC/DER/2024/01

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group A (tab bilastine 40mg )

Active Comparator group

Description:

patients received oral tab bilastine 20 mg twice daily for 6 weeks

Treatment:

Drug: tab bilastine 20 mg

Group B ( tab bilastine 20 mg + tab levocetrizine 5 mg )

Active Comparator group

Description:

patients received tab bilastine 20 mg in the morning and tab levocitrizine 5 mg in the evening for 6 weeks

Treatment:

Drug: tab bilastine 20 mg + tab levocetrizine 5 mg