MedPath

Effect of bepotastine besilate and levocetrizine in urticaria disease of ski

Phase 3
Completed
Conditions
Health Condition 1: L500- Allergic urticariaHealth Condition 2: null- diagnosis of CSU (EAACI), characterized by erythematous skin wheals accompanied by itching of unknown etiology will be recruited.
Registration Number
CTRI/2017/10/010232
Lead Sponsor
Dr E Gayathri
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
100
Inclusion Criteria

Male and female patients, aged 18-70 years old, with a diagnosis of CSU (EAACI), characterized by erythematous skin wheals accompanied by itching of unknown etiology will be recruited.

Eligible patients should demonstrate Symptom score of >=2 (i.e. moderate to severe intensity UAS7 scores) during the baseline visit.

Patients willing to give informed consent will be included.

Exclusion Criteria

Patients excluded from the study if they have any dermatological condition that could interfere with the efficacy evaluation (including eczema, contact dermatitis, atopic dermatitis, nummular eczema, autosensitization dermatitis, asteatotic eczema, lichen simplex chronicus, angioedema, , urticaria with known causes, urticaria related to thyroid disorders, urticaria pigmentosa, psoriasis, or ichthyosis

o Known hypersensitivity to antihistamine,

oKnown autoimmune disorders, Hodgkins disease

oAny clinically significant condition (cardiovascular, neurological, hepatic, renal, or malignant diseases),

oReceived ultraviolet light therapy before entry.

oSimilarly, patients who had received antihistamines (including H2 receptor antagonists) within 3 days, nonsteroidal anti-inflammatory drugs within 3 days, topical or systemic steroids within 4 weeks, astemizole within 6 weeks, ketotifen within 2 weeks, anti-Leukotrienes within 3 days.

oPregnant and lactating women.

oSubject who is currently enrolled in another investigational drug study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath