Treatment Options for Chronic Urticaria

NCT06816784 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: sheikh-ZMCFH
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

chronic urticaria is one of the most common dermatological disease affecting many people, exploring most treatment options for its treatment is need of an hour. Our study aim to compare the efficacy of Autologous Serum Therapy (AST) with levocetirizine in Chronic Urticaria patients

Conditions

Chronic Urticaria

Keywords

chronic urticaria; autologous serum therapy; levocetrizine

Outcome Measures

Primary Outcomes (1)

• COMPARISON OF OUTCOME OF AUTOLOGOUS SERUM THERAPY VS LEVOCETRIZINE IN THE TREATMENT OF CHRONIC URTICARIA

  Efficacy will be assessed clinically at each follow up visit. Final efficacy of each treatment will be determined at last follow up visit( i.e. at 7th week after start of treatment).The final efficacy will be divided into following groups on the basis of clinical resolution of disease: 1. Excellent efficacy: It is defined as greater than 80% reduction in the frequency of urticaria episodes per week as measured from baseline 2. moderate efficacy: It is defined as 50% to less than 80% reduction in number of urticaria episodes per week as measured from baseline healing of urticaria from the baseline. 3.non-efficaceos: It is defined as less than a 50% reduction in the frequency of urticaria episodes per week from baseline.

  Clinical assessment for efficacy will be done monthly for 6 months

Study Arms (2)

Autologous serum therapy group

ACTIVE COMPARATOR

Group A will receive AST 5 ml of blood will be collected and centrifuged at 3000 r.p.m for 10 min to obtain serum,2 ml of the serum will be injected into the gluteus muscle. We will give the patients injection of Autologous Serum intramuscularly once a week for 9weeks

Drug: Autologous serum therapy

levocetirizine group

ACTIVE COMPARATOR

Group B will receive levocetirizine orally 5mg one tablet HS

Drug: Oral levocetirizine

Interventions

Autologous serum therapy DRUG

5 ml of blood will be collected and centrifuged at 3000 r.p.m for 10 min to obtain serum,2 ml of the serum will be injected into the gluteus muscle. We will give the patients 9 injections of Autologous Serum intramuscularly once a week

Autologous serum therapy group

Oral levocetirizine DRUG

Group B will receive oral levocetirizine 5mg 1 tablet HS.

levocetirizine group

Eligibility Criteria

• Age: 13 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age: 13-60 years
• Gender: Both male and female
• Patients having urticaria for more than 6 weeks diagnosed clinically

You may not qualify if:

• Pregnancy and lactating females
• Patients who are immunosuppressed either due to medication or disease.
• Patients suffering from chronic diseases i-e chronic liver disease, chronic kidney disease.
• Patients taking steroids in last 2 weeks.

Sponsors & Collaborators

• Sheikh Zayed Medical College: lead

Study Sites (1)

Sheikh zayed Medical College and Hospital, Rahim Yar Khan, Punjab 644200

Rahim Yar Khan, Punjab Province, 644200, Pakistan

Location

MeSH Terms

Conditions

Chronic Urticaria

Interventions

levocetirizine

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Farah Humera, post graduate resident derma

CONTACT

+923328334251; drfarahumera1@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: post graduate resident indermatology

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 10, 2025
• Study Start: February 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)