Treatment Options for Chronic Urticaria

Phase 2

Not yet recruiting

• Conditions: Chronic Urticaria
• Interventions: Drug: Autologous serum therapy; Drug: Oral levocetirizine

• Registration Number: NCT06816784
• Lead Sponsor: Sheikh Zayed Medical College

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

Detailed Description

Urticaria is one of the most common skin diseases causing redness, and swelling in the dermis and epidermal layers and are severely pruritic.

Chronic urticaria is further sub-divided into chronic spontaneous urticaria and chronic inducible urticaria. International guidelines recommend non-sedating antihistamines once daily as first-line therapy for chronic spontaneous urticaria and chronic inducible urticaria.

Levocetirizine which is classified as a second-generation antihistamine and works by blocking histamine H1-receptors , is an effective treatment for CIU, characterized not only by a rapid and sustained response, but also by an important improvement in QOL.

Autologous serum therapy (AST) has been tried by many in patients with CAU with variable results, majority showing beneficial effects. AST has also been used in the treatment of ocular alkali burn patients Presence of tolerance generating anti-idiotype antibodies to mast cell degranulating antigens that induce remission of the disease forms the basis of AST and this therapy has been tried in various autoimmune diseases Our study aim to compare the efficacy of Autologous Serum Therapy (AST) with levocetirizine in Chronic Urticaria patients OBJECTIVE "TO COMPARE THE EFFICACY OF AUTOLOGOUS SERUM THERAPY VS LEVOCETRIZINE IN THE TREATMENT OF CHRONIC URTICARIA IN TERTIARY CARE HOSPITAL"

DATA COLLECTION:

Data will be collected on prescribed proforma which is attached, at Dermatology OPD, Sheikh Zayed Hospital, Rahim Yar Khan. Patient will be selected on basis of inclusion \& exclusion criteria. Informed consent will be taken from selected patients before data collection. Study will include 72 patients which will be divided into 2 groups, A \& B, 36 in each group. Group A will receive AST, Group B will receive oral levocetirizine 5mg 1 tablet HS.

5 ml of blood will be collected and centrifuged at 3000 RPM 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 .

Follow up visit will be after 2 months of last session.

DATA ANALYSIS:

Data will be analyzed by SPSS v25.0

Study Timeline

• Study First Submitted: 2025-01-21
• Status Verified: 2025-02
• Study Start: 2025-02
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous serum therapy group	Autologous serum therapy	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
levocetirizine group	Oral levocetirizine	Group B will receive levocetirizine orally 5mg one tablet HS

Primary Outcome Measures

Name	Time	Method
COMPARISON OF OUTCOME OF AUTOLOGOUS SERUM THERAPY VS LEVOCETRIZINE IN THE TREATMENT OF CHRONIC URTICARIA	Clinical assessment for efficacy will be done monthly for 6 months	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.

Trial Locations

Locations (1)

Sheikh zayed Medical College and Hospital, Rahim Yar Khan, Punjab 644200; 🇵🇰 Rahim Yar Khan, Punjab, Pakistan