Treatment Options for Chronic Urticaria

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Urticaria
• Intervention / Treatment: Drug: Autologous serum therapy; Drug: Oral levocetirizine

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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Farah Humera, post graduate resident derma; Phone Number: +923328334251; Email: drfarahumera1@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Rahim Yar Khan, Punjab, Pakistan, 644200
      • Sheikh zayed Medical College and Hospital, Rahim Yar Khan, Punjab 644200
      • Contact: Sheikh zayed Medical college rahim yar khan ounjab; Phone Number: +92689230168; Email: info@szmc.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Autologous serum therapy group; 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; 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
Active Comparator: levocetirizine group; Group B will receive levocetirizine orally 5mg one tablet HS	Drug: Oral levocetirizine; Group B will receive oral levocetirizine 5mg 1 tablet HS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sheikh Zayed Medical College

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: levocetrizine; chronic urticaria; autologous serum therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Vascular; Chronic Urticaria; Urticaria; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Histamine H1 Antagonists; Histamine H1 Antagonists, Non-Sedating; Levocetirizine
• Other Study ID Numbers: sheikh-ZMCFH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No