Treatment Options for Chronic Urticaria

Sheikh Zayed Medical College

Status and phase: Not yet enrolling; Phase 2

Conditions: Chronic Urticaria

Treatments: Drug: Oral levocetirizine; Drug: Autologous serum therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06816784

sheikh-ZMCFH

Details and patient eligibility

About

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

Full 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

Enrollment: 72 estimated patients

Sex: All

Ages: 13 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Autologous serum therapy group

Active Comparator group

Description:

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

Treatment:

Drug: Autologous serum therapy

levocetirizine group

Active Comparator group

Description:

Group B will receive levocetirizine orally 5mg one tablet HS

Treatment:

Drug: Oral levocetirizine