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Treatment Options for Chronic Urticaria

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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06816784
Enrollment
72
Registered
2025-02-10
Start date
2025-02-28
Completion date
2025-07-31
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Urticaria

Keywords

chronic urticaria, autologous serum therapy, levocetrizine

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

Interventions

DRUGAutologous 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

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

Sponsors

Sheikh Zayed Medical College
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
COMPARISON OF OUTCOME OF AUTOLOGOUS SERUM THERAPY VS LEVOCETRIZINE IN THE TREATMENT OF CHRONIC URTICARIAClinical assessment for efficacy will be done monthly for 6 monthsEfficacy 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.

Countries

Pakistan

Contacts

Primary ContactFarah Humera, post graduate resident derma
drfarahumera1@gmail.com+923328334251

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026