Chronic Idiopathic Urticaria
Conditions
Keywords
chronic idiopathic urticaria, antihistamines, desloratadine, autologous serum skin test, autologous whole blood therpy
Brief summary
To evaluate the efficacy of Autologous Whole Blood Therapy versus conventional treatment using fourfold dose of antihistamines in Autologus serum skin test (ASST) positive and negative Chronic Idiopathic Urticaria (CIU) patients and suggest its possible mechanism of action.
Detailed description
To evaluate the efficacy of Autologous Whole Blood Therapy (AWBT) versus conventional treatment using fourfold dose of antihistamines in ASST positive and negative Chronic Idiopathic Urticaria (CIU) patients and suggest its possible mechanism of action. Also, assessment of serum levels of D-dimer, IFN-γ, IL-6, anti-IgE IgG before and after treatment. All patients will take desloratadine 10 mg at four-fold dose daily The AWBT test group patients will receive 8 doses of autologous whole blood therapy (AWBT) once weekly. The first dose will be 2.5ml and subsequent doses will be 5ml of venous blood, which will be drawn from any accessible vein under aseptic precautions. The blood will be re-injected immediately by deep intramuscular injection (IM) on alternate gluteal regions. Patients will be advised to record the 7-day urticaria activity score (UAS 7) based on a simple questionnaire, on day 0, 4th week and 8th week of the treatment (End of Therapy (EOT)), and in the follow up period after 4 weeks following EOT (End of Study (EOS)). Dermatology life quality index (DLQI) will be assessed before treatment and at the end of therapy (8 weeks).
Interventions
BIOLOGICALAutologous whole blood therapy
The AWBT test group patients will receive 8 doses of autologous whole blood therapy (AWBT) once weekly. The first dose will be 2.5ml and subsequent doses will be 5ml of venous blood, which will be drawn from any accessible vein under aseptic precautions. The blood will be re-injected immediately by deep intramuscular injection (IM) on alternate gluteal regions.
DRUGDesloratadine
All patients will take desloratadine 10 mg at four-fold dose daily
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Chronic idiopathic urticaria patients of both sexes aging 18 years of age or older who are unresponsive to four-fold of antihistamines.
Exclusion criteria
1. other types of chronic urticaria 2. Pregnancy 3. Lactation 4. Immunocompromised patients 5. Patients on Systemic corticosteroid or immunosuppressive drugs used in the past 6 weeks 6. History of Bronchial Asthma 7. Patients on anticoagulants 8. Patients on non-steroidal anti-inflammatory drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in urticaria activity score (UAS7) from baseline to 8 weeks | 12 months | Change in 7-day urticaria activity score (UAS7) score from baseline to 8 weeks after treatment with either AWBT with fourfold antihistamines or fourfold of antihistamines alone in Chronic Idiopathic Urticaria (CIU) patients. urticaria activity score7 ranges from 0-42. A score of 0 means complete remission while score (28-42) means severe disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| correlation between ASST result and treatment response | 12 months | correlation between autologous serum skin test (ASST) result (positive/negative) and change in UAS7 score after 8 weeks of treatment. ASST positivity will be assessed as a binary variable(positive/negative), and treatment response will be measured as the change in UAS7 |
| correlation between serum biomarkers and treatment response | 12 months | correlation between baseline serum levels of interferon-gamma (IFN-γ), interleukin-6(IL-6) and anti-IgE IgG antibodies and change in UAS7 score after 8 weeks of treatment. serum biomarkers will be measured using ELISA and expressed in pg/ml (for IFN-γ, IL-6) and optical density or concentration units for anti-IgE IgG. |
Countries
Egypt
Contacts
CONTACTSarah Elsayed, MSc, MBBCh
CONTACTAhmed Mourad, MD
Outcome results
None listed