Health Condition 1: L501- Idiopathic urticaria
Conditions
Interventions
Intervention1: NB-UVB phototherapy: For NB-UVB phototherapy, cabins containing fluorescent TL - 01 (100 W) tubes will be used as the source of irradiation. Therapy will be empirically started with 280
Sponsors
PGIMER, Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: Patients of chronic refractory urticaria. In the absence of any available definition for chronic refractory urticaria (CRU), it is arbitrarily defined as - chronic spontaneous urticaria, with disease duration of at least 6 months or above, which is not controlled with standard dosing schedules of antihistamines, given for at least three consecutive months, thus requiring immunosuppressive and immunomodulatory therapy.
Exclusion criteria
Exclusion criteria: 1. Patients giving history of fainting, bronchospasm during previous attacks of urticaria that is suggestive of anaphylaxis. 2. Urticaria 3. Age 4. Patients with inducible urticaria. 5. Urticarial vasculitits. 6. Pregnant and lactating patients. 7. Patients having history of photosensitivity or photosensitive disorders. 8. Patients with pemphigus and bullous pemphigoid. 9. Cataract, hepatic or renal diseases. 10. Concomitant intake of phototoxic drugs like doxycycline etc. 11. History suggestive of allergy to cyclosporine 12. Patients with chronic kidney disease, uncontrolled hypertension, renal insufficiency, uncontrolled infections, cutaneous T-cell lymphoma, including mycosis fungoides, should not be given cyclosporine44. 13. Concomitant intake of drugs like nephrotoxic drugs (gentamycin, vancomycin, amphotericin-B, indomethacin, diclofenac, H2 antihistamines like ranitidine, cimetidine, phenobarbitone, rifampicin, allupurinol, febuxostat). 14. Patients planning pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The end point / primary efficacy parameter is defined as â?¥ 75% reduction in UAS7 with the treatment.Timepoint: at the end of treatment period(3 months) and at the end of follow-up(6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the effect of phototherapy and cyclosporine on IL-6, IL-31, ASST and serum IgE levels. To study the relationship of IL-6 and IL-31 levels to the baseline disease severity. Timepoint: at the beginning of treatment and at the end of treatment period(3 months) | — |
Countries
India
Contacts
Public ContactRoshini N
Post Graduate Institute of Medical Education and Research
Outcome results
None listed