To Assess and Compare the Efficacy of Cyclosporine Versus Azathioprine in the Treatment of Chronic Refractory Urticaria

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Fifty six patients of CRU attending the urticaria clinic in the department of Dermatology, Venereology and Leprology at the Post Graduate Institute of Medical Education and Research, Chandigarh will be recruited in the study calculated by using equivalence analysis assuming power of 90%, significance level of 5% and standard deviation of 1 and adjusting 5% of expected drop-outs after taking written informed consent. This study is undertaken with an intention to treat the patients of chronic refractory urticaria completely. Patients will be randomized into two groups A and B using computer generated random number tables, group A will receive Cyclosporine and group B will receive Azathioprine; wherein, 28 random single and double-digit numbers from 1-56 will be selected before recruitment, and patients coming on these numbers will be randomized in a particular group. Random number generation, recruitment and randomization, were all done by the same investigator..

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Azathioprine; Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

• Available definition for chronic refractory urticaria (CRU) is chronic spontaneous urticaria, with disease duration of at least 6 months or above, which is not controlled with four fold increased dosage of antihistamines (as per EAACI guidelines) figure1, given for at least three consecutive months and requiring repeated courses of oral corticosteroids.

Age ≥ 18 years.

Exclusion Criteria:

• Patients giving history of fainting, bronchospasm during previous attacks of urticaria that is suggestive of anaphylaxis.

• Urticaria< 6 weeks.

• Age <18 years.

• Physical and pressure urticaria.

• Urticarial vasculitits.

• Pregnant and lactating patients.

• Cataract, hepatic or renal diseases, severe infections, poorly controlled hypertension

• Concomitant intake of drugs like nephrotoxic drugs (gentamycin, vancomycin, amphotericin-B, indomethacin, diclofenac, H2 antihistamines like ranitidine, cimetidine, phenobarbitone, rifampicin, allupurinol, febuxostat).

• History suggestive of allergy to azathioprine , cyclosporine.

• Absolute contraindications69 of azathioprine are severe infections, severly impaired hepatic or bone marrow function, pancreatitis, live vaccines, pregnancy and lactation.

• Patients with chronic kidney disease, uncontrolled hypertension, renal insufficiency, uncontrolled infections, cutaneous T-cell lymphoma, including mycosis fungoides, should not be given Cyclosporine70.

• Patients who are planning pregnancy.