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IRCT20220904055876N1 IRCT 2022-09-20 Lady Reading Hospital Peshawar Pakistan Tofacitinib and azathioprine in alopecia areata TAA Efficacy and safety of Tofacitinib versus Azathioprine in severe alopecia areata, alopecia universalis and alopecia totalis. 2022-10-04 anticipated 60 Complete https://irct.ir/trial/65702 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method: Block randomization Unit: indiviual Tolls: computer softwares double blinded Randomization will be 1:1 for group A and group B, i.e., each upcoming patient will be included in the next group, Blinding description: participants, care provider, investigator and outcome assessor were blinded. Tablets with same appearance, odor, taste, texture and color but different active substance were used. Only drug manufacturing company was aware of active substance. 3 Alopecia Areata. Patients in group A will receive tofacitinib at 5mg twice daily for 6 months and patients in group B will receive azathioprine in an oral dose of 1-2 mg/kg/day for 6 months. Yes - There is a plan to make this available What will be shared: Efficacy and safety of Tofacitinib versus Azathioprine in severe alopecia areata, alopecia universalis and alopecia totalis. When: 6 months after publication To whom: for people working in academic institutions Conditions: no criteria Where to obtain: contact via email provided previously How to obtain: no process involved Comments: none
public Farah Sagheer
Lady Reading Hospital, Peshawar, Pakistan
Peshawar Pakistan 45666 +92 321 9049707 farah.sagheer@lrh.edu.pk Lady Reading Hospital Peshawar Pakistan scientific Farah Sagheer
Lady Reading Hospital, Peshawar, Pakistan
Peshawar Pakistan 45666 +92 321 9049707 farah.sagheer@lrh.edu.pk Lady Reading Hospital Peshawar Pakistan Pakistan Patients having Alopecia areata with ≥50% scalp hair loss, Alopecia totalis and Alopecia universalis. Patients must not have received any treatments for Alopecia areata within 2 months of enrollment and will not permitted to use any other treatment known to affect AA Stable or worsening disease for ≥6 months 12 years 60 years Both Active malignancy or a history of malignancy Leukopenia, Anemia Hepatic or renal impairment Human immunodeficiency virus, Hepatitis B and C. Pregnant or nursing women L63 Alopecia areata Treatment - Drugs Patients in group A will receive tofacitinib at 5mg twice daily for 6 months and patients in group B will receive azathioprine in an oral dose of 1-2 mg/kg/day for 6 months Severity of Alopecia Tool (SALT) score. Treatment will be considered efficacious if percent change in SALT score is > 50%. Timepoint: before intervention and 3 months and 6 months after intervention. Method of measurement: Severity of Alopecia Tool (SALT) score. Lady Reading Hospital Peshawar Pakistan Approved 2022-08-10 Ethics committee of Lady Reading Hospital Peshawar Dermatology Department, Lady Reading Hospital Peshawar, Pakistan. Peshawar Khyber Pukhtunkhwa Pakistan