Evaluation of efficacy and safety of Tofacitinib, a Janus kinase inhibitor in patient with moderate to severe Atopic dermatitis: A randomized, double-blind, placebo-controlled trial - NI

AIIMS Bhubaneswar0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•1.Patient age =18 years and =75 years of either sex with a clinical diagnosis of chronic atopic dermatitis (according to Hanfin and Rajka criteria)
•2.Patient with Eczema Area and Severity Index (EASI) score =16 at the baseline visit.
•3.Investigator Global Assessment score =3 (scale of 0 to 4) at the baseline visit.
•4.Body surface Area =10% involvement in AD at baseline visit.
•5.Peak pruritus-Numerical rating scale scoring of =4 at baseline visit.
•6.History of insufficient response to topical treatments or medical contraindication to topical therapy.
•7.Patients who are willing to give informed written consent.

•1.History of treatment with any JAK inhibitor.
•2.Treatment with calcineurin inhibitor, or phosphodiesterase 4 inhibitors within 1 week of baseline visit.
•3.Current treatment with topical or oral tofacitinib.
•4.Treatment with systemic corticosteroid within the last 4 weeks.
•5.Patient on any immunosuppressive agent such as azathioprine, cyclosporine, and Biologic DMARDs like infliximab, etanercept, adalimumab, or rituximab within one month of recruitment.
•6.Phototherapy treatment within the last 4 weeks of baseline visit.

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