Combination of tofacitinib with transplantation of non-cultured epidermal cellsuspension vs non-cultured epidermal cellsuspension alone in non-segmental vitiligo clinically stable for less than 1 year: a randomized controlled trial - NI

All India Institute of Medical Sciences0 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.Adult (18-65 years) patients with non-segmental (generalized, acrofacial, focal) slowly progressive vitiligo or clinically stable for less than 1 year (0-9 months)
•2.Vitiligo patch of size 2.5-25 cm2, that is unresponsive or partially responsive to medical treatment x more than 3 months

•1.Patients with segmental vitiligo
•2.Patients with vitiligo of clinical disease stability more than 1 year
•3.Patients with rapidly progressive vitiligo (more than 5 patches in the last one month and/or more than 15 patches in last 3 months)
•4.Patients with keloidal or bleeding tendency
•5.Patients on topical treatment for last 2 weeks, and on phototherapy or systemic treatment for last 4 weeks
•6.Patients with concomitant inflammatory skin diseases or autoimmune diseases requiring systemic immunosuppressive treatment
•7.Patients with active or latent tuberculosis or other systemic infection or any other contra-indication to tofacitinib (as per investigators judgement)
•8.Children, adults (more than 65 years), pregnant or lactating women with vitiligo
•9.Women of child bearing potential not willing to observe sexual abstinence or use contraceptive during the period of oral treatment and 6 weeks beyond
•10.Vitiligo patch less than 2.5cm2 or more than 25cm2 size
•11.Patches on sites such as palms, soles, fingers and toes

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