A randomized study to compare the efficacy of topical tofacitinib versus topical tacrolimus in treatment of patients with unstable vitiligo - Nil

Post Graduate Institute of Medical Education and Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

试验速览

暂无简介。

•Consecutive patients with clinical diagnosis of vitiligo vulgaris and fulfilling the inclusion criteria listed below will be recruited for the study.
•1. Participants aged 5 years and over with a diagnosis of non-segmental vitiligo, limited to approximately 10% or less of body surface area
•2. At least two symmetrical vitiligo patches that have been active in the last 12 months (reported by the participant, or parent).
•3. Participants should be willing to stop any other active therapies for their vitiligo at time of randomisation, be able to administer the treatments safely at home (able to follow the treatment instructions and children able to comply with the necessary precautions).
•4. Participants also need to be willing and able to give informed consent (or parental/guardian consent in the case of children).

•1. Potential participants with segmental or universal vitiligo, vitiligo limited to areas contraindicated for treatment with potent topical corticosteroid (e.g., around the genitals)
•2. Evidence of marked Koebner phenomenon (lesions appearing in sites of skin trauma) as such potential participants are likely to require urgent care.
•3. Participants with a history of skin cancer, radiotherapy use or photosensitivity;
•4. Women who are pregnant, breastfeeding or likely to become pregnant during the treatment period;
•5. Those currently using immunosuppressive drugs, or involved in another clinical trial and those with allergy or contraindication to any of the drugs.
•6. Potential participants are not randomised into the trial if the investigator feels that they are unable to follow the treatment instructions, or if children are unable to comply with the necessary safety precautions.
•Patients receiving topical or systemic therapy of any form for vitiligo will be kept off treatment for 2 weeks prior to start of therapy (as a wash out period).

发起方

Post Graduate Institute of Medical Education and Research