Health Condition 1: L80- Vitiligo
Conditions
Interventions
Intervention1: Topical Tofacitinib 2% ointment: Topical tofacitinib 2% ointment applied to vitiligo patches twice a day for 16 weeks
Control Intervention1: Topical Tacrolimus 0.1% ointment: Topical Ta
Sponsors
Post Graduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients reporting that their vitiligo is either ‘a lot less noticeable’ or ‘no longer noticeable’ in response to the question: ‘Compared with the start of the study, how noticeable is the vitiligo now? using the validated Vitiligo Noticeability Scale (VNS).Timepoint: 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Onset of treatment response: assessed by participant & investigator for each patch of vitiligo. The question ‘Compared with the start of the study, has there been a change in the vitiligo patch?’ is asked, with the patient & investigator responding with one of the following: stayed the same, improved, got worse.Timepoint: week 4, week 8, week 12 & week 16;Repigmentation in each topographical area will be assessed by using Vitiligo Area Scoring Index (VASI) at every visitTimepoint: week 4, week 8, week 12 & week 16;Colour-match of Repigmentation: Somewhat Darker/Somewhat Lighter/Same Timepoint: week 4, week 8, week 12 & week 16;Pattern of repigmentation: Diffuse/Peri-follicular/Peripheral/Combined Timepoint: week 4, week 8, week 12 & week 16;Incidence of adverse effectsTimepoint: week 4, week 8, week 12 & week 16 | — |
Countries
India
Contacts
Public ContactDavinder Parsad
Post Graduate Institute of Medical Education and Research
Outcome results
None listed