Comparing Tofacitinib and Tacrolimus Creams for Unstable Vitiligo Treatment

Phase 4

Conditions: Health Condition 1: L80- Vitiligo

Registration Number: CTRI/2023/12/060431

Lead Sponsor: Post Graduate Institute of Medical Education and Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Colour-match of Repigmentation: Somewhat Darker/Somewhat Lighter/Same <br/ ><br>Timepoint: week 4, week 8, week 12 & week 16;Incidence of adverse effectsTimepoint: week 4, week 8, week 12 & week 16;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;Pattern of repigmentation: Diffuse/Peri-follicular/Peripheral/Combined <br/ ><br>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