Comparing Tofacitinib and Tacrolimus Creams for Unstable Vitiligo Treatment
- Conditions
- Vitiligo,
- Registration Number
- CTRI/2023/12/060431
- Lead Sponsor
- Post Graduate Institute of Medical Education and Research
- Brief Summary
Vitiligo is the commonest depigmenting skin disorder affecting people of all skin types and ethnicities. It is characterized by a selective and progressive loss of functioning melanocytes from epidermis resulting in white patches on the skin and occasionally mucosae as well. A number of treatment approaches have been tried but none of them has been universally accepted as the therapy of choice. Currently there is no cure or effective method to limit the spread of the disease. The topical calcineurin inhibitors tacrolimus (0.03% in children and 0.1% in adults) and pimecrolimus 1% are preferred to topical corticosteroids for patients with limited vitiligo involving the face or areas at high risk for skin atrophy (e.g., intertriginous areas, genitals). Individual case reports describing the efficacy and safety of topical JAKi including topical tofacitinib, topical ruxolitinib and topical brepocitinib are available. These have been tried in cases of segmental as well as non-segmental vitiligo. While topical tofacitinib and ruxolitinib had favorable outcomes, topical delgocitinib showed variable results.Most of the studies on topical JAKi in vitiligo are open label, uncontrolled studies in whom treatment has been tried in combination with other therapies. Larger randomized trials are needed to conclusively establish role of topical JAKi in management of vitiligo.
In this prospective randomised study, we intend to evaluate the efficacy and tolerability of topical tofacitinib and compare it with topical tacrolimus in 25 patients (50 patches) of limited vitiligo vulgaris with an actively spreading disease and satisfying other inclusion criterias.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
- Consecutive patients with clinical diagnosis of vitiligo vulgaris and fulfilling the inclusion criteria listed below will be recruited for the study.
- 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).
- 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).
- Participants also need to be willing and able to give informed consent (or parental/guardian consent in the case of children).
- 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.
- 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.
- 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). 16 weeks
- Secondary Outcome Measures
Name Time Method 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. 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 visit week 4, week 8, week 12 & week 16 Colour-match of Repigmentation: Somewhat Darker/Somewhat Lighter/Same Pattern of repigmentation: Diffuse/Peri-follicular/Peripheral/Combined Incidence of adverse effects week 4, week 8, week 12 & week 16
Trial Locations
- Locations (1)
Post Graduate Institute of Medical Education and Research, Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
Post Graduate Institute of Medical Education and Research, Chandigarh🇮🇳Chandigarh, CHANDIGARH, IndiaDr Davinder ParsadPrincipal investigator7986359284parsad@mac.com