Effectiveness of topical tofacitinib 2 percent ointment versus placebo with whole- body phototherapy in patients with non-segmental vitiligo: A split-body study

Vitiligo is an acquired depigmentary disorder characterized by loss of melanocytes. Few studies have already shown that combination treatment is often superior as compared to monotherapy in the treatment of vitiligo. Oral and topical JAK inhibitors like tofacitinib have been found to be beneficial when used in combination with whole-body phototherapy. Combination treatment has been shown to produce a better extent of repigmentation as compared to monotherapy alone. Combination treatments are often considered superior to monotherapy. Recent studies have identified Janus kinase (JAK) inhibitors, such as oral and topical tofacitinib, as promising agents targeting the underlying immune dysregulation in vitiligo. Tofacitinib blocks JAK pathways involved in the pathogenesis of vitiligo, potentially promoting repigmentation when combined with phototherapy. However, existing clinical data on the combination therapy efficacy and safety is limited, particularly from well-controlled studies. There are a few studies showing a combination of oral JAK inhibitors with phototherapy superior to either monotherapy, and some case reports showing a combination of topical JAK inhibitors with phototherapy producing good repigmentation in patients with vitiligo. However, there are no studies that have compared the combination of topical JAK inhibitor (tofacitinib 2%) with whole body NB-UVB phototherapy to the combination of placebo with whole body NB-UVB phototherapy in patients with non-segmental vitiligo. In this study, we aim to compare the effectiveness of topical tofacitinib 2% ointment versus placebo with whole-body phototherapy in patients with non-segmental vitiligo. The findings from this study will help us to determine whether using topical tofacitinib along with phototherapy significantly improves treatment outcomes over phototherapy alone or not. By using a split-body design, this study minimizes inter-patient variability, allowing for a more precise evaluation of tofacitinib’s additive benefit in repigmentation.