‘Ruxolitinib cream for the treatment of vitiligo: a randomised, controlled, phase 2 trial': a critical appraisal

Funding sources: none. Conflicts of interest: The authors declare they have no conflicts of interest. Vitiligo is an acquired condition that presents as cutaneous depigmentation.1 There is no licensed treatment for the repigmentation of vitiligo lesions; however, several therapies are used routinely and have been studied in clinical trials, including topical corticosteroids, calcineurin inhibitors and phototherapy.1 In 2019 the International Initiative for Outcomes for Vitiligo (INFO) recommended standard clinical outcome measures be used when conducting trials of interventions for vitiligo: repigmentation; adverse events; and preservation of repigmentation effect.2 Rosmarin et al. report results from a randomized controlled trial (RCT) reviewing the therapeutic efficacy and safety of ruxolitinib cream in the treatment of vitiligo.3 This study had three parts and was carried out over 156 weeks. In the first part, participants were randomly assigned (1 : 1 : 1 : 1 : 1) to ruxolitinib cream (1·5% twice daily, 1·5% daily, 0·5% daily or 0·15% daily) or vehicle (control group) twice daily. In the second part, patients in the control group and ruxolitinib 0·15% daily who did not achieve a Facial Vitiligo Area Scoring Index (F‐VASI) of 25% were randomly allocated to one of the three ruxolitinib groups until week 52. In the third, open‐label, part, ruxolitinib cream 1·5% twice daily could be used for 104 weeks, with discretional phototherapy.