Efficacy and safety of crisaborole ointment combined with 308-nm excimer laser in the treatment of non-segmental vitiligo: a randomized, intra-patient left-right controlled study protocol

BACKGROUND: Non-segmental vitiligo is an autoimmune disorder causing melanocyte loss and depigmentation. The 308-nm excimer laser is effective but achieving sustained repigmentation is challenging. Crisaborole, a PDE-4 inhibitor, may synergize with laser therapy. This study evaluates crisaborole 2% ointment plus laser vs. laser monotherapy with vehicle using an intra-patient left-right controlled design. METHODS: This is a single-center, randomized, double-blind, intra-patient controlled trial. Eligible adults (18-65 years) with stable NSV and at least two comparable symmetrical lesions will be enrolled. Lesions will be randomly assigned to receive either crisaborole + 308-nm excimer laser or vehicle + 308-nm excimer laser. Laser treatment will be administered twice weekly, and ointments applied twice daily over 24 weeks. The primary endpoint is the proportion of lesions achieving ≥75% improvement in the Vitiligo Area Scoring Index (VASI/F-VASI) at the end of treatment. Secondary endpoints include mean percentage change in VASI/F-VASI, time to first repigmentation, recurrence at three months post-treatment, and patient-reported satisfaction. Adverse events will be monitored throughout the study. CONCLUSION: This trial aims to provide high-quality evidence regarding the potential synergistic effect of crisaborole combined with excimer laser therapy, potentially establishing a more effective and safe treatment option for NSV. CLINICAL TRIAL NUMBER: ChiCTR2600124948.