An open label, non-randomized, interventional study to evaluate the efficacy and safety of microneedling combined with 5-fluorouracil 5% cream versus microneedling combined with tacrolimus 0.1% ointment versus microneedling alone in clinically stable vitiligo patients

Abstract

Background: Vitiligo is a chronic, acquired depigmentation disorder characterized by the selective destruction of melanocytes, leading to the appearance of white macules on the skin. It affects approximately 0.5% to 2% of the global population and has a profound psychosocial impact despite its non-life-threatening nature. Various treatment modalities exist, including topical immunosuppressants, phototherapy, and surgical interventions, but none guarantee universal efficacy. Microneedling has emerged as a promising approach to enhance repigmentation, particularly when combined with pharmacological agents such as 5-Fluorouracil (5-FU) and Tacrolimus. However, limited comparative studies exist evaluating the efficacy and safety of these combinations in stable vitiligo. Aim and Objective: The primary objective of this study is to compare the efficacy of microneedling alone versus microneedling combined with 5-FU 5% cream and microneedling combined with Tacrolimus 0.1% ointment in patients with stable vitiligo. The secondary objective is to assess the safety profile and patient satisfaction associated with these treatment modalities.