Efficacy of Topical 5% 5-Fluorouracil with Needling versus 5% 5-Fluorouracil Alone in Stable Vitiligo: A Randomized Controlled Study.

BACKGROUND: Vitiligo is a chronic disease of great cosmetic concern presenting with depigmented macules and patches. It is often recalcitrant to medical treatment. AIM: The aim of the study was to study the efficacy and safety of topical 5% 5-fluorouracil with needling versus topical 5% 5-fluorouracil alone in stable vitiligo. MATERIALS AND METHODS: This interventional prospective study was conducted from July 2018 to June 2019. Total of 60 patients, with stable vitiligo of age older than 10 years, were randomly assigned into two groups of 30 patients each. Group A was treated with needling followed by topical 5% 5-fluorouracil over vitiligo patches. The procedure was performed every 2 weeks for 3 months. Group B was treated with topical 5% 5-fluorouracil alone. Clinical improvement was assessed monthly till 6 months by serial clinical photographs and grading score. RESULTS: Initiation of repigmentation started at 1 month in 76 patches (65%) in Group A, whereas in group B, it was seen in 45 patches (38.7%), which was statistically significant (P = 0.0001). Excellent improvement (>75% repigmentation) was noted in 55 patches (47%) in Group A as compared to 5 patches (4.3%) in group B at the end of 6 months (P = 0.03). CONCLUSION: Needling with 5% 5-fluorouracil appears to be simple, safe, and effective treatment in vitiligo. It can be used in poor responders to conventional therapy.