To evaluate the efficacy of long-term treatment with tacrolimus ointment in patients with vitiligo.

A total of 156 patients with vitiligo (70 males and 86 females) were enrolled into this study, who were firstly diagnosed with vitiligo and continuously followed up in Department of Dermatology, Yiwu Dermatology Hospital and the Third People′s Hospital of Hangzhou between January 2016 and February 2018. Of the 156 patients, 114 were adults, and 42 were children aged 6 - 18 years. All the patients received 6-month treatment with tacrolimus ointment twice a day. They were followed up once a month, the time to initial repigmentation and vitiligo area severity index (VASI) were recorded, and VASI improvement rate was calculated. After 6-month treatment, the patients achieving marked improvement were divided into conventional treatment group and interval treatment group to be treated with tacrolimus ointment twice a day and once every 3 days respectively for another 6 months, and final efficacy of the 2 protocols was compared. Mauchly′s test of sphericity, randomized block analysis of variance and Bonferroni method were used to analyze differences among pre-treatment VASI scores, and 1- to 6-month post-treatment VASI scores.

Among the 156 patients, the pre-treatment, and 1-, 2-, 3-, 4-, 5- and 6-month post-treatment VASI scores[M (P25, P75) ] were 2 (0.6, 5) , 2 (2, 5) , 1.6 (0.575, 4.5) , 1.2 (0.5, 4.0) , 0.4 (1.15, 3.5) , 0.75 (0.3, 2.575) , 0.6 (0.2, 2.2) respectively. Additionally, there was a significant difference in the VASI score among the above time points (F = 6.14, P < 0.05) , and the VASI score showed a gradual decreasing trend over time. During the initial 6-month treatment, the average time to initial repigmentation was 2.2 ± 0.6 months. Of the 156 patients, 98 (62.8%) received marked improvement, and the time to marked improvement was 5.2 ± 0.6 months. Of the 98 patients who received marked improvement, 46 completed another 6-month treatment. After 12-month treatment, there was no significant difference in the repigmentation rate between the conventional treatment group (73.3% ± 18.2%) and interval treatment group (72.0% ± 16.2%, t = 0.42, P > 0.05) .

The initial 6-month topical tacrolimus therapy showed marked efficacy for vitiligo. After the marked improvement of skin lesions, good efficacy can be maintained by long-term treatment with topical tacrolimus once every 3 days or twice a day.

Vitiligo; Therapy; Tacrolimus; Long-term treatment