Efficacy of the Topical Calcineurin Inhibitors Tacrolimus and Pimecrolimus in the Treatment of Vitiligo in Infants Under 2 Years of Age: A Randomized, Open-Label Pilot Study
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The efficacy of topical calcineurin inhibitors (TCIs) for the treatment of infants with vitiligo aged less than 2 years remains to be fully determined.
This aim of this pilot study was to assess the efficacy and tolerability of the TCIs tacrolimus and pimecrolimus in infants with vitiligo aged under 2 years.
Infants with vitiligo aged < 2 years were randomly assigned to receive either tacrolimus ointment 0.03% or pimecrolimus cream 1% for a period of 6 months. During this period, topical treatment was applied twice daily. The proportion of body surface area of the treated lesions, locations, and possible adverse effects were recorded. In addition, the overall satisfaction scores of the patients’ parents was evaluated by virtue of the visual analog scale (VAS).
Forty-six infants with vitiligo were enrolled in this study. The overall response rate (> 0% repigmentation) was 100%, while the effective rate (> 50% repigmentation) of the tacrolimus and pimecrolimus groups was 69.6% and 65.2%, respectively. Meanwhile, the effective rates for vitiligo located on the head and neck, trunk, and extremities were 70%, 64.3% and 50%, respectively, while the response rates for non-segmental and segmental vitiligo were 74.4% and 28.6%, respectively. Only a low incidence of local adverse reactions (including mild redness and skin picking) was reported during the treatment process.
Topical tacrolimus ointment 0.03% or pimecrolimus cream 1% have efficacy for vitiligo in infants, which serves to achieve an appropriate level of safety and tolerability during the 6-month period of applications. Thus, TCIs proved to be a therapeutic option for vitiligo in infants under 2 years of age.
Compliance with Ethical Standards
This study was funded by the Science and Technology Bureau of Yiwu (17-1-29 and 17-1-30), the National Natural Science Foundation of China (81472887, 81773335, and 81602755), the Basic Public Welfare Research Project of Zhejiang Province (LGF18H110002), and the Natural Science Foundation of Zhejiang Province (LY18H110002).
Conflict of interest
Wenting Hu and Yongping Xu contributed equally to this work. Wenting Hu, Yongping Xu, Yangyang Ma, Jiehao Lei, Fuquan Lin, and Ai-E Xu declare they have no competing interests.
All procedures performed in studies involving human participants were in accordance with the study protocol, the Ministerial Ordinance on GCP for Drugs, and the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study protocol was approved by the Institutional Review Board at Anhui University Hospital on 12 February 2016.
Informed consent was obtained from parents of all individual participants included in this study.