Abstract
Background
Tacrolimus ointment is a recently developed topical immunomodulator that has been approved for use in patients with vitiligo older than 2 years. Concern regarding potential systemic toxic effects has limited treatment options for children younger than 2 years. We wanted to determine whether topical tacrolimus therapy is safe and effective in patients with vitiligo younger than 2 years.
Methods
The present 6-month clinical trial was conducted to evaluate the efficacy and safety of 0.03% tacrolimus in the treatment of vitiligo in children under 2 years of age. Meanwhile, serum and urine samples were collected, and liquid chromatography–mass spectrometry was performed to generate the serum and urine metabolic profile data of patients and healthy controls.
Results
The overall response rate at the sixth month, which was defined by the degree of re-pigmentation, was 100%. As revealed by blood monitoring and metabolite detection 6 months later, there was no difference between the treatment group and the control group. There is no evidence that long-term topical application of 0.03% tacrolimus ointment will cause metabolite or other physical changes in the body.
Conclusions
Tacrolimus ointment appears to be effective and safe in the treatment of vitiligo in children younger than 2 year.
Trial registration
http://www.chictr.org.cn identifier: ChiCTR 2100045920.
Impact
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We first reported the efficacy and safety of topical application of 0.03% tacrolimus ointment in infants with vitiligo characterized by the metabolites.
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There is no evidence that long-term topical application of 0.03% tacrolimus ointment will cause metabolite or other physical changes in the body.
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This study provide evidence for the TCI treatment of infants with vitiligo.
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Data availability
The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Funding
This study was supported by the National Natural Science Foundation of China (81803131, 81773335 and 82003322), the Basic Public Welfare Research Project of Zhejiang Province (LGF18H110002), Natural Science Foundation of Zhejiang Province (LY18H110001), and the Health Science and Technology Projects of Hangzhou (A20220451).
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A.-e.X. designed the research, F.L. and J.L. performed the research, and F.L. and W.H. analyzed data and wrote the paper.
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Informed consent was obtained in all cases, and protocols were approved by the scientific ethical committee of Hospital and registered in Chinese Clinical Trial Registry.
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Hu, W., Lin, F., Lei, J. et al. Impacts of exposure to topical calcineurin inhibitors on metabolism in vitiligo infants. Pediatr Res 93, 661–665 (2023). https://doi.org/10.1038/s41390-022-02133-5
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DOI: https://doi.org/10.1038/s41390-022-02133-5
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