Skip to main content
Log in

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

  • Short Communication
  • Published:
Clinical Drug Investigation Aims and scope Submit manuscript



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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Subscribe and save

Springer+ Basic
EUR 32.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or Ebook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2
Fig. 3
Fig. 4


  1. Zhang XJ, Liu JB, Gui JP, Li M, Xiong QG, Wu HB, et al. Characteristics of genetic epidemiology and genetic models for vitiligo. J Am Acad Dermatol. 2004;51:383–90.

    Article  Google Scholar 

  2. Sidbury R, Davis DM, Cohen DE, Cordoro KM, Berger TG, Bergman JN, et al. Guidelines of care for the management of atopic dermatitis: section 3. Management and treatment with phototherapy and systemic agents. J Am Acad Dermatol. 2014;71:327–49.

    Article  Google Scholar 

  3. Boone B, Ongenae K, Van Geel N, Vernijns S, De Keyser S, Naeyaert JM. Topical pimecrolimus in the treatment of vitiligo. Eur J Dermatol. 2007;17:55–61.

    CAS  PubMed  Google Scholar 

  4. Manthripragada AD, Pinheiro SP, MaCurdy TE, Saneinejad S, Worrall CM, Kelman JA, et al. Off-label topical calcineurin inhibitor use in children. Pediatrics. 2013;132:e1327–32.

    Article  Google Scholar 

  5. Nicolaidou E, Mastraftsi S, Tzanetakou V, Rigopoulos D. Childhood vitiligo. Am J Clin Dermatol. 2019;20(4):515–26.

    Article  Google Scholar 

  6. Sigurgeirsson B, Boznanski A, Todd G, Vertruyen A, Schuttelaar ML, Zhu X, et al. Safety and efficacy of pimecrolimus in atopic dermatitis: a 5-year randomized trial. Pediatrics. 2015;135:597–606.

    Article  Google Scholar 

  7. Lee SJ, Woo SI, Ahn SH, Lim DK, Hong JY, Park JH, et al. Functional interpretation of metabolomics data as a new method for predicting long-term side effects: treatment of atopic dermatitis in infants. Sci Rep. 2014;4:7408.

    Article  CAS  Google Scholar 

  8. Mandelin JM, Rubins A, Remitz A, Cirule K, Dickinson J, Ho V, et al. Long-term efficacy and tolerability of tacrolimus 0.03% ointment in infants: a two-year open-label study. Int J Dermatol. 2012;51:104–10.

    Article  CAS  Google Scholar 

  9. Bae JM, Yoo HJ, Kim H, Lee JH, Kim GM. Combination therapy with 308-nm excimer laser, topical tacrolimus, and short-term systemic corticosteroids for segmental vitiligo: a retrospective study of 159 patients. J Am Acad Dermatol. 2015;73:76–82.

    Article  CAS  Google Scholar 

  10. Udompataikul M, Boonsupthip P, Siriwattanagate R. Effectiveness of 0.1% topical tacrolimus in adult and children patients with vitiligo. J Dermatol. 2011;38:536–40.

    Article  CAS  Google Scholar 

  11. Kanwar AJ, Dogra S, Parsad D. Topical tacrolimus for treatment of childhood vitiligo in Asians. Clin Exp Dermatol. 2004;29:589–92.

    Article  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations


Corresponding author

Correspondence to Ai-E Xu.

Ethics declarations


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.

Ethical approval

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

Informed consent was obtained from parents of all individual participants included in this study.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary material 1 (PDF 1056 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Hu, W., Xu, Y., Ma, Y. et al. 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. Clin Drug Investig 39, 1233–1238 (2019).

Download citation

  • Published:

  • Issue Date:

  • DOI: