European Journal of Dermatology


Pimecrolimus 1% cream for mild-to-moderate atopic dermatitis: a systematic review and meta-analysis with a focus on children and sensitive skin areas Volume 33, issue 5, September-October 2023


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1 Department of Dermatology, University of Münster, Münster, Germany
2 Department of Dermatology, National Taiwan University College of Medicine and National Taiwan University Hospital, Taipei, Taiwan
3 Saudi Airline Medical Services Center, Riyadh, Saudi Arabia
4 Institut Pediatrik, Hospital Tunku Azizah, Kuala Lumpur, Malaysia
5 National Medical Research Center for Children’s Health, Moscow, Russian Federation
6 Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation
7 Central State Medical Academy of the Presidential Administration of the Russian Federation, Moscow, Russian Federation
8 Research Institute for Pediatrics and Children’s Health Protection, Federal National Public Healthcare Institution “Central Clinical Hospital of the Russian Academy of Sciences”, Ministry of Science and Higher Education, Moscow, Russian Federation
9 SmartAnalyst India Pvt. Ltd., an Ashfield Advisory Company, DLF Plaza, DLF Phase 1, Gurugram, Haryana, India
10 Department of Dermatology and Venereology National Clinical Research Center for Skin and Immune Diseases, Peking University First Hospital, Beijing, China
* Reprints: Thomas Luger,

This systematic literature review (SLR) and meta-analysis assessed the efficacy and safety of pimecrolimus vs other topical treatments in patients with mild-to-moderate atopic dermatitis (AD), focusing on children and sensitive skin areas. An SLR was conducted in MEDLINE, Embase and Cochrane Library databases on January 15th, 2020, to identify randomized controlled trials (RCTs) with pimecrolimus as a study arm. Another SLR performed on October 5th, 2020 identified RCTs with a crisaborole study arm. Direct pair-wise meta-analysis was used to compare pimecrolimus with vehicle, tacrolimus or topical corticosteroids (TCS; n = 27 studies). Outcomes included Investigator’s Global Assessment (IGA) score 0/1 up to week 6 and adverse events. Pimecrolimus was more efficacious than vehicle in achieving IGA 0/1 up to week 6 in children, and similar safety profiles were observed with pimecrolimus and vehicle in children and the mixed population, including on sensitive skin. No significant differences in efficacy and safety were observed between pimecrolimus and tacrolimus 0.03%. Efficacy and safety were similar for pimecrolimus and mild medium potency TCS; mildly potent steroids caused transient epidermal thinning in sensitive skin areas (not seen with pimecrolimus). Pimecrolimus can be considered as a first-line option for mild-to-moderate AD, particularly in children and sensitive skin areas.

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