Clinical evidence on topical tacrolimus in exfoliative cheilitis: a systematic review

Mariane Cordeiro dos Santos; Matheus Kawana Couto; Gabriela Cristina Santin; Elen de Souza Tolentino

doi:10.5327/2525-5711.406

Authors

Mariane Cordeiro dos Santos State University of Maringa, Department of Dentistry – Maringa (PR), Brazil. https://orcid.org/0009-0007-5479-3949
Matheus Kawana Couto State University of Maringa, Department of Dentistry – Maringa (PR), Brazil. https://orcid.org/0000-0003-1990-9487
Gabriela Cristina Santin State University of Maringa, Department of Dentistry – Maringa (PR), Brazil. https://orcid.org/0000-0003-0216-0502
Elen de Souza Tolentino State University of Maringa, Department of Dentistry – Maringa (PR), Brazil. https://orcid.org/0000-0002-4352-4694

DOI:

https://doi.org/10.5327/2525-5711.406

Keywords:

Exfoliaive cheilitis, Lip diseases, Treatment Outcome, Tacrolimus

Abstract

This systematic review aimed to evaluate the available clinical evidence regarding the efficacy and safety of topical tacrolimus in the treatment of exfoliative cheilitis (EC). A systematic review was conducted in accordance with PRISMA guidelines and registered in PROSPERO (CRD420251043565). Searches were performed through PubMed, Scopus, Web of Science, SciELO, Embase, Cochrane Library, Google Scholar and grey literature. Manual searches for reference lists were conducted. Two independent reviewers selected studies, extracted data and assessed bias. Eligible studies included randomized controlled trials (RCTs), cohort, case-control studies, and case series. Risk of bias was evaluated using RoB 2.0 and JBI checklists. Two studies met inclusion criteria: one RCT and one cross-sectional study, totaling 61 participants. Both evaluated topical tacrolimus for EC, with concentrations of 0.03 and 0.1%. Most patients achieved complete clinical resolution compared to control groups (triamcinolone acetonide and petroleum jelly) during 3–6 months follow-up, demonstrating significantly lower recurrence rates (30.8-38.5% vs. 61.5-100% in controls; p<0.05 for both comparisons). The pooled data demonstrated negligible treatment-related adverse effects. While demonstrating safety and efficacy, tacrolimus therapy is associated with recurrence rates surpassing 30% during 3–6-month follow-up. EC is highly prevalent but remains a clinical challenge due to its unclear etiopathogenesis, which hinders the development of evidence-based treatments. Considering its substantial symptomatic and aesthetic impact, our findings highlight the urgent need for high-quality research in this area.

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