P105 Sustained use of topical tacrolimus for seborrhoeic dermatitis: revisiting cancer risk in light of chronic inflammatory control – a meta-analysis

Abstract

Seborrhoeic dermatitis (SD) is a chronic inflammatory dermatosis with significant psychosocial burden, particularly when facially predominant or steroid refractory. Topical tacrolimus is increasingly used as a steroid-sparing option, yet concerns persist regarding a putative association with cutaneous and systemic malignancy arising from historic black box warnings. We aimed to synthesize the evidence on the long-term efficacy, safety and neoplasia risk associated with topical tacrolimus in SD, with a focus on chronic maintenance therapy and high-risk (steroid-refractory or immuno­compromised) populations. A PRISMA-compliant systematic review and meta-analysis of PubMed, Embase, Web of Science, Scopus, Cochrane CENTRAL and ClinicalTrials.gov (2003–2025) was undertaken. Eligible studies included randomized controlled trials, cohorts, case–control studies and case series (at least five patients) assessing topical tacrolimus (≥ 3 months’ use) in SD or reporting malignancy outcomes in dermatological populations exposed to topical calcineurin inhibitors. Data were pooled using random effects models to estimate effect sizes for clinical efficacy and cancer risk. Twenty-one SD-focused studies and 10 large safety datasets were included. Randomized controlled trials demonstrated that tacrolimus 0.1% is at least noninferior to low-potency corticosteroids and ciclopirox for facial SD, with superior relapse prevention and reduced application frequency in proactive regimens. Pooled analyses showed high rates of clearance or improvement with predominantly mild, transient application-site burning and no excess serious adverse events. Across more than 3.4 million patients exposed to calcineurin inhibitors, meta-analytical estimates showed no statistically significant increase in overall malignancy, lymphoma or nonmelanoma skin cancer. Apparent early signals for cutaneous T-cell lymphoma were attenuated on longer follow-up and were plausibly explained by protopathic bias. Topical tacrolimus is an effective, well-tolerated and genuinely steroid-sparing long-term therapy for SD, including on cosmetically sensitive facial sites. Contemporary high-quality evidence does not support an increased malignancy risk with sustained topical use, challenging current prescribing hesitancy and supporting guideline-level endorsement as a frontline or maintenance option in chronic SD.