Efficacy of topical tacrolimus for oral lichen planus: a retrospective cohort study stratified by cutaneous involvement.

BACKGROUND

Oral lichen planus (OLP) is a chronic T-cell-mediated inflammatory mucocutaneous disorder with limited evidence on topical tacrolimus efficacy in subgroups based on cutaneous involvement.

METHODS

This single-center retrospective cohort study analyzed data (2019-2024) from 120 biopsy-confirmed OLP patients after propensity score matching. Patients were classified according to treatment with topical tacrolimus 0.1% gel or clobetasol propionate 0.05% gel and stratified by cutaneous involvement. Primary outcomes included 8-week changes in visual analog scale (VAS) pain and total atrophic area (TAA), analyzed using mixed-effects models.

RESULTS

Patients with cutaneous involvement exhibited higher baseline severity (p < 0.01). Tacrolimus use was associated with significant reductions in VAS (-1.2; 95% CI -1.7 to -0.7) and TAA (-1.0; 95% CI -1.4 to -0.6) compared to controls. The response rate was superior in the tacrolimus group (OR 3.2; 95% CI 1.5-6.8; p = 0.002). Notably, treatment effects were stronger in patients with cutaneous involvement (interaction p < 0.05). Adverse events were mild and transient; the most common event was burning sensation.

CONCLUSIONS

Topical tacrolimus was associated with improved short-term OLP outcomes and may be particularly useful as a second-line or steroid-sparing option in patients with concomitant cutaneous involvement.