Efficacy and safety of tacrolimus ointment 0.1% vs. betamethasone 17-valerate 0.1% in the treatment of chronic paronychia: an unblinded randomized study.

BACKGROUND: Recent studies have established the pivotal role of irritants and allergens in development of chronic paronychia and the significant improvement with corticosteroid therapy. OBJECTIVES: The objective of this randomized, unblinded, comparative study was to compare the efficacy of tacrolimus ointment 0.1% vs. betamethasone 17-valerate 0.1% in the treatment of chronic paronychia. METHODS: Forty-five patients with chronic paronychia were randomized 1:1:1 to apply twice daily either betamethasone 17-valerate 0.1% or tacrolimus 0.1% ointment or emollient. Protective measures were counselled to all patients. Treatment duration was 3 weeks and patients were followed for an additional 6 weeks. RESULTS: Eight patients in the betamethasone group were considered as cured, two as improved and four as nonresponders at the end of the treatment period. Thirteen patients in the tacrolimus group were considered as cured and one as improved at the end of the treatment period. Nine patients in the emollient group were considered as stable and six failed to respond. Both betamethasone and tacrolimus groups presented statistically significantly greater cure or improvement rates when compared with the emollient group (P<0.001). CONCLUSIONS: Tacrolimus ointment appears to be a more efficacious agent than betamethasone 17-valerate or placebo for the treatment of chronic paronychia.