Tacrolimus 0.03% ointment treatment in exfoliative cheilitis: A randomised controlled clinical trial and monitoring blood concentration

Abstract Background Tacrolimus has been used to treat various inflammatory skin diseases, but its safety for topical application on the oral mucosa is unknown. Exfoliative cheilitis (EC) is a chronic inflammatory disorder of the lips characterised by repeated scaling; it is difficult to manage. The aim of this study was to assess the efficacy and safety of tacrolimus 0.03% ointment as a topical treatment in patients with EC. Methods In this randomised controlled clinical trial, 40 patients with EC were randomly assigned to receive either tacrolimus 0.03% ointment (experimental group, n = 20) or triamcinolone acetonide 0.1% cream (control group, n = 20) treatment for a 3‐week period. Medication was administered in 3, 2 and 1 daily doses during the first, second and third weeks, respectively. The patients with complete healing were followed up for 3 months. The clinical outcomes were measured, including the scores regarding signs (scale, dryness, rhagades and swelling) and symptoms (rough, dry, pain, pruritus and burning sensation) at every visit. Blood concentrations of tacrolimus were assessed. Results After the 3‐week treatment, healing rates of scale in the experimental and control groups were 65% and 10%, respectively ( P = .018). Improvement in all signs and two symptoms (rough, pruritus) was much greater in the experimental group ( P < .05). The 3‐month recurrence rate was higher in the control group ( P = .029). Tacrolimus blood concentrations were in the safe range (< 5 ng/mL). Conclusion Topical tacrolimus 0.03% ointment has good short‐term efficacy and safety for treating EC.