The Efficacy of Topical Tacrolimus Ointment on Cheilitis Induced by Isotretinoin Treatment in Acne Vulgaris Patients

Abstract

Background: Isotretinoin is a gold standard treatment for moderate to severe acne vulgaris but is associated with cheilitis. Though moisturizing agents or petrolatum have been suggested, uncomfortable isotretinoin-induced cheilitis can disrupt treatment of acne patients. Topical tacrolimus has been used in atopic dermatitis with good safety and efficacy; however, there is no study of application of topical tacrolimus in cheilitis induced by isotretinoin. Objective: In this study, we aimed to describe the efficacy of topical tacrolimus 0.1% ointment on cheilitis associated with isotretinoin therapy using isotretinoin cheilitis grading scale (ICGS), investigator global assessment (IGA), and patient global assessment (PGA). We also observed the side effects of topical tacrolimus ointment. Methods: Fifty acne vulgaris patients with isotretinoin-induced cheilitis were randomly allocated to either topical tacrolimus or petrolatum treatment using permuted-block randomization. Patients were followed-up at 4 and 8 weeks, at which cheilitis lesions were photographed and evaluated with ICGS, IGA, and PGA. Results: Compared to petrolatum group, tacrolimus group had greater responses to treatment as measured by mean values of ICGS, IGA, PGA at follow-up visits. Also, the ICGS decrease was larger in the tacrolimus group compared with the petrolatum group even according to isotretinoin dose. Conclusion: Topical tacrolimus ointment had superior efficacy in treating cheilitis induced by isotretinoin compared to petrolatum. Erythema, fissures, scales, and commissures all showed better response to tacrolimus ointment. Topical tacrolimus ointment can be administered as an effective strategy in treatment of cheilitis as a complication of isotretinoin therapy and can improve compliance of acne patients.