© 2006 Acta Dermato-Venereologica. ISSN 0001-5555 DOI: 10.2340/00015555-0070 Acta Derm Venereol 86 CLINICAL REPORT Acta Derm Venereol 2006; 86: 227–229 Treatment of symptomatic oral lichen planus remains a challenging problem. This study compared the eficacy of topical tacrolimus ointment with triamcinolone aceto- nide ointment in patients with oral lichen planus. Twenty patients (group I) were treated with topical tacrolimus 0.1% ointment 4 times daily, and 20 (group II) were treated with triamcinolone acetonide 0.1% ointment 4 times daily. The clinical effect was graded after 6 weeks. In group I, 6 patients healed, 12 showed improvement and 2 showed no improvement. In group II, 2 patients healed, 7 improved and 11 showed no improvement. The most commonly reported side-effect in both groups was temporary burning or stinging at the site of application. Unfortunately, oral lesions recurred within 3–9 weeks of cessation of treatment in 13 of the 18 patients who had initially shown an improvement or were healed in group I and in 7 of the 9 patients in group II. Topical tacroli- mus 0.1% ointment induced a better initial therapeutic response than triamcinolone acetonide 0.1% ointment. However, relapses occurred frequently within 3–9 weeks of the cessation of treatment. Key words: side-effects; tre- atment. (Accepted January 19, 2006.) Acta Derm Venereol 2006; 86: 227–229. R. Laeijendecker, Department of Dermatology (loca- tion Dordwijk), Albert Schweitzer Hospital, PO Box 444, NL-3300 AK Dordrecht, The Netherlands. E-mail: R.Laeijendecker@asz.nl Oral lichen planus (OLP) is a common benign inlam- matory disease affecting mainly middle-aged and elderly people, with a prevalence of approximately 0.5–2%. The disease has a female:male ratio of approximately 2:1 and may persist for many years (1). The diagnosis of OLP is based on a combination of characteristic clinical indings, history and histopathological examination. The hyperke- ratotic (white) variant of OLP is often symptomless. The atrophic or the erythematous (red) variant and the erosive or the ulcerative (yellow) variants of OLP generally have persistent symptoms (1–5). Treatment of symptomatic OLP is challenging. Se- veral drugs have been used with varying eficacy (1, 3). Speciic treatment includes corticosteroids (topical, intralesional or systemic), retinoids, cyclosporine, psoralen plus ultraviolet A light (PUVA), griseofulvin, hydroxychloroquine and dapsone (1, 3). Recently, topical tacrolimus was reported to be effec- tive in the treatment of patients with OLP in a number of pilot studies (2–6). However, these studies lacked adequate control groups, and relapses of symptomatic OLP were also reported to occur frequently, generally within weeks of the cessation of topical tacrolimus treatment (2–6).The aim of this prospective randomized study was to compare the eficacy of topical tacrolimus 0.1% ointment with that of triamcinolone acetonide 0.1% ointment in patients with symptomatic OLP. The side-effects of the treatment in each group and the pe- riods of remission after the cessation of therapy were also compared. MATERIALS AND METHODS A prospective randomized study was conducted between 2001 and 2004 in 40 Caucasian patients (30 women, 10 men; age range 32–82 years; mean 58 years) with a confirmed diagnosis of symptomatic OLP based on clinical and histopathologi- cal features at the department of Dermatology of the Albert Schweitzer Hospital, Dordrecht, The Netherlands. Exclusion criteria were: age younger than 18 years; histopathological examination with atypical or lichenoid dysplastic features; asymptomatic oral lesions and specific treatment within 4 weeks prior to the study. The extent and the severity of OLP and the prior treatment schedules in the 40 recruited patients were comparable and showed no statistically significant difference (p > 0.99). All patients were treated for 6 weeks. Treatment was discontinued earlier when patients showed a complete healing. The follow-up period was for at least 3 months. Treatments were randomly allocated to patients in order of inclusion ac- cording to a predetermined randomization-list stratified by sex. The patients were divided into two groups. Each patient was provided with detailed verbal and written information on the study protocol. Each patient provided written informed consent to participate in the study. Ethical approval was obtained prior to commencing the study. In group I, 20 patients were treated with topical tacrolimus 0.1% ointment (Protopic ® 0.1%, Astellas Pharma Inc., The Netherlands), which was applied 4 times a day onto the symp- tomatic oral lesions. In group II, 20 patients were treated with triamcinolone acetonide 0.1% in hypromellose 20% ointment, which was also applied 4 times a day. The reasons for this admi- nistration schedule in both groups were to achieve a comparable level of patient compliance and to achieve effective numbers of application of the ointments because topical agents do not easily adhere to the moist mucous membranes. A Comparison of Treatment of Oral Lichen Planus with Topical Tacrolimus and Triamcinolone Acetonide Ointment Ronald LAEIJENDECKER 1 , Bhupendra TANK 2 , Sybren K. DEKKER 1 and H. A. Martino NEUMANN 2 1 Department of Dermatology, Albert Schweitzer Hospital, Dordrecht and 2 Department of Dermatology and Venereology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands