THERAPEUTICS DOI 10.1111/j.1365-2133.2005.06920.x Ciclosporin vs. clobetasol in the topical management of atrophic and erosive oral lichen planus: a double-blind, randomized controlled trial D. Conrotto, M. Carbone, M. Carrozzo, P. Arduino, R. Broccoletti, M. Pentenero and S. Gandolfo Department of Biological Sciences and Human Oncology, Oral Medicine Section, University of Turin, C.so Dogliotti 38, 10126 Turin, Italy Correspondence Marco Carrozzo. E-mail: marco.carrozzo@unito.it Accepted for publication 2 June 2005 Key words: ciclosporin, clobetasol, erosive, lichen planus, oral, randomized controlled trial Conflicts of interest: None declared. Summary Background Oral lichen planus (OLP) is a chronic inflammatory disease that can be painful, especially in the atrophic and erosive forms. Several drugs have been used with varying results, but most treatments are empirical, and do not have adequate control groups or correct study designs. Objectives To compare the effectiveness of clobetasol and ciclosporin in the topical management of OLP and to evaluate which is more cost-effective and which gives the longest remission from signs and symptoms. Methods A randomized, comparative, double-blind study was designed. Forty con- secutive patients were divided into two groups to receive clobetasol propionate or ciclosporin for 2 months. Both drugs were placed in 4% hydroxyethyl cellu- lose bioadhesive gel. Antimycotic prophylaxis was also given. After the end of therapy, patients underwent a 2-month follow-up. Results Eighteen of 19 clobetasol-treated patients (95%) improved after 2 months of therapy, while 13 of 20 ciclosporin-treated patients (65%) had a clinical response (P ¼ 0Æ04). Symptomatology improved in 18 clobetasol-treated patients (95%) and in 17 ciclosporin-treated patients (85%) (not statistically significantly different). Two months after the end of therapy, 33% of clobetasol-treated patients and 77% of ciclosporin-treated patients were stable (P ¼ 0Æ04). Clobeta- sol produced significantly more side-effects than ciclosporin (P ¼ 0Æ04). The daily cost of ciclosporin treatment was 1Æ82 € compared with 0Æ35 € for clobeta- sol therapy. Conclusions Clobetasol is more effective than ciclosporin in inducing clinical improvement, but the two drugs have comparable effects on symptoms. Con- versely, clobetasol gives less stable results than ciclosporin when therapy ends and has shown a higher incidence of side-effects. The daily cost of ciclosporin is more than five times higher than clobetasol. Oral lichen planus (OLP) is a chronic inflammatory disease that can be painful, especially in the atrophic and erosive forms. As the aetiology remains unknown in many cases, most therapies are only symptomatic. OLP probably represents a cell-mediated immunological response to an induced antigenic change in the skin or mucosa in predisposed subjects. 1 Thus, the use of immunomodulators or immunosuppressants to con- trol the disease would appear reasonable. Several drugs have been used with varying results, but most treatments are empirical, without adequate control groups or correct study designs. 2 Some of the main problems involved in the management of OLP and in the choice of treatment include the chronic nature of this disease, requiring long-term therapy, the patient’s medical history (liver disease, diabetes, hypertension, psycho- logical state), and compliance with and cost-effectiveness of treatment. Several recent reviews on OLP therapy are available: 2–9 most suggest that the best treatment remains high-potency topical corticosteroids. Among these studies, clo- betasol propionate appeared to be the most effective topical steroid, as treatment in an adhesive base led to complete remission in 56–75% of patients. 7,10–14 Topically applied ciclosporin is also frequently used in the treatment of OLP, although not all patients have shown significant benefits. 15–26 Indeed, in a study 27 of 13 patients with OLP randomly assigned to treatment with either ciclosporin (500 mg as a swish-and-spit medication for 5 min, three times daily) or a triamcinolone acetonide oral paste over 6 weeks, only slight, Ó 2005 British Association of Dermatologists • British Journal of Dermatology 2006 154, pp139–145 139