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An Open Prospective Study

Valérie Olivier, MD; Jean-Philippe Lacour, MD; Aline Mousnier, PharmD; Rodolphe Garraffo, PharmD, PhD; Roger A. Monteil, DDS; Jean-Paul Ortonne, MD

Arch Dermatol. 2002;138:1335-1338.

Background  Chronic erosive oral lichen planus (EOLP) is a severe form of lichen of the buccal mucosa that is often resistant to systemic or topical therapies.

Objective  To evaluate the efficacy and safety of topical tacrolimus, 0.1 mg per 100 mL of water, in treating EOLP.

Design  Open-label, prospective, noncomparative study, with 6 months of treatment and 6 months of follow-up.

Setting  Dermatology department at a university hospital in Nice, France.

Patients  Ten patients with histologically proved EOLP that was refractory to treatment. Two patients were withdrawn because of noncompliance; findings in 8 were available for evaluation.

Interventions  Mouthwashes with tacrolimus, 0.1 mg per 100 mL of distilled water, 4 times daily for 6 months.

Main Outcome Measures  Efficacy was assessed using a calculated score that combined the intensity of spontaneous and meal-triggered pain and the surface area of erosions. Safety assessment included the monitoring of adverse effects, clinical laboratory values, and blood concentrations of tacrolimus.

Results  Among the 8 patients evaluated, 1 had no improvement and 7 were improved. The mean score decreased from 7.00 at baseline to 5.43 (a 22.43% decrease) at 1 month, 4.14 (a 40.86% decrease) at 2 months, 3.00 (a 57.14% decrease) at 3 months, 2.43 (a 65.29% decrease) at 4 months, 2.57 (a 63.29% decrease) at 5 months, and 3.43 (a 51.00% decrease) at 6 months. A decrease of symptoms was reported by the 7 responding patients as soon as the first month of treatment. No severe adverse effects were observed. All patients had whole-blood concentrations of tacrolimus below the detection limit of the assay (1.5 ng/mL) at all intervals. At 9 months, 6 patients had had a relapse within a mean of 38.6 days. At 12 months, all patients had had a relapse and required treatment with topical corticosteroids or systemic hydroxychloroquine sulfate.

Conclusion  Results of our study suggest a rapid and important palliating effect of low concentration of topical tacrolimus in distilled water in patients with EOLP.

From the Departments of Dermatology (Drs Olivier, Lacour, and Ortonne) and Pharmacy (Dr Mousnier), Hôpital Archet, and the Laboratories of Pharmacology (Dr Garraffo) and Oral Pathobiology (Dr Monteil), Hôpital Pasteur, Nice, France.

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