Tacrolimus powder in Orabase 0.1% for the treatment of oral lichen planus and oral lichenoid lesions: an open clinical trial.

Objectives: The aim of our study was to evaluate the clinical efficacy and safety profile of a novel compound, Tacrolimus powder in Orabase 0.1% in patients with LP and LL.

Study Design: Seven patients with LP and 3 with LL were asked to participate. All patients received a 1 week treatment of Fluconazole, prior to entering the study, and on follow up visit were provided with a 15 g container of the study medication. Patients were asked to treat the most symptomatic site, three times a day for two weeks.

Results: Disease control (signs) was achieved in most patients by the end of two weeks (from 1.58 to 0.55); all patients experienced a high degree of discomfort (pain) at baseline, which dropped quickly by the end of the second week of treatment (from 1.95 to 0.45); none developed yeast during the course of treatment. Recurrent headaches were reported by one patient with erosive LP, and transient burning by a patient with reticular LP.

Conclusions: Tacrolimus powder in Orabase 0.1% appears to have a relatively safe profile, and represents a likely alternative to topical steroids in the treatment of LP and LL, especially in those at risk for oral candidiasis.