Treatment of chronic erosive oral lichen planus with low concentrations of topical tacrolimus: an open prospective study.
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.


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


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


METHODS
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 Two patients were withdrawn because of noncompliance; findings in 8 were available for evaluation.


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


METHODS
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.


CONCLUSIONS
Results of our study suggest a rapid and important palliating effect of low concentration of topical tacrolimus in distilled water in patients with EOLP.
Olivier
Valérie
V
Department of Dermatology, Hôpital Archet-2, BP 3079, 06202 Nice CEDEX, France.
Lacour
Jean-Philippe
JP
Mousnier
Aline
A
Garraffo
Rodolphe
R
Monteil
Roger A
RA
Ortonne
Jean-Paul
JP
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D017676:Lichen Planus, Oral / Q000188:drug therapy* / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000008:administration & dosage*; D016896:Treatment Outcome
D016559:Tacrolimus