title: Treatment of chronic erosive oral lichen planus with low concentrations of topical tacrolimus: an open prospective study.
abstract: 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 Two patients were withdrawn because of noncompliance; findings in 8 were available for evaluation.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.
authors.affiliation: Department of Dermatology, Hôpital Archet-2, BP 3079, 06202 Nice CEDEX, France.
authors.forename: Valérie
authors.initials: V
authors.lastname: Olivier
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Lacour
authors.forename: Aline
authors.initials: A
authors.lastname: Mousnier
authors.forename: Rodolphe
authors.initials: R
authors.lastname: Garraffo
authors.forename: Roger A
authors.initials: RA
authors.lastname: Monteil
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Ortonne
mesh_terms: 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
chemical_list: D016559:Tacrolimus