title: Pimecrolimus cream 1% in erosive oral lichen planus--a prospective randomized double-blind vehicle-controlled study.
abstract: BACKGROUND
  Erosive oral lichen planus (EOLP) is a T-cell mediated inflammatory disease leading to severe pain and impairment. As current therapies are of limited efficacy, application of calcineurin inhibitors is considered to be a potential option.
  
  
  OBJECTIVE
  To investigate the efficacy of pimecrolimus cream 1% (Elidel) compared with vehicle cream in the treatment of EOLP.
  
  
  METHODS
  Twenty patients were enrolled in a prospective, double-blind, randomized, vehicle-controlled trial and assigned to either pimecrolimus or vehicle group. Study medication was applied for 30 days followed by 30 days of observation without therapy. In case of unresponsiveness, treatment was continued for 30 days with open-label pimecrolimus. EOLP was monitored on days 0, 30 and 60. Safety was assessed by patient documentation, measurement of pimecrolimus levels and blood counts.
  
  
  RESULTS
  Within 30 days erosions cleared completely in seven of 10 patients treated with pimecrolimus and in two of 10 patients treated with vehicle. The clinical EOLP 'composite score' including mucosal erosions and pain sensation was significantly reduced in the pimecrolimus-treated group compared with vehicle (P = 0.025). In the three of 10 patients not responding to pimecrolimus, EOLP cleared after an additional 30 days of treatment with pimecrolimus. Following termination of the therapy, sustained remission of EOLP was detected in 83% of patients demonstrating long-lasting effects of pimecrolimus treatment. No severe adverse events were observed. In five patients pimecrolimus blood levels were detected, all of which stayed below 4 ng mL(-1).
  
  
  CONCLUSIONS
  Pimecrolimus cream 1% effectively treats EOLP with long-lasting therapeutic effects and is therefore a promising therapeutic option for EOLP.
authors.affiliation: Department of Dermatology, Eberhard Karls University, Liebermeisterstrasse 25, 72076 Tübingen, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Volz
authors.forename: U
authors.initials: U
authors.lastname: Caroli
authors.forename: H
authors.initials: H
authors.lastname: Lüdtke
authors.forename: M
authors.initials: M
authors.lastname: Bräutigam
authors.forename: H
authors.initials: H
authors.lastname: Kohler-Späth
authors.forename: M
authors.initials: M
authors.lastname: Röcken
authors.forename: T
authors.initials: T
authors.lastname: Biedermann
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D003879:Dermatologic Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017676:Lichen Planus, Oral / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009824:Ointments; D011446:Prospective Studies; D016559:Tacrolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D003879:Dermatologic Agents; D009824:Ointments; C117268:pimecrolimus; D016559:Tacrolimus