title: Pimecrolimus 1% cream for oral erosive lichen planus: a 6-week randomized, double-blind, vehicle-controlled study with a 6-week open-label extension to assess efficacy and safety.
abstract: OBJECTIVE
  To assess the efficacy and safety of topical pimecrolimus 1% cream in the treatment of oral erosive lichen planus.
  
  
  METHODS
  A 6-week randomized, double-blind, vehicle-controlled phase followed by a 6-week open-label phase.
  
  
  METHODS
  Outpatients of the Department of Dermatology, University of Utah.
  
  
  METHODS
  Twenty-one patients with oral erosive lichen planus were randomized and treated with either pimecrolimus 1% cream or vehicle cream.
  
  
  METHODS
  Pimecrolimus 1% cream, or its vehicle, were applied twice daily for 6 weeks to each side of the mouth with a 2×2 inch gauze pad folded in half and placed directly on the erosive lesion.
  
  
  METHODS
  Efficacy was based on clinical evaluation of Investigator's Global Assessment (IGA) of the overall severity of the disease, erythema, measurement of the size of any target erosion in millimetres, and assessment of spontaneous pain. Blood levels of pimecrolimus were monitored in all subjects on day 0 and repeated on day 7.
  
  
  RESULTS
  Pimecrolimus 1% cream was superior to vehicle cream in reducing mean IGA, pain, and erosion size. For the vehicle group that entered the open-label phase, pimecrolimus 1% cream improved the mean IGA, pain, erosion size, and erythema. Pimecrolimus levels were detected in nine out of 10 of the pimecrolimus-treated subjects. These levels were consistently low. The pimecrolimus cream was well-tolerated. No clinically relevant, drug-related adverse events were reported.
  
  
  CONCLUSIONS
  Pimecrolimus 1% cream was superior to vehicle in reducing pain, erythema, decreasing erosion size, and improving overall severity of disease when compared with vehicle treatment.
authors.affiliation: Department of Dermatology, University of Utah, Salt Lake City, UT, USA.
authors.forename: C
authors.initials: C
authors.lastname: McCaughey
authors.forename: M
authors.initials: M
authors.lastname: Machan
authors.forename: R
authors.initials: R
authors.lastname: Bennett
authors.forename: J J
authors.initials: JJ
authors.lastname: Zone
authors.forename: C M
authors.initials: CM
authors.lastname: Hull
mesh_terms: D000287:Administration, Topical; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D017676:Lichen Planus, Oral / Q000188:drug therapy*; D016559:Tacrolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D003879:Dermatologic Agents; C117268:pimecrolimus; D016559:Tacrolimus