title: A double-blind, randomized controlled trial of clobetasol versus pimecrolimus in patients with vulvar lichen sclerosus.
abstract: BACKGROUND
  Lichen sclerosus (LS) is a lymphocyte-mediated chronic cutaneous disorder with a predilection for the vulva. The current gold standard treatment is topical ultrapotent corticosteroids such as clobetasol.
  
  
  OBJECTIVE
  We sought to compare the safety and efficacy of clobetasol and pimecrolimus in the treatment of vulvar LS.
  
  
  METHODS
  This double-blind, randomized trial enrolled 38 women with biopsy-proven vulvar LS. This study consisted of a 2-week screening period and a 12-week treatment period. The primary efficacy variable was the change in inflammation, as determined by a dermatopathologist, on the biopsy specimens obtained at screening and at the week 12 visit. Secondary efficacy variables included the change from baseline in pruritus and burning/pain as assessed by patients using a visual analog scale and a clinical evaluation by the investigator.
  
  
  RESULTS
  Clobetasol was found to be superior in improving inflammation when compared with pimecrolimus (P = .015). Both groups showed improvement in pruritus and burning/pain but this difference was not statistically significant (P = .32 and .93, respectively). Both clobetasol and pimecrolimus were found to be effective in decreasing both the total score on the Investigator Global Assessment (P = .001) and all 3 subscales. Serum levels of pimecrolimus and clobetasol did not approach levels of concern during the study period. No adverse events were reported.
  
  
  CONCLUSIONS
  This study was limited by the relatively short study duration.
  
  
  CONCLUSIONS
  Both clobetasol and pimecrolimus appear efficacious and well tolerated for the treatment of vulvar LS; however, clobetasol is more effective than pimecrolimus and should remain first-line therapy for LS.
authors.affiliation: George Washington University School of Medicine and Health Sciences, Obstetrics and Gynecology, Center for Vulvovaginal Disorders, 3 Washington Circle NW, Suite 215, Washington, DC 20037, USA. obstetrics@yahoo.com
authors.forename: Andrew T
authors.initials: AT
authors.lastname: Goldstein
authors.forename: Alia
authors.initials: A
authors.lastname: Creasey
authors.forename: Richard
authors.initials: R
authors.lastname: Pfau
authors.forename: Daniel
authors.initials: D
authors.lastname: Phillips
authors.forename: Lara J
authors.initials: LJ
authors.lastname: Burrows
mesh_terms: D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002990:Clobetasol / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D010147:Pain Measurement; D016559:Tacrolimus / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D007724:Vulvar Lichen Sclerosus / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; C117268:pimecrolimus; D002990:Clobetasol; D016559:Tacrolimus