A double-blind, randomized controlled trial of clobetasol versus pimecrolimus in patients with vulvar lichen sclerosus.

Author(s): Goldstein AT, Creasey A, Pfau R, Phillips D, Burrows LJ.

Affiliation(s): 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

Publication date & source: 2011, J Am Acad Dermatol. , 64(6):e99-104

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. LIMITATIONS: This study was limited by the relatively short study duration. CONCLUSION: 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.