A double-blind, randomized controlled trial of clobetasol versus pimecrolimus in patients with vulvar lichen sclerosus - 10/08/11
, Alia Creasey, MPH b, Richard Pfau, MD c, Daniel Phillips, MD d, Lara J. Burrows, MD, MSc e
Reprint requests: Andrew T. Goldstein, MD, George Washington University School of Medicine and Health Sciences, Obstetrics and Gynecology, the Center for Vulvovaginal Disorders, 3 Washington Circle NW, Suite 215, Washington, DC 20037.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.
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.
Le texte complet de cet article est disponible en PDF.Key words : calcineurin inhibitor, corticosteroid, lichen sclerosus, pimecrolimus, vulva
Abbreviations used : IGA, LS, VAS-BP, VAS-PR
Plan
| Research funding for this study was supplied by Novartis Pharmaceuticals Corp, East Hanover, NJ. |
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| Disclosure: Dr Goldstein has received research funding from Novartis Pharmaceuticals and Neocutis, Inc; he is a consultant for Boehinger Ingelheim. All other authors declared no conflict of interest. |
Vol 64 - N° 6
P. e99-e104 - juin 2011 Retour au numéro
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