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

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.
Journal of the American Academy of Dermatology (Impact Factor: 4.45). 02/2011; 64(6):e99-104. DOI: 10.1016/j.jaad.2010.06.011
Source: PubMed


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.
We sought to compare the safety and efficacy of clobetasol and pimecrolimus in the treatment of vulvar LS.
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.
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.
This study was limited by the relatively short study duration.
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.

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    • "Interest has been shown in the topical calcineurin inhibitors tacrolimus and pimecrolimus (Hengge 2006; Goldstein 2011). One RCT found no differences between pimecrolimus and clobetasol propionate in relieving the symptoms of pruritus and burning/pain. "
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    ABSTRACT: Lichen sclerosus (LS) is an inflammatory skin disease that usually involves the anogenital area. All patients with symptoms or signs suspicious of lichen sclerosus should be seen at least once initially by a physician with a special interest in the disease in order to avoid delay in diagnosis, as early treatment may cure the disease in some and reduce or prevent scarring. The diagnosis is made clinically in most cases. Biopsies should only be performed under certain circumstances. The gold standard for treatment remains potent to very potent topical steroids; however, mild and moderate disease in boys and men may be cured by circumcision. Certain triggers should be avoided. © 2015 European Academy of Dermatology and Venereology.
    Journal of the European Academy of Dermatology and Venereology 07/2015; DOI:10.1111/jdv.13136 · 2.83 Impact Factor
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    • "The place of topical calcineurin inhibitors in the treatment of lichen sclerosus and other conditions such as lichen planus is worth thinking about. Topical calcineurin inhibitors are to be considered as a second-line treatment, when all reasonably possible adjustments of corticoid creams have been tested [8]. In some instances, corticoid creams are not or no more tolerated (delayed-type hypersensitivity reactions) or become less efficient, leading to increasing treatment doses (tachyphylaxis ). "
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    ABSTRACT: The objective of this paper is to present general considerations which should be kept in mind by clinicians in charge of women with vulvar diseases. Four representative vulvar dermatoses are described. Lichen simplex chronicus is a pathological condition related to chemical and mechanical irritant agents. Detrimental effects of these irritants, in the presence of other dermatoses, have to be considered when therapeutic responses are unsatisfactory. Lichen sclerosus is the most common vulvar dermatosis in elderly. However, it should be kept in mind that it may be diagnosed at any age. Lichen planus, in spite of sharing a similar range of etiological factors with lichen sclerosus, is a very distinct entity. Finally, Paget's disease, although rare, is also described especially because of the challenge it represents both clinically and therapeutically.
    01/2014; 2014:595286. DOI:10.1155/2014/595286
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    • "The first and only comparative study is a double-blind, randomized controlled trial comparing the safety and efficacy of clobetasol with pimecrolimus in the treatment of vulvar LS [107]. Seventeen women in the pimecrolimus group and 19 women in the clobetasol group all had biopsy-proven vulvar LS. "
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    ABSTRACT: Lichen sclerosus (LS) is a chronic, inflammatory, mucocutaneous disorder of genital and extragenital skin. LS is a debilitating disease, causing itch, pain, dysuria and restriction of micturition, dyspareunia, and significant sexual dysfunction in women and men. Many findings obtained in recent years point more and more towards an autoimmune-induced disease in genetically predisposed patients and further away from an important impact of hormonal factors. Preceding infections may play a provocative part. The role for Borrelia is still controversial. Trauma and an occlusive moist environment may act as precipitating factors. Potent and ultrapotent topical corticosteroids still head the therapeutic armamentarium. Topical calcineurin inhibitors are discussed as alternatives in the treatment of LS in patients who have failed therapy with ultrapotent corticosteroids, or who have a contraindication for the use of corticosteroids. Topical and systemic retinoids may be useful in selected cases. Phototherapy for extragenital LS and photodynamic therapy for genital LS may be therapeutic options in rare cases refractory to the already mentioned treatment. Surgery is restricted to scarring processes leading to functional impairment. In men, circumcision is effective in the majority of cases, but recurrences are well described. Anogenital LS is associated with an increased risk for squamous cell carcinoma of the vulva or penis. This review updates the epidemiology, clinical presentation, histopathology, pathogenesis, and management of LS of the female and male genitals and extragenital LS in adults and children.
    American Journal of Clinical Dermatology 02/2013; 14(1):27-47. DOI:10.1007/s40257-012-0006-4 · 2.73 Impact Factor
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