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Journal of the American Academy of Dermatology
Volume 71, n° 1
pages 84-91 (juillet 2014)
Doi : 10.1016/j.jaad.2014.02.019
accepted : 13 February 2014
Original Articles

A double-blind, randomized prospective study evaluating topical clobetasol propionate 0.05% versus topical tacrolimus 0.1% in patients with vulvar lichen sclerosus

Deana Funaro, MD a, b, d, , Audrey Lovett, MD d, Nathalie Leroux, MD c, Julie Powell, MD a
a Department of Dermatology, Ste-Justine Hospital, University of Montreal, Montreal, Quebec, Canada 
b Vulvar Disease Division, Ste-Justine Hospital, University of Montreal, Montreal, Quebec, Canada 
c Department of Gynecology, Ste-Justine Hospital, University of Montreal, Montreal, Quebec, Canada 
d Department of Dermatology, Centre Hospitalier de l'Université de Montréal, University of Montreal, Montreal, Quebec, Canada 

Reprint requests: Deana Funaro, MD, Department of Dermatology, St-Luc Hospital, Centre Hospitalier de l'Université de Montréal, 1560 Sherbrooke St E, Montreal, Quebec H2L 4M1, Canada.

Vulvar lichen sclerosus is a chronic condition usually responsive to topical corticosteroids.


We sought to evaluate the efficacy (reduction of signs and symptoms) and safety of clobetasol propionate 0.05% and tacrolimus 0.1% in the treatment of vulvar lichen sclerosus.


This double-blind, randomized study comparing 2 treatments over a 3-month period, enrolled 58 female patients with newly diagnosed vulvar lichen sclerosus or untreated vulvar lichen sclerosus for at least 1 month.


In all, 55 patients were included in the statistical analysis. A total of 28 patients were assigned to the tacrolimus group and 27 patients to the clobetasol group. Both groups showed a significant difference in the decrease of symptoms and signs of lichen sclerosus. At the end of the study, 28 participants (19 tacrolimus and 9 clobetasol) still had some clinical signs of lichen sclerosus (χ2 = 6.56, P  = .015). However, a significantly higher number of patients in the clobetasol group (n = 15) had absence of signs and symptoms of lichen sclerosus (χ2 = 10.35, P  = .002; χ2 = 10.35, P  = .002). No adverse events were reported.


Short length of trial and recruitment through our vulvar disease referral center are limitations.


This study showed that topical clobetasol propionate was significantly more effective in treating vulvar lichen sclerosus than topical tacrolimus.

The full text of this article is available in PDF format.

Key words : anogenital, carcinoma, clobetasol propionate, lichen sclerosus, tacrolimus, topical calcineurin inhibitor, vulva

Abbreviations used : VAS, VAS-BP, VAS-PR

 Sponsored by an Astellas Pharma research grant for an investigator-initiated study.
 Disclosure: Dr Powell served on the advisory board for Astellas Pharma and Dr Funaro received from Astellas Pharma a grant for an investigator-initiated study and received a bursary in a research competition. Drs Lovett and Leroux have no conflicts of interest to declare.

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