A double-blind, randomized prospective study evaluating topical clobetasol propionate 0.05% versus topical tacrolimus 0.1% in patients with vulvar lichen sclerosus - 18/06/14
, Audrey Lovett, MD d, Nathalie Leroux, MD c, Julie Powell, MD aAbstract |
Background |
Vulvar lichen sclerosus is a chronic condition usually responsive to topical corticosteroids.
Objective |
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.
Method |
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.
Results |
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.
Limitations |
Short length of trial and recruitment through our vulvar disease referral center are limitations.
Conclusion |
This study showed that topical clobetasol propionate was significantly more effective in treating vulvar lichen sclerosus than topical tacrolimus.
Le texte complet de cet article est disponible en PDF.Key words : anogenital, carcinoma, clobetasol propionate, lichen sclerosus, tacrolimus, topical calcineurin inhibitor, vulva
Abbreviations used : VAS, VAS-BP, VAS-PR
Plan
| Sponsored by an Astellas Pharma research grant for an investigator-initiated study. |
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| 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. |
Vol 71 - N° 1
P. 84-91 - juillet 2014 Retour au numéro
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