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

Abstract

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 (χ(2) = 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 (χ(2) = 10.35, P = .002; χ(2) = 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.

• Authors: Deana Funaro, Audrey Lovett, Nathalie Leroux, Julie Powell
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 71 Issue 1 Pg. 84-91 (Jul 2014) ISSN: 1097-6787 [Electronic] United States
• PMID: 24704090 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

Chemical References

• Glucocorticoids
• Immunosuppressive Agents
• Ointments
• Clobetasol
• Tacrolimus

Topics

• Administration, Topical
• Adult
• Clobetasol (administration & dosage)
• Double-Blind Method
• Female
• Glucocorticoids (administration & dosage)
• Humans
• Immunosuppressive Agents (administration & dosage)
• Middle Aged
• Ointments
• Prospective Studies
• Tacrolimus (administration & dosage)
• Treatment Outcome
• Vulvar Lichen Sclerosus (drug therapy)