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

J Am Acad Dermatol. 2014 Jul;71(1):84-91. doi: 10.1016/j.jaad.2014.02.019. Epub 2014 Apr 3.


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.

Keywords: anogenital; carcinoma; clobetasol propionate; lichen sclerosus; tacrolimus; topical calcineurin inhibitor; vulva.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 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*


  • Glucocorticoids
  • Immunosuppressive Agents
  • Ointments
  • Clobetasol
  • Tacrolimus