Clobetasol Versus Pimecrolimus for Vulvar Lichen Sclerosus
Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
Participant gender:
Summary
Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS
causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which
may cause significant sexual dysfunction or pain. Lastly, 4-6% of women with LS will develop
vulvar cancer.
The current "gold standard" treatment for lichen sclerosus is ultra-potent topical
corticosteroids. When properly administered, topical ultra-potent corticosteroids help to
resolve the symptoms of itching and burning and can prevent further vulvar scarring. In
addition, proper treatment reverses the underlying inflammation of LS, and preliminary data
shows that the risk of cancer also declines. While effective, topical corticosteroids have
serious local and systemic side effects that include thinning of the skin, superimposed
fungal infections, and suppression of the adrenal gland.
Elidel 1% cream is a new type of medication that has been approved by the FDA for the
treatment of eczema. In theory, Elidel should also treat LS without the serious side effects
that accompany corticosteroids. Therefore, this study is designed to compare the
effectiveness and safety of a topical corticosteroid (clobetasol) versus Elidel 1% cream for
the treatment of LS.