Lichen sclerosus (LS) is a common autoimmune disease of the genital skin. It affects 1/900
women with an age peak in the sixth decade of life and is manifested by chronic inflammation
of the genital, perineal, and perianal areas associated with itching, burning, pain, and
soreness. In addition, LS is associated with an increased risk of vulvar cancer.
Treatment options for LS include topical steroids such as clobetasol, immunomodulators such
as tacrolimus, and non-ablative laser treatment. Although both treatments are well documented
and used in clinical practice, direct comparative studies of the efficacy of topical
corticosteroids versus laser treatment in women with LS are rare. For example, a PubMed
literature search (search date 2021-03-14; search terms: lichen sclerosus, laser,
corticosteroids, steroids, clobetasol, randomized) identified only a single randomized trial
with limited power.
Given the available evidence, further high-quality studies are needed to define the
superiority/inferiority of the different available treatment options such as nonablative
lasers and topical corticosteroids.
Therefore, in this prospective, randomized, open-label, comparative study, treatment success
after 3 courses of non-ablative treatment with CO2 laser every 14 days will be compared with
treatment success after topical application of clobetasol 0.05% over 3 months (daily in the
first month, every other day in month 2, and 3 times/week during month 3) at the time point 3
months after treatment initiation.