Inclusion Criteria:

• Female, 18 years or older.
• With a diagnosis of biopsy proven active vulvar lichen sclerosus.
• Signed written informed consent.
• Willingness and ability to comply with the study requirements.
• Negative urine pregnancy tests must be documented for all females of childbearing potential prior to enrollment.
• Two forms of birth control will be required for women with childbearing potential.
• IGA at baseline ≥1
• Subjects must have ≥ 4 or greater (on a 0 to 10 point scale) on at least one of the two visual analog scales (pruritus or pain/burning).

Exclusion Criteria:

• Who have received systemic immunosuppressants (e.g. corticosteroids) within 4 weeks prior to participation in the study.
• Who have been treated with topical therapy (e.g., topical corticosteroids, pimecrolimus, and tacrolimus) at the affected area within two weeks prior to participation in the study.
• Who are immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease.
• Who have a history of lymphoma
• Who have lympadenopathy
• Who have active vulvar herpes, molluscum, or condyloma
• Who suffer from systemic or generalized infections (bacterial, viral or fungal).
• Who have been diagnosed with lichen planus, psoriasis, candidiasis, intraepithelial neoplasia, or carcinoma of the vulva.
• Who have been diagnosed with diabetes mellitus or Netherton’s syndrome.
• Menstruating females of childbearing potential who are not using two medically accepted methods of contraception during the study. Medically approved contraception may, at the discretion of the investigator, include abstinence.
• Women who are breastfeeding.
• Who had received an investigational drug within four weeks prior to the study or who intend to use other investigational drugs during the course of this study.
• Who are hypersensitive to pimecrolimus or clobetasol or any of the components of the creams.
• Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
• Who have a history of substance abuse or any factor, which limits the subject’s ability to cooperate with the study procedures.
• Who are uncooperative, known to miss appointments (according to subjects’ records) and are unlikely to follow medical instructions or are not willing to attend regularly scheduled visits.