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.