Status:
COMPLETED
Clobetasol Versus Pimecrolimus for Vulvar Lichen Sclerosus
Lead Sponsor:
Center for Vulvovaginal Disorders
Collaborating Sponsors:
Novartis
Conditions:
Lichen Sclerosus
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 significa...
Detailed Description
Lichen sclerosus (LS) is a chronic cutaneous disorder affecting approximately one in seventy women. Presenting symptoms may include intense pruritis, pain, burning, and severe dyspareunia. The typical...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00393263
Start Date
October 1 2006
End Date
October 1 2009
Last Update
May 12 2014
Active Locations (1)
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1
Center for VulvoVaginal Disorders
Washington D.C., District of Columbia, United States, 21012