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Clobetasol Versus Pimecrolimus for Vulvar Lichen Sclerosus

NCT00393263 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2014-05-12

No results posted yet for this study

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.

Conditions

  • Lichen Sclerosus

Interventions

DRUG

pimecrolimus and clobetasol

DRUG

clobetasol 0.05% cream

twice daily for three months

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Center for Vulvovaginal Disorders

    lead OTHER

Principal Investigators

  • Andrew T Goldstein, MD · Center for Vulvovaginal Disorders

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00393263 on ClinicalTrials.gov