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NCT00393263 · ClinicalTrials.gov registry record · Phase 2
Clobetasol Versus Pimecrolimus for Vulvar Lichen Sclerosus
A Phase 2 study, sponsored by Center for Vulvovaginal Disorders.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
NCT00393263 is a Phase 2 study that has completed, run by Center for Vulvovaginal Disorders. The registered enrollment target is 38 participants.
The verdict
NCT00393263, a Phase 2 study, has completed, sponsored by Center for Vulvovaginal Disorders.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
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.
Interventions
- DRUG pimecrolimus and clobetasol
- DRUG clobetasol 0.05% cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2006-10 |
| Est. Completion | 2009-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00393263
The ClinicalTrials.gov registry entry for NCT00393263 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Center for Vulvovaginal Disorders, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which pimecrolimus and clobetasol is the first listed.
NCT00393263 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00393263 about?
NCT00393263 is a clinical study titled "Clobetasol Versus Pimecrolimus for Vulvar Lichen Sclerosus". 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 curren...
What is the current status of trial NCT00393263?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2006-10. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00393263?
The interventions under investigation include: pimecrolimus and clobetasol (DRUG), clobetasol 0.05% cream (DRUG).
Who is sponsoring clinical trial NCT00393263?
This trial is sponsored by Center for Vulvovaginal Disorders, which has 6 total clinical trials registered on ClinicalTrials.gov.
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