Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00393263
Status:
COMPLETED
Last Update Posted:
2014-05-12
First Post:
2006-10-25
Brief Title:
Clobetasol Versus Pimecrolimus for Vulvar Lichen Sclerosus
Sponsor:
Center for Vulvovaginal Disorders
Organization:
Center for Vulvovaginal Disorders
Study Overview
Official Title:
A Double-Blind Parallel-group Trial of Topical Pimecrolimus Cream 1 Elidel Versus Clobetasol 005 Cream for the Treatment of Vulvar Lichen Sclerosus
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 lesions of LS are white plaques and papules often with areas of echymosis excoriation and ulceration Often LS causes destruction of the vulva architecture In addition 4-6 percent of women with LS will develop vulvar carcinoma The histopathologic changes of LS are distinctive and make biopsy a very useful diagnostic tool While there is no known cure for LS the current gold standard treatment is ultra-potent corticosteroids When properly administered topical ultra-potent corticosteroids help to resolve the symptoms of pruritis and burning and can prevent further vulvar scarring In addition proper treatment reverses the underlying histopathologic changes of LS and preliminary data shows that the risk of malignant transformation also declines Although treatment with topical corticosteroids is effective topical corticosteroids have serious local and systemic side effects including dermal thinning skin atrophy superimposed fungal infections rebound dermatitis and adrenal insufficiency
Pimecrolimus cream 1 Elidel Novartis Pharmaceutical is a topical calcineurin inhibitor that binds to macrophilin-12 and inhibits cytokine synthesis by T lymphocytes Elidel has been approved by the FDA for the treatment of mild to moderate atopic dermatitis In theory as Elidel inhibits T lymphocytes it should effectively treat lichen sclerosus In addition as Elidel does not inhibit keratinocytes or affect collagen synthesis it does not cause dermal atrophy Therefore Elidel may be an effective and safer alternative treatment for LS This study is designed to compare the effectiveness and safety of Elidel 1 cream versus an ultra-potent corticosteroid clobetasol 005 cream for the treatment for vulvar LS
Pimecrolimus cream 1 Elidel Novartis Pharmaceutical is a topical calcineurin inhibitor that binds to macrophilin-12 and inhibits cytokine synthesis by T lymphocytes Elidel has been approved by the FDA for the treatment of mild to moderate atopic dermatitis In theory as Elidel inhibits T lymphocytes it should effectively treat lichen sclerosus In addition as Elidel does not inhibit keratinocytes or affect collagen synthesis it does not cause dermal atrophy Therefore Elidel may be an effective and safer alternative treatment for LS This study is designed to compare the effectiveness and safety of Elidel 1 cream versus an ultra-potent corticosteroid clobetasol 005 cream for the treatment for vulvar LS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None