Clobetasol Versus Pimecrolimus for Vulvar Lichen Sclerosus
Primary Purpose
Lichen Sclerosus
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pimecrolimus and clobetasol
clobetasol 0.05% cream
Sponsored by
About this trial
This is an interventional treatment trial for Lichen Sclerosus
Eligibility Criteria
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.
Sites / Locations
- Center for VulvoVaginal Disorders
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
pimecrolimus
clobetasol
Outcomes
Primary Outcome Measures
Change in inflammation
Secondary Outcome Measures
Pruritus
Burning
Pain
Lichenification
Full Information
NCT ID
NCT00393263
First Posted
October 25, 2006
Last Updated
May 8, 2014
Sponsor
Center for Vulvovaginal Disorders
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00393263
Brief Title
Clobetasol Versus Pimecrolimus for Vulvar Lichen Sclerosus
Official Title
A Double-Blind, Parallel-group Trial of Topical Pimecrolimus Cream 1% (Elidel®) Versus Clobetasol 0.05% Cream for the Treatment of Vulvar Lichen Sclerosus
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Center for Vulvovaginal Disorders
Collaborators
Novartis
4. Oversight
5. Study Description
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.
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 0.05% cream) for the treatment for vulvar LS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lichen Sclerosus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
pimecrolimus
Arm Title
2
Arm Type
Active Comparator
Arm Description
clobetasol
Intervention Type
Drug
Intervention Name(s)
pimecrolimus and clobetasol
Intervention Type
Drug
Intervention Name(s)
clobetasol 0.05% cream
Intervention Description
twice daily for three months
Primary Outcome Measure Information:
Title
Change in inflammation
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Pruritus
Time Frame
3 months
Title
Burning
Time Frame
3 months
Title
Pain
Time Frame
3 months
Title
Lichenification
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew T Goldstein, MD
Organizational Affiliation
Center for Vulvovaginal Disorders
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for VulvoVaginal Disorders
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
21012
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15568399
Citation
Goldstein AT, Marinoff SC, Christopher K. Pimecrolimus for the treatment of vulvar lichen sclerosus: a report of 4 cases. J Reprod Med. 2004 Oct;49(10):778-80.
Results Reference
result
PubMed Identifier
21353334
Citation
Goldstein AT, Creasey A, Pfau R, Phillips D, Burrows LJ. A double-blind, randomized controlled trial of clobetasol versus pimecrolimus in patients with vulvar lichen sclerosus. J Am Acad Dermatol. 2011 Jun;64(6):e99-104. doi: 10.1016/j.jaad.2010.06.011. Epub 2011 Feb 25.
Results Reference
result
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Clobetasol Versus Pimecrolimus for Vulvar Lichen Sclerosus
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