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Trial record 2 of 5 for:    "Lichen sclerosis"

Clobetasol Versus Pimecrolimus for Vulvar Lichen Sclerosus

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Andrew T. Goldstein, MD, Center for Vulvovaginal Disorders
ClinicalTrials.gov Identifier:
NCT00393263
First received: October 25, 2006
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Lichen Sclerosus
Drug: pimecrolimus and clobetasol
Drug: clobetasol 0.05% cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Center for Vulvovaginal Disorders:

Primary Outcome Measures:
  • Change in inflammation [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pruritus [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Burning [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Lichenification [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: October 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
pimecrolimus
Drug: pimecrolimus and clobetasol
Active Comparator: 2
clobetasol
Drug: clobetasol 0.05% cream
twice daily for three months

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393263

Locations
United States, District of Columbia
Center for VulvoVaginal Disorders
Washington, District of Columbia, United States, 21012
Sponsors and Collaborators
Center for Vulvovaginal Disorders
Novartis
Investigators
Principal Investigator: Andrew T Goldstein, MD Center for Vulvovaginal Disorders
  More Information

Publications:
Responsible Party: Andrew T. Goldstein, MD, Director, Center for Vulvovaginal Disorders
ClinicalTrials.gov Identifier: NCT00393263     History of Changes
Other Study ID Numbers: CASM981C US40
Study First Received: October 25, 2006
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lichen Sclerosus et Atrophicus
Vulvar Lichen Sclerosus
Genital Diseases, Female
Lichenoid Eruptions
Skin Diseases
Skin Diseases, Papulosquamous
Vulvar Diseases
Clobetasol
Pimecrolimus
Tacrolimus
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014