Clobetasol Versus Pimecrolimus for Vulvar Lichen Sclerosus

NCT00393263 | Completed Phase 2

• 1 other identifier: CASM981C US40
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Lichen Sclerosus

Outcome Measures

Primary Outcomes (1)

• Change in inflammation

  3 months

Secondary Outcomes (4)

• Pruritus

  3 months

• Burning

  3 months

• Pain

  3 months

• Lichenification

  3 months

Study Arms (2)

1

EXPERIMENTAL

pimecrolimus

Drug: pimecrolimus and clobetasol

2

ACTIVE COMPARATOR

clobetasol

Drug: clobetasol 0.05% cream

Interventions

pimecrolimus and clobetasol DRUG

1

clobetasol 0.05% cream DRUG

twice daily for three months

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center for Vulvovaginal Disorders: lead
• Novartis: collaborator

Study Sites (1)

Center for VulvoVaginal Disorders

Washington D.C., District of Columbia, 21012, United States

Location

Related Publications (2)

• 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.

  PMID: 15568399 RESULT

• 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.

  PMID: 21353334 RESULT

MeSH Terms

Conditions

Lichen Sclerosus et Atrophicus

Interventions

pimecrolimus; Clobetasol

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Andrew T Goldstein, MD

  Center for Vulvovaginal Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 25, 2006
• First Posted: October 27, 2006
• Study Start: October 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: May 12, 2014

Record last verified: 2014-05

Locations

US (1)