Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus - Full Text View

Sponsor:	St. Justine's Hospital
Information provided by:	St. Justine's Hospital
ClinicalTrials.gov Identifier:	NCT00757874

Purpose

Lichen Sclerosus is an inflammatory skin condition affecting mostly the genital area of persons of all ages, gender or race. The most frequent complaint is that of itchiness of the vulva but pain may also occur. Some women will experience no symptoms at all. However, it is important to treat this condition since it may increase and cause important scarring and deformity. In less than 5% of cases, cancer may develop.

Lichen Sclerosus is a chronic disease which can be controlled but not cured. Topical corticosteroids are the usual treatment for this condition. Though this treatment is generally well tolerated, some patients may not present a sufficient response or may develop mainly local and rarely systemic side effects. In this perspective, an alternative treatment would be beneficial.

Tacrolimus, a topical immunomodulator has been approved for the treatment of atopic eczema and has shown its efficacy in the treatment of vulvar lichen sclerosus in a limited number of patients. Tacrolimus acts as a non-steroidal anti-inflammatory agent (NSAI) without causing the usual side effects seen with the prolonged use of topical corticosteroids.

This study is designed to evaluate the safety and efficacy of tacrolimus in treating vulvar lichen sclerosus by comparing it with the standard topical corticosteroid treatment.

Condition	Intervention	Phase
Vulvar Lichen Sclerosus	Drug: Tacrolimus cream Drug: Clobetasol cream	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Double Blind Phase II Study Comparing Safety and Efficacy of Tacrolimus Versus Topical Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus.

Resource links provided by NLM:

MedlinePlus related topics: Skin Conditions

Drug Information available for: Clobetasol Clobetasol propionate Tacrolimus anhydrous Tacrolimus

U.S. FDA Resources

Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:

To document the efficacy of Tacrolimus vs topical clobetasol propionate in the treatment of Vulvar Lichen Sclerosus by medical examinations and reporting of the symptoms. Cream is applied once a day for 3 months [ Time Frame: Comparison before the treatment and monthly for 3 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compared presence and severity of side effects of both groups. [ Time Frame: During the 3 months of treatment ] [ Designated as safety issue: Yes ]
CBC, Glycemia, vitamine B 12 dosage, TSH (to find associated auto-immune diseases) [ Time Frame: At 1 to 3 months after starting the study, collected once. ] [ Designated as safety issue: No ]

Estimated Enrollment:	56
Study Start Date:	April 2006
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Tacrolimus cream	Drug: Tacrolimus cream 0.5 g per day at bed time for 3 months or less. Other Name: Prtopic
Active Comparator: Clobetasol cream	Drug: Clobetasol cream 0.5 gram each day at bed time during 3 months or less. Other Name: Dermovate

Eligibility

Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female, 2 years or older
Medical diagnosis of vulvar lichen sclerosus
Received no treatment during the last 4 weeks

Exclusion Criteria:

Who have received topical steroids, tacrolimus or pimecrolimus during the 4 last weeks.
Who are immunocompromised
Who have history of intra-epithelial neoplasia or anogenital carcinoma
Who have active vulvar infections (herpes,condylomas,vaginitis)
Who are hypersensitive to tacrolimus, pimecrolimus or corticosteroids
Who have physical limitations that cause difficulty in applying the cream
Who wear diapers
Who present Hyperkeratotic Vulvar Lichen Sclerosus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757874

Locations

Canada, Quebec
CHU Sainte-Justine
Montreal, Quebec, Canada, H3P 3N5

Sponsors and Collaborators

St. Justine's Hospital

Investigators

Principal Investigator:

Deana Funaro, Doctor

St. Justine's Hospital

More Information

No publications provided

Responsible Party:	Deana Funaro, CHU Sainte-Justine
ClinicalTrials.gov Identifier:	NCT00757874 History of Changes
Other Study ID Numbers:	StJustineH
Study First Received:	September 22, 2008
Last Updated:	September 17, 2009
Health Authority:	Canada: Health Canada

Keywords provided by St. Justine's Hospital:

Female urogenital disease
skin disease

Additional relevant MeSH terms:

Vulvar Lichen Sclerosus
Lichen Sclerosus et Atrophicus
Vulvar Diseases
Genital Diseases, Female
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Clobetasol
Tacrolimus

Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on February 09, 2012