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Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00757874
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : September 9, 2015
Astellas Pharma Inc
Information provided by (Responsible Party):
Deana Funaro, St. Justine's Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Vulvar Lichen Sclerosus Drug: Tacrolimus cream Drug: Clobetasol cream Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
Study Start Date : April 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Compared presence and severity of side effects of both groups. [ Time Frame: During the 3 months of treatment ]
  2. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00757874

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Canada, Quebec
CHU Sainte-Justine
Montreal, Quebec, Canada, H3P 3N5
Sponsors and Collaborators
Deana Funaro
Astellas Pharma Inc
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Principal Investigator: Deana Funaro, Doctor St. Justine's Hospital
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Responsible Party: Deana Funaro, Dermatologist, St. Justine's Hospital Identifier: NCT00757874    
Other Study ID Numbers: StJustineH
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015
Keywords provided by Deana Funaro, St. Justine's Hospital:
Female urogenital disease
skin disease
Additional relevant MeSH terms:
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Vulvar Lichen Sclerosus
Lichen Sclerosus et Atrophicus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Vulvar Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists