Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus

A Double Blind Phase II Study Comparing Safety and Efficacy of Tacrolimus Versus Topical Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus.

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.

Study Overview

• Status: Completed
• Conditions: Vulvar Lichen Sclerosus
• Intervention / Treatment: Drug: Tacrolimus cream; Drug: Clobetasol cream

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tacrolimus cream	Drug: Tacrolimus cream; 0.5 g per day at bed time for 3 months or less.; Other Names: Prtopic
Active Comparator: Clobetasol cream	Drug: Clobetasol cream; 0.5 gram each day at bed time during 3 months or less.; Other Names: Dermovate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Comparison before the treatment and monthly for 3 months.

Secondary Outcome Measures

Outcome Measure	Time Frame
Compared presence and severity of side effects of both groups.	During the 3 months of treatment
CBC, Glycemia, vitamine B 12 dosage, TSH (to find associated auto-immune diseases)	At 1 to 3 months after starting the study, collected once.

Collaborators and Investigators

• Sponsor: Deana Funaro
• Collaborators: Astellas Pharma Inc
• Investigators: Principal Investigator: Deana Funaro, Doctor, St. Justine's Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: September 22, 2008
• First Submitted That Met QC Criteria: September 22, 2008
• First Posted (Estimate): September 23, 2008

Study Record Updates

• Last Update Posted (Estimate): September 9, 2015
• Last Update Submitted That Met QC Criteria: September 5, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Female urogenital disease; skin disease
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Vulvar Diseases; Lichenoid Eruptions; Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Calcineurin Inhibitors; Tacrolimus; Clobetasol
• Other Study ID Numbers: StJustineH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No