Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus

This study has been completed.
Astellas Pharma Inc
Information provided by (Responsible Party):
Deana Funaro, St. Justine's Hospital
ClinicalTrials.gov Identifier:
First received: September 22, 2008
Last updated: September 5, 2015
Last verified: September 2015

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 2

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:

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 ]

Enrollment: 56
Study Start Date: April 2006
Study Completion Date: January 2010
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


Ages Eligible for Study:   2 Years and older
Genders 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00757874

Canada, Quebec
CHU Sainte-Justine
Montreal, Quebec, Canada, H3P 3N5
Sponsors and Collaborators
Deana Funaro
Astellas Pharma Inc
Principal Investigator: Deana Funaro, Doctor St. Justine's Hospital
  More Information

Responsible Party: Deana Funaro, Dermatologist, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT00757874     History of Changes
Other Study ID Numbers: StJustineH 
Study First Received: September 22, 2008
Last Updated: September 5, 2015
Health Authority: Canada: Health Canada

Keywords provided by St. Justine's Hospital:
Female urogenital disease
skin disease

Additional relevant MeSH terms:
Lichen Sclerosus et Atrophicus
Vulvar Lichen Sclerosus
Genital Diseases, Female
Lichenoid Eruptions
Skin Diseases
Skin Diseases, Papulosquamous
Vulvar Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016