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NCT Number: NCT00757874

Tacrolimus Versus 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.

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Key information

Conditions

Vulvar Lichen Sclerosus Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Vulvar Diseases

Age range

2 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

CHU Sainte-Justine

Montreal, Quebec, H3P 3N5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus cream

Drug

0.5 g per day at bed time for 3 months or less.

Other names: Prtopic

Clobetasol cream

Drug

0.5 gram each day at bed time during 3 months or less.

Other names: Dermovate

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Deana Funaro

Other

Collaborators

  • Astellas Pharma Inc

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Sep 23, 2008
Registry last updated
Sep 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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