Vulvar Lichen Sclerosus
Conditions
Keywords
Female urogenital disease, skin disease
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.
Interventions
DRUGTacrolimus cream
0.5 g per day at bed time for 3 months or less.
DRUGClobetasol cream
0.5 gram each day at bed time during 3 months or less.
Sponsors
Astellas Pharma Inc
Deana Funaro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
2 Years to No maximum
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
Design outcomes
Primary
| 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
| 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. |
Countries
Canada
Outcome results
None listed