Vulvar Lichen Sclerosus
Conditions
Keywords
vulvar lichen sclerosus, progesterone, clobetasol, randomized controlled trial
Brief summary
This is a randomized trial comparing progesterone with conventional clobetasol propionate in patients with vulvar lichen sclerosus.
Detailed description
Background A total of 62 female patients with first diagnosis of lichen sclerosus will be treated daily with either topical progesterone 8% or clobetasol propionate 0.05% for 12 weeks. Response to the treatment will be evaluated by macroscopic description of the dermatologic phenotype by using a specific lichen sclerosus score and photography-documentation. The symptoms and quality of life of the patients will be evaluated by standardized questionnaires. Additionally, tissue samples will be taken before and again after 12 weeks of treatment to evaluate the response status. Objective The purpose of this study is to compare progesterone with conventional clobetasol propionate in a superiority trial. Methods Prospective, randomized, controlled, superiority phase II pilot trial. Patients will be randomized 1:1 to either progesterone or clobetasol propionate, with patients, physicians, assessors and analysts being blinded.
Interventions
Topical application, once daily about 2 g, during 12 weeks
DRUGProgesterone 8%
Topical application, once daily about 2 g, during 12 weeks
Sponsors
University of Bern
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Consent to biopsy at start and end of therapy * Suspicion of Lichen sclerosus * Pre-menopausal * Age ≥18 years
Exclusion criteria
* Prior surgery at the vulva, with exception of episiotomy * Pregnancy * Signs of infection with human papilloma virus at the vulva * Vulvar intraepithelial neoplasia (VIN) * Known generalised autoimmune disease * Lichen sclerosus since childhood * Prior therapy with topic clobetasol propionate or other immunosuppressives (tacrolimus or pimecrolimus) at the vulva * Atopic diathesis and/or contact allergy * Systemic immunosuppressive therapy * Genital infection within the last four weeks (eg., condyloma acuminata, candidiasis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score of the characteristics of Lichen sclerosus based on vulvar efflorescences | at 12 weeks | The severity of the Lichen sclerosus will be assessed by a metric score, which is based on 6 items (abrasion, hyperkeratosis, rhagades, synechia, sclerosis, atrophy of labia/clitoris) consisting of three levels (0=no signs, 1=few signs, 2=pronounced signs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported symptoms | at baseline | The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore. |
| Quality of life | at baseline | The patient will report quality of life on the SF12 questionnaire. |
| Adverse events | at baseline | The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application. |
Countries
Switzerland
Outcome results
None listed