Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus
Açar sözlər
Mücərrəd
Təsvir
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.
Tarixlər
| Son Doğrulandı: | 09/30/2014 |
| İlk təqdim: | 05/06/2010 |
| Təxmini qeydiyyat təqdim edildi: | 05/16/2010 |
| İlk Göndərmə: | 05/18/2010 |
| Son Yeniləmə Göndərildi: | 10/06/2014 |
| Son Yeniləmə Göndərildi: | 10/07/2014 |
| Həqiqi Təhsilin Başlama Tarixi: | 02/28/2011 |
| Təxmini İlkin Tamamlanma Tarixi: | 06/30/2014 |
| Təxmini İşin Tamamlanma Tarixi: | 06/30/2014 |
Vəziyyət və ya xəstəlik
Müdaxilə / müalicə
Drug: 1
Drug: 2
Faza
Qol Qrupları
| Qol | Müdaxilə / müalicə |
|---|---|
| Active Comparator: 1 Clobetasol propionate 0.05%, topical application, once daily about 2 g, during 12 weeks | Drug: 1 Topical application, once daily about 2 g, during 12 weeks |
| Experimental: 2 Progesterone 8%, topical application, once daily about 2 g, during 12 weeks | Drug: 2 Topical application, once daily about 2 g, during 12 weeks |
Uyğunluq Kriteriyaları
| Təhsil üçün uyğun yaşlar | 18 Years Üçün 18 Years |
| Təhsilə Uyğun Cinslər | Female |
| Sağlam Könüllüləri qəbul edir | Bəli |
| Kriteriyalar | 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) |
Nəticə
İlkin nəticə tədbirləri
1. Score of the characteristics of Lichen sclerosus based on vulvar efflorescences [at 12 weeks]
İkincili Nəticə Tədbirləri
1. Patient-reported symptoms [at baseline]
2. Quality of life [at baseline]
3. Adverse events [at baseline]
4. Patient-reported symptoms [at 6 weeks]
5. Patient-reported symptoms [at 12 weeks]
6. Patient-reported symptoms [at 18 weeks]
7. Patient-reported symptoms [at 24 weeks]
8. Quality of life [at 12 weeks]
9. Quality of life [at 24 weeks]
10. Adverse events [at 6 weeks]
11. Adverse events [at 12 weeks]
