Efficacy of a Topic Therapy With Progesterone Compared to the Conventional Therapy With Clobetasol Propionate in Patients With Vulvar Lichen Sclerosus. A Double Blind, Randomized Phase II Pilot Study.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Score of the characteristics of Lichen sclerosus based on vulvar efflorescences
研究概览
简要总结
This is a randomized trial comparing progesterone with conventional clobetasol propionate in patients with vulvar lichen sclerosus.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- 未提供
研究组 & 干预措施
1
Clobetasol propionate 0.05%, topical application, once daily about 2 g, during 12 weeks
干预措施: Clobetasol propionate 0.05% (Drug)
2
Progesterone 8%, topical application, once daily about 2 g, during 12 weeks
干预措施: Progesterone 8% (Drug)
结局指标
主要结局
Score of the characteristics of Lichen sclerosus based on vulvar efflorescences
时间窗: 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).
次要结局
- Quality of life(at 24 weeks)
- Adverse events(at 12 weeks)
- Patient-reported symptoms(at 24 weeks)