A Double Blind Phase II Study Comparing Safety and Efficacy of Tacrolimus Versus Topical Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, 2 years or older
- •Medical diagnosis of vulvar lichen sclerosus
- •Received no treatment during the last 4 weeks
排除标准
- •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
研究组 & 干预措施
Tacrolimus cream
干预措施: Tacrolimus cream (Drug)
Clobetasol cream
干预措施: Clobetasol cream (Drug)
结局指标
主要结局
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
时间窗: Comparison before the treatment and monthly for 3 months.
次要结局
- 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.)
研究者
Deana Funaro
Dermatologist
St. Justine's Hospital