EUCTR2015-004298-33-IT进行中（未招募）1 期
First randomized trial on clobetasol propionate 0.05% and betamethasone dipropionate 0.05% plus salicilic acid 3% in the treatment of vulvar lichen sclerosus: comparison of efficacy and tolerability - LiSA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •oFemale, 18 years or older, menopausal ascertained (amenorrea for 1 year or more)
- •oA diagnosis of biopsy proven vulvar lichen sclerosus.
- •oSigned written informed consent.
- •oWillingness and ability to comply with the study requirements.
- •oIGA at baseline =1
- •oSubjects must have = 4 or greater (on a 0 to 10 point scale) on at least one of the two visual analog scales (pruritus or pain/burning).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •oWho have received systemic immunosuppressants (e.g. corticosteroids) or hormonal therapies within 6 months prior to participation in the study.
- •oWho have been treated with topical therapy (e.g., topical corticosteroids, pimecrolimus, and tacrolimus) at the affected area within 6 months prior to participation in the study.
- •oWho are immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease, as known data or previous
- •oWho have a history of lymphoma or lympadenopathy
- •oWho have active vulvar herpes, molluscum, or condyloma or systemic or generalized infections (bacterial, viral or fungal). Who have been diagnosed with lichen planus, psoriasis, candidiasis, intraepithelial neoplasia, or carcinoma of the vulva.
- •oMenstruating females of childbearing age
- •oWho had received an investigational drug within 6 months prior to the study or who intend to use other investigational drugs during the course of this study.
- •oWho are hypersensitive to clobetasol propionate 0.05% or betamethasone dipropionate 0.05% plus salicilic acid 3% or any of the components of the creams.
- •oPatients with severe medical condition(s) that in the view of the investigator prohibits participation in the study, as reported in RCP.
- •oWho have a history of substance abuse or any factor, which limits the subject’s ability to cooperate with the study procedures.
- •oWho are uncooperative, known to miss appointments (according to subjects’ records) and are unlikely to follow medical instructions or are not willing to attend regularly scheduled visits.
- •o Who are treated, as reported in RCP
研究者
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