EUCTR2019-001324-35-DE进行中（未招募）1 期
Randomized single-blind study on the adherence to treatment with topical methylprednisolone aceponate (Advantan®) in different vehicles (AD-HERE) - AD-HERE
Friedrich-Schiller-University Jena0 个研究点目标入组 80 人开始时间: 2019年9月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- All
入选标准
- •1. Signed and dated informed consent has been obtained.
- •2. Clinical diagnosis of chronic mild-to-moderate hand dermatitis with or without atopic etiology or background (according to IGA: at least mild at Visit 1).
- •3. Subject(male or female) aged from 18 to 65 years.
- •4. In overall good health including well controlled diseases as determined by medical history, physical examination, vital signs and clinical laboratory.
- •5. Female subjects must be of either:
- •non-childbearing potential, post-menopausal, or have a confirmed clinical history of sterility or,
- •childbearing potential, provided there is a confirmed negative urine pregnancy test prior to exposure, to rule out pregnancy
- •Female subjects of childbearing potential must be willing to use highly effective methods of contraception to avoid causing pregnancy from enrollment and until the last visit (V3).
- •Female subjects must not be breastfeeding.
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •female who is pregnant or breast-feeding
- •Systemic treatment with immunosuppressive drugs, retinoids or corticosteroids within 8 weeks prior to randomization.
- •Phototherapy (PUVA or UVB) on the hands within 4 weeks prior to randomization.
- •Topical applied treatment with immunomodulators (e.g. pimecrolimus or tacrolimus) or corticosteroids on the hands within 2 weeks prior to randomization.
- •Use of other treatment on the hands during the clinical trial except for the use of investigational medicinal product (IMP) and emollient provided by sponsor during the clinical trial.
- •Use of systemic antobiotics or cutaneously applied antibiotics on the hands within 2 weeks prior to randomization.
- •Concurrent skin diseases on the Hands and/or Integument with acute flare and/or Skin lesions within the last 8 weeks.
- •Current diagnosis of eczema on the integument except for the hands.
- •Current diagnosis of exfoliative dermatitis.
- •Current diagnosis of glaucoma or cataract.
- •Significant clinical infection on the hands which requires antibiotic treatment.
- •Known or suspected hypersensitivity to component(s) of the IMP.
- •Subjects with history of an immunocompromising disease (e.g. lymphoma, HIV).
- •Former participation on this clinical trial.
- •Current participation in any other interventional clinical trial.
- •Subjects known or, in the opinion of the investigator, are unlikely to comply with the Clinical Trial Protocol (e.g. alcoholism, drug dependency or psychotic state).
- •Close affiliation with the investigator or other employees of the trial site (e.g. a close relative) or persons working at LEO PharmaA/S or Bayer Consumer Care AG or subject is an employee of Klinik für Hautkrankheiten Jena.
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