Randomized Single-blind Study on the Adherence to Treatment With Topical Methylprednisolone Aceponate (Advantan®) in Different Vehicles (AD-HERE)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Adherence to treatment
研究概览
简要总结
Untersuchung der Adhärenz zur topischen Standardtherapie bei Patienten mit chronischem Handekzem in Abhängigkeit von der Galenik
详细描述
Prospective, randomized, parallel grouped, single-blinded (investigator), monocentric objective assessment of the adherence to the treatment with topical methylprednisolone aceponate (Advantan®) depending on the type of vehicle in patients with hand eczema treated according to the current Guideline.
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
- Double (Care Provider, Investigator)
盲法说明
The investigator of the study will not know in which vehicle the enrolled patient will receive the standard therapeutical drug
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent has been obtained.
- •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).
- •Subjects (male or female) aged from 18 to 65 years.
- •In overall good health including well controlled diseases as determined by medical history, physical examination, vital signs and clinical laboratory.
- •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 enrolment and until the last visit (V3).
- •Female subjects must not be breastfeeding.
排除标准
- •females who are 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 antibiotics 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 in 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 Pharma A/S or Bayer Consumer Care AG or subject is an employee of sponsor.
研究组 & 干预措施
cream
Treatment with topical Methylprednisolone aceponate 0,1% cream (Advantan®) plus Basic care (Bepanthen® Sensiderm)
干预措施: Adherence to topical standard therapy assessed (Behavioral)
fatty ointment
Treatment with topical Methylprednisolone aceponate 0,1% fatty ointment (Advantan®) plus Basic care (Bepanthen® Sensiderm)
干预措施: Adherence to topical standard therapy assessed (Behavioral)
结局指标
主要结局
Adherence to treatment
时间窗: 28 days
Adherence defined as percentage of patients applying at least aimed daily dose Adherence will be assumed, if * truly applicated daily dose is at least 75% of prescribed daily dose and * the individual mean number of applications per day is at least 0.85
Measurement 1
时间窗: 28 days; visit 1 (day 1)
Hand surface \[cm²\]
Individual amount of topical drug
时间窗: 28 days
- weight of topical drug container \[mg\] by hand surface \[cm²\] will be combined to individual amount of topical drug which will as well be the prescribed daily dose
Truly applicated daily dose
时间窗: 28 days
- individual amount of topical drug used \[mg/cm²\] by individual mean number of applications
Measurement 2
时间窗: 28 days; visit 1 (day 1), 2 (day 14) and 3 (day 28)
Weight of topical drug container \[mg\]
次要结局
- Change of Hand Eczema(28 days; visit 1 (day 1), 2 (day 14) and 3 (day 28))
研究者
Peter Elsner
Prof. Dr. med. P. Elsner, Head of Dermatology, Principal Investigator
Jena University Hospital