CTIS2022-503011-42-00招募中1 期
Treatment of Chronic Hand Eczema with Oral Roflumilast (HERO) – a randomized controlled trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Age = 18 years, Age = 75 years, HECSI = 18 (moderate to severe hand eczema), IGA-CHE = 3, Body mass index (BMI) = 20 kg/m2, Negative pregnancy test (only women of child-bearing potential (see section 2.8)), Willing to use safe anticonception during entire study and at least 1 week after end of treatment (?5 times plasma half-life of Roflumilast). This only account for women child-bearing potential, Speaks, understands, and reads danish
排除标准
- •Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis, Current treatment with topical antibiotics at screening, Diagnosis of contact eczema of clinical significance 3 months before randomization, Previous treatment with apremilast (Otezla®) or roflumilast (Daxas®), Confirmed pregnancy, Breast feeding, Blood donation during study, Allergy to roflumilast or any other PDE-4 inhibitor, Diagnosis of current tuberculosis, Current viral hepatitis, History of heart failure (NYHA III-IV), History of moderate or severe liver failure (Child-Pugh B-C), Current or former depression with suicidal ideation, Topical therapy (anti-inflammatory) for chronic hand eczema 14 days before randomization (wash-out period) and during study after week 4, Systemic therapy for chronic hand eczema 28 days before randomization (wash-out period) and during study, Current treatment with oral dicloxacillin or macrolide at screening
研究者
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