NCT02664805已完成2 期
A Phase 2a, Proof of Concept Trial, Testing Twice Daily Applications of LEO 124249 Ointment in the Treatment of Chronic Hand Eczema
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Subjects with treatment success according to Physician's Global Assessment (PGA) at visit 6 (End of Treatment)
研究概览
简要总结
To compare the efficacy of twice daily applications of LEO 124249 ointment with LEO 124249 ointment vehicle for up to 8 weeks in the treatment of subjects with chronic hand eczema.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Clinical diagnosis of chronic hand eczema with or without atopic etiology/background with a history of not adequately controlled disease activity with cutaneously applied steroid
- •Physician's Global Assessment of disease severity graded as at least mild at Visit 1
- •In overall good health including well controlled diseases
排除标准
- •Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), retinoids (e.g. alitretinoin) or corticosteroids within 6 weeks prior to randomization (inhaled or intra-nasal steroids corresponding to up to 1 mg prednisone for asthma or rhinitis may be used).
- •PUVA (Psoralen Ultraviolet A) or UVB (Ultraviolet B) therapy on the hands within 4 weeks prior to randomization
- •Cutaneously applied treatment with immunomodulators (pimecrolimus, tacrolimus) or corticosteroids on the hands within 2 weeks prior to randomization.
- •Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2 weeks prior to randomization
- •Concurrent skin diseases on the hands
- •Current diagnosis of exfoliative dermatitis
- •Significant clinical infection (impetiginized hand eczema) on the hands which requires antibiotic treatment
- •A marked abnormal ECG at baseline
- •Known hepatic dysfunction or hepatic dysfunction tested at Screening
- •Current participation in any other interventional clinical trial
研究组 & 干预措施
LEO 124249 ointment
Active Comparator
Twice daily cutaneous application for 8 weeks
干预措施: LEO 124249 ointment (Drug)
LEO 124249 ointment vehicle
Placebo Comparator
Twice daily cutaneous application for 8 weeks
干预措施: LEO 124249 ointment vehicle (Drug)
结局指标
主要结局
Subjects with treatment success according to Physician's Global Assessment (PGA) at visit 6 (End of Treatment)
时间窗: 56 days
Treatment success according to the PGA is defined as: Subjects having mild disease at baseline must achieve clear. Subjects having moderate or severe disease at baseline must achieve clear or almost clear
次要结局
- Hand Eczema Severity Index (HECSI) at visit 6(56 days)
- Subjects with treatment success according to the Patient's Global Assessment of disease severity (PaGA) at visit 6 (End of Treatment)(56 days)
研究者
研究点 (1)
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