NCT02583022已完成2 期
A Randomized, Open-label, Single Center, Investigator-initiated Clinical Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Subjects With Mild to Moderate Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 主要终点
- SCORing Atopic Dermatitis (SCORAD) index
研究概览
简要总结
The study is a Phase II, single center, randomized, open-label, placebo-controlled study in male and female subjects, aged ≥ 20 years with mild to moderate atopic dermatitis. All subjects will receive BID topical applications of PAC-14028 cream or vehicle or Elidel cream for up to 4 weeks.
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
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged between 20 and 65 years old
- •Patients with atopic dermatitis, diagnosed according to Hanifin and Rajka diagnostic criteria
- •SCORAD (SCORing Atopic Dermatitis) Score less than 40
排除标准
- •Patients presenting symptoms of systemic infection at screening
- •Patients who had been treated with oral steroids, oral antibiotics, systemic phototherapy, or immunosuppressants within the last 1 month prior to the investigational product administration
- •Patients who had been treated with topical steroids or antibiotics within the last 2 weeks prior to the investigational product administration
- •Pregnant women or breastfeeding women
- •Women of childbearing potential or women who are planning a pregnancy during the study
研究组 & 干预措施
PAC-14028 cream 1.0%
Experimental
PAC-14028 cream 1.0%, Twice daily for 4 weeks
干预措施: PAC-14028 cream 1.0% (Drug)
PAC-14028 cream vehicle
Placebo Comparator
PAC-14028 cream vehicle, Twice daily for 4 weeks
干预措施: PAC-14028 cream vehicle (Drug)
Elidel cream 1%
Active Comparator
Elidel cream 1%, Twice daily for 4 weeks
干预措施: Elidel cream 1% (Drug)
结局指标
主要结局
SCORing Atopic Dermatitis (SCORAD) index
时间窗: Change from baseline at Day 28
次要结局
- Each SCORAD index(Change from baseline at Day 7, 14 and 28)
- Visual Analogue Scale (VAS) score(Change from baseline at Day 7, 14 and 28)
- Success rate to pruritus treatment(Change from baseline at Day 7, 14 and 28)
- Eczema Area and Severity Index (EASI) score(Change from baseline at Day 7, 14 and 28)
- Transepidermal Water Loss (TEWL) level(Change from baseline at Day 7, 14 and 28)
- Skin Hydration level(Change from baseline at Day 7, 14 and 28)
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