NCT02965118已完成3 期
Multi Center, Randomized, Double-blind, Placebo-controlled Parallel-group, Phase III Clinical Trial to Evaluate the Safety and Efficacy of PAC-14028 Cream in Mild to Moderate Atopic Dermatitis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Success rate of Investigator's Global Assessment (IGA)
研究概览
简要总结
This is a phase III study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.
详细描述
PAC-14028 cream 1.0% or placebo will be treated to Mild to Moderate Atopic Dermatitis patients twice daily for 8 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 12 - 70 years.
- •Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria.
- •Whose affected TBSA is over 5% and below 30%, and IGA score is 2 (mild) to 3 (moderate).
- •Who voluntarily agreed to participate in the study and signed an informed consent form.
排除标准
- •Who has skin diseases other than atopic dermatitis or scar in the affected area which can affect the study, determined by the study investigators.
- •Who has clinically significant medical history or diseases involving liver, kidney, neurological system, psychical disorder that can affect study results.
- •Who has used systemic steroids, antibiotics, immunosuppressants, or received phototherapy within 28 days before study drug administration.
- •Who has used topical steroids, topical calcineurin inhibitors or antibiotics to treat atopic dermatitis within 14 days before study drug administration.
- •Who has used or is expected to inevitably use prohibited concomitant medications during the study.
- •Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives.
- •Who has dosed other study medications within 30 days before screening.
- •Who is determined ineligible for study participation by investigators for any other reasons.
研究组 & 干预措施
PAC-14028 cream 1.0%
Experimental
PAC-14028 cream 1.0% will be applied to treatment area twice daily for 8 weeks.
干预措施: PAC-14028 cream 1.0% (Drug)
PAC-14028 cream Vehicle
Placebo Comparator
PAC-14028 cream Vehicle will be applied to treatment area twice daily for 8 weeks.
干预措施: PAC-14028 cream Vehicle (Drug)
结局指标
主要结局
Success rate of Investigator's Global Assessment (IGA)
时间窗: 8 weeks
Percent of patients with IGA score of 0 (clear) or 1 (almost clear)
次要结局
- Change of Investigator's Global Assessment (IGA) score(8 weeks)
- Success rate of ≥2-grade Investigator's Global Assessment (IGA)(8 weeks)
- Percent of change in Eczema Area and Severity Index (EASI)(8 weeks)
研究者
研究点 (1)
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