NCT02748993已完成1 期
A Randomized, Double-blind, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Systemic Exposure and Efficacy of PAC-14028 in Children With Mild to Moderate Pediatric Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 3
- 主要终点
- Success rate of Investigator's Global Assessment (IGA)
研究概览
简要总结
This is a phase 1 and 2 study to assess the safety and efficacy of PAC-14028 cream in children with atopic dermatitis.
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
- 24 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 24 months - 12 years
- •Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria, whose affected BSA is over 5% and IGA score is 2 (mild) to 3 (moderate).
- •Who has applied stable amount of emollients daily before baseline visit
- •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, psychial disorder that can affect study results.
- •Who has used systemic steroids, antibiotics, immunosuppressants, or received photochemical therapy within 28 days before study drug administration.
- •Who has used topical steroids, immunosuppressants 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 0.1%
Experimental
PAC-14028 Cream 0.1%, Twice daily for 4 weeks
干预措施: PAC-14028 Cream 0.1% (Drug)
PAC-14028 Cream 0.3%
Experimental
PAC-14028 Cream 0.3%, Twice daily for 4 weeks
干预措施: PAC-14028 Cream 0.3% (Drug)
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)
结局指标
主要结局
Success rate of Investigator's Global Assessment (IGA)
时间窗: 4 weeks
% of patients with IGA score of 0 (clear) or 1 (almost clear)
Blood concentrations of PAC-14028
时间窗: Day 1, Day 28
Blood concentrations of PAC-14028
次要结局
- Change of IGA (Investigator's Global Assessment)(1, 2, 4 week(s))
- Change of SCORAD (Severity Scoring of Atopic Dermatitis)(1, 2, 4 week(s))
- % Change of EASI (Eczema Area and Severity Index)(1, 2, 4 week(s))
- Patient satisfaction measurement(4 weeks)
研究者
研究点 (3)
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