NCT02565134已完成2 期
Multi Center, Double-blind, Randomized, Placebo-controlled Parallel-group, Dose Finding Phase II Clinical Trial to Evaluate Antipruritic Effect and Safety of PAC-14028 Cream (0.1%, 0.3%, 1.0%) in Skin Pruritus Patients
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
- 296
- 试验地点
- 1
- 主要终点
- Change in intensity of pruritus as measured by 10 cm VAS
研究概览
简要总结
The study is a Phase II, multi center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with skin pruritus. All subjects will receive BID topical applications of PAC-14028 cream or vehicle 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 19 - 70 years
- •Patients who have eczema or xerosis cutis at the area where investigational product is applied (arm or leg)
- •Patients whose result of the pruritus test (Visual Analogue Scale, VAS) at Visit 1 and 2 is 5 or more
- •Patients whose overall dry skin score of the area where investigational product is applied at Visit 1 and 2 is 2 points or more
排除标准
- •Patients with pruritus caused by other medical, psychotic and nervous causes other than the skin disease
- •Patients with such skin diseases as malignant tumor or chronic urticaria among patients with skin diseases
- •Patients with simple pruritus caused by such allergic material as scabies, and insect bite wound
- •Patients with the symptom of systemic infection at the time of the participation in the clinical study
- •Patients with a history of taking topical treatment drug, topical steroid agent or antibiotics for the treatment of pruritus within 2 weeks
- •Patients with a history of taking oral steroid agent within 4 weeks
- •Patients with a history of taking a physical treatment for the treatment of pruritus including phototherapy within 4 weeks
- •Pregnant or breast-feeding women
- •Women at a childbearing age who has childbearing potential or has a plan to get pregnant during the clinical study period
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
Change in intensity of pruritus as measured by 10 cm VAS
时间窗: Week 4 from baseline
次要结局
- Treatment success rate (A decrease in VAS by 2 or more is judged as a success)(Week 4 from baseline)
- Change in Overall Dry Skin (ODS) score(Week 4 from baseline)
- Change in Transepidermal Water Loss (TEWL)(Week 4 from baseline)
研究者
研究点 (1)
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