NCT02052531已完成2 期
A Phase II, Single Center, Double-blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of PAC-14028 Cream in Dermal Pruritus
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
- 试验地点
- 1
- 主要终点
- Change in Visual Analog Scale (VAS)
研究概览
简要总结
The objective of this study was to find a clinically appropriate dose of PAC-14028 cream by comparatively evaluating the efficacy and safety of PAC-14028 cream of Amorepacific Corporation in patients with dermal pruritus.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients at the age of 20 to 65 years old (both inclusive)
- •Pruritus test ≥ 5cm (10cm Visual Analogue Scale [VAS]) at baseline
- •Eczema or dry skin on the study drug application site
- •Women of childbearing potential should have a negative urine pregnancy test at screening and agree to employ an effective method of birth control (surgical sterilization or oral contraceptives, barrier method with spermicides, intrauterine device, etc.) during the study period.
- •Voluntarily signed written informed consent forms for study participation.
排除标准
- •Pruritus due to other medical (liver disease, renal failure, etc.), psychotic, or neuropathic causes rather than as a skin disease.
- •Chronic skin diseases such as malignant tumor or chronic urticaria, among skin diseases.
- •Simple pruritus caused by allergic substances such as scabies or insect bites.
- •Presence of symptoms of generalized infection at the time of study participation.
- •Previous local treatment or antibiotics administration for pruritus within 7 days prior to study participation.
- •Previous use of oral steroids within 1 month and local steroids within 2 weeks prior to study participation.
- •History of physical treatment for pruritus, including phototherapy, within 1 month prior to study participation.
- •Patients who are treated with prohibited concomitant drugs or considered to inevitably require treatment with prohibited concomitant drugs during the study period.
- •Renal function impairment with creatinine level
- •Hepatic function impairment with aspartate aminotransferase (AST)/ alanine aminotransferase (ALT)
- •Pregnant and lactating women
- •Participation in another clinical study within 1 month prior to screening.
- •Patients considered ineligible for study participation by the principal investigator or sub-investigator for other reasons; pruritus due to other medical (liver disease, renal failure, etc.), psychotic, or neuropathic causes rather than as a skin disease.
研究组 & 干预措施
PAC-14028 cream 0.3%
Experimental
PAC-14028 cream 0.3%, twice daily for 28 days
干预措施: PAC-14028 (Drug)
PAC-14028 cream 1.0%
Experimental
PAC-14028 cream 1.0%, twice daily for 28days
干预措施: PAC-14028 (Drug)
Vehicle
Placebo Comparator
Vehicle, twice daily for 28days
干预措施: Vehicle (Other)
结局指标
主要结局
Change in Visual Analog Scale (VAS)
时间窗: Baseline through Study Day 28
Patient reported outcome of pruritis measurement on a change in visual analog scale
次要结局
- Change in specified symptom sum score (SRRC) Index(Baseline through Study Day 28)
- Treatment success rate(Baseline through Study Day 28)
- Change in transepidermal water loss(Baseline through Study Day 28)
- Change in skin hydration(Baseline through Study Day 28)
研究者
研究点 (1)
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