NCT05896215进行中（未招募）2 期
A Phase II Clinical Study of KNP2002 Ointment in Patients With Common Warts (OM202JA)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 159
- 试验地点
- 15
- 主要终点
- Change in wart area
研究概览
简要总结
The goal of this clinical trial is to evaluate safety and efficacy of KNP2002 in patients with common warts aged 15 to 50 years old.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 15 to 49 years old
- •Subjects with common warts on the upper or lower limb
- •Subjects who agree to contraception from obtaining consent to 4 weeks after the end of administration
- •Subjects who have given their voluntary written consent to participate in this clinical trial
排除标准
- •Subjects with 5 or more warts on the upper or lower limbs
- •Subjects who are scheduled to undergo treatment such as physical therapy or chemotherapy for warts
- •Subjects with a history of allergy to topical skin preparations
- •Subjects with a history of malignant tumor within 5 years before administration of study drug
- •Subjects with any of the following diseases: Malignant tumor; Serious heart disease; Poorly controlled diabetes/hypertension
- •Women who are pregnant, may become pregnant, or are breastfeeding
研究组 & 干预措施
Low dose group
Experimental
Topical administration of low dose of KPN2002
干预措施: KNP2002 (Drug)
Middle dose group
Experimental
Topical administration of middle dose of KPN2002
干预措施: KNP2002 (Drug)
High dose group
Experimental
Topical administration of high dose of KPN2002
干预措施: KNP2002 (Drug)
Placebo group
Placebo Comparator
Topical administration of placebo
干预措施: Placebo of KNP2002 (Drug)
结局指标
主要结局
Change in wart area
时间窗: At 16 weeks after starting administration
Percent change in wart area from baseline
次要结局
- Wart improvement rate(At 4, 8, 12, and 16 weeks after starting administration)
- Change in wart area over time(At 4, 8, 12, and 16 weeks after starting administration)
- Wart disappearance rate(Up to 16 weeks after starting administration)
研究者
研究点 (15)
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