Skin Irritation and Phototoxicity Study of KX01 Ointment 1% in Japanese Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Phototoxic potential at application site
研究概览
简要总结
Skin Irritation and Phototoxicity Study of KX01 Ointment 1% in Japanese healthy male subjects
详细描述
A baseline evaluation of the patch sites will be performed immediately prior to application of the patches to ensure that no conditions, markings, or coloration of the skin will interfere with interpretation of the study results.
A total of 4 application sites (2 cm x 2 cm each) will be marked on each subject's back, placing 2 sites for KX01KX2-391 ointment 1% and 2 sites for Placebo vehicle ointment. One set (KX01 ointment 1% IP and Placebo ointment vehicle patches) will be designated for irradiation and the other set will remain non-irradiated under open conditions. The distance between the patches will be no less than one centimeter.
The numbering of the test sites will remain the same throughout the study. The sites will be marked with an indelible, surgical marker.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Masking: 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
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese male adult, whose age 20-65 years old
排除标准
- •History of photosensitivity or photoallergy
研究组 & 干预措施
KX01 ointment and Placebo ointment
干预措施: KX01 ointment 1% (Drug)
KX01 ointment and Placebo ointment
干预措施: Placebo ointment (Drug)
结局指标
主要结局
Phototoxic potential at application site
时间窗: 9 days
Phototoxic potential will be evaluated according to the criteria (response scores and response notations). The same evaluator, if possible, should perform the assessment throughout the study.
Degree of skin irritation at application site
时间窗: 9 days
Degree of skin irritation will be evaluated according to the criteria (response scores and response notations). The same evaluator, if possible, should perform the assessment throughout the study.
次要结局
- Number of participants with adverse events as a measure of safety(9 days)