21-day Cumulative Irritation Test
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Severe irritation (Grade 3 or 4) observed at any site
研究概览
简要总结
The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.
详细描述
Healthy, adult volunteers of either sex will be patched on his/her back with AN2690 Solution 2.5%, AN2690 Solution 5%, AN2690 Solution 7.5%, AN2690 Solution Vehicle and Sodium Laurel Sulfate 0.5% over the course of 21 consecutive days. After 24 hours, the patches are to be removed and the site evaluated using a five-point scale for irritation.
研究设计
- 研究类型
- Interventional
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, volunteers of either sex, at least 18 years of age or older
- •Females of childbearing potential submitted to a urine pregnancy test and had negative results at Day 1 and at the final visit and also was using an effective method of birth control (e.g. abstinence, implants, injectables, oral contraceptives, intrauterine contraceptive devices or double barrier) or agreed to use an effective method of birth control prior to becoming sexual active
- •Subjects were of any skin type or race providing their degree of pigmentation did not interfere with making readings of skin reactions
- •Subjects were willing to follow the study procedures and complete the study
- •Written informed consent was obtained
排除标准
- •Subject with any skin disease that would have in any way confounded interpretation of the study results. Atopic dermatitis/eczema, psoriasis or chronic asthma were excluded
- •Subject was pregnant or nursing
- •Subject had a history of sensitivity to any component of any of the formulations
- •Use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before and during the study
研究组 & 干预措施
A
AN2690 Solution, 2.5%
干预措施: AN2690 (Drug)
B
AN2690 Solution, 7.5%
干预措施: AN2690 (Drug)
C
AN2690 Solution, 5.0%
干预措施: AN2690 (Drug)
D
AN2690 Solution, Vehicle
干预措施: AN2690 Solution, Vehicle (Other)
E
Sodium Lauryl Sulfate, 0.5%
干预措施: Sodium Lauryl Sulfate, 0.5% (Other)
结局指标
主要结局
Severe irritation (Grade 3 or 4) observed at any site
时间窗: Daily for 21 days
次要结局
未报告次要终点