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
- 44
- 试验地点
- 1
- 主要终点
- Irritation Score (5-point scale)
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 daily on his/her back with multiple strengths of AN2718 in 2 different topical dosage forms and an active comparator over the course of 21 consecutive days. Twenty-four hours after each application, the patches will be removed and the site evaluated using a five-point scale for irritation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Subjects must meet all of the following criteria for inclusion in the study.
- •Healthy volunteers of either sex, at least 18 years of age or older.
- •Females must be of non-childbearing potential (i.e., post-menopausal or surgically sterile [bilateral oophorectomy and/or total hysterectomy]). All females must submit to a urine pregnancy test and have a negative result at Day 1 and at the final study visit.
- •Subjects may be of any skin type or race providing their degree of skin pigmentation does not interfere with making readings of skin reactions.
- •Willingness to follow the study procedures and complete the study.
- •Written informed consent obtained.
排除标准
- •Any skin disease that would in any way confound interpretation of the study results. Atopic dermatitis/eczema, psoriasis will be excluded.
- •Chronic asthma will be excluded.
- •Pregnant or nursing mothers.
- •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
AN2718 Cream SF Vehicle
干预措施: AN2718 (Drug)
B
AN2718 Cream SF, 0.3%
干预措施: AN2718 (Drug)
C
AN2718 Cream SF, 1%
干预措施: AN2718 (Drug)
D
AN2718 Gel Vehicle
干预措施: AN2718 (Drug)
E
AN2718 Gel, 1.5%
干预措施: AN2718 (Drug)
F
AN2718 Gel, 2.5%
干预措施: AN2718 (Drug)
G
AN2718 Gel, 5%
干预措施: AN2718 (Drug)
H
AN2718 Gel, 7.5%
干预措施: AN2718 (Drug)
I
Sodium Lauryl Sulfate, 0.5%
干预措施: Sodium Lauryl Sulfate (Other)
结局指标
主要结局
Irritation Score (5-point scale)
时间窗: Daily for 21 days
次要结局
未报告次要终点