A Phase 1, Randomized, Evaluator Blinded, Controlled Study to Evaluate the Sensitizing Potential of M518101 in Healthy Volunteers Using a Repeat Insult Patch Test Design
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- inflammatory skin response score
研究概览
简要总结
This is a single center, randomized, controlled, within subject comparison, multiple dose study to determine the sensitization potential of M518101 on normal skin under occlusive patch condition.
详细描述
During the Induction Phase of the study, the study drugs and controls will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.
Following induction, subjects will have a 10 to 14-day Rest phase, after which they will enter the challenge Phase, which consists of one 48-hour patch application (occlusive) to a naïve site on the opposite side of the back.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Health male or female subjects are age 18 years or older
- •Signed and dated Informed Consent Form obtained prior to any study related activities
- •Subjects are free of any systemic or dermatologic disorder
- •For female, females of non childbearing potential or who agree to use a highly effective method of birth control during the study and have a negative urine pregnancy test
- •Subjects must be able to communicate with the investigator and understand and comply with the requirement of the study and visit schedule
排除标准
- •Have any visible skin disease at the application site which will interfere with the evaluation of the test site reaction
- •Have damaged skin in or around the test sites
- •Have a history of sensitivity to adhesive tape
- •Have a known sensitivity to constituents present in the material being evaluated
- •Have a history of, or are currently being treated for skin cancer
- •Have used any study drug and/or participate in any clinical study within 60 days prior to randomization
- •To engage in any type of strenuous exercise
- •Are pregnant, breastfeeding, or of childbearing potential and who wish to become pregnant during the study
- •Are deemed to be ineligible by the investigator
研究组 & 干预措施
M518101
M518101 will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.
干预措施: M518101 (Drug)
M518101 Vehicle
M518101 Vehicle will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.
干预措施: M518101 Vehicle (Drug)
Saline
The saline will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.
干预措施: Saline (Other)
Sodium lauryl sulfate
The sodium lauryl sulfate will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.
干预措施: Sodium lauryl sulfate (Other)
结局指标
主要结局
inflammatory skin response score
时间窗: 21 days
Drug application site will be evaluated for sign of inflammatory skin response (e.g. erythema, edema, papules)
次要结局
未报告次要终点