CTRI/2013/12/004191已完成不适用
Cumulative Irritancy Study (12 Days)
Johnson Johnson1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年10月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Determination of Cumulative irritation potential of the test product by predictive patch test technique
研究概览
简要总结
Study Synopsis:-
-The objective of this study is to determine the cumulative irritation potential of the test materials by patch test.
-This is a controlled, single center study. Each test material will be applied every day for the 12 days (12 applications).
-patches will be applied for approximately a 24 hour period & then graded.
-25 normal healthy subjects will be enrolled in the study. Additional 5 subjects will be recruited to compensate for dropouts and incidence of irritation to patch material if any.
-The duration of the study is approximately 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects 18 to 65 years of age of Indian Race.
- •Subjects must be generally in good health as determined from a recent medical history which is on file with the investigator.
- •The ability of the subject to understand and sign a written informed consent form which must be obtained prior to treatment.
- •Willingness to avoid the use of topical products at the test sites during the study.
- •Willingness to avoid direct sun exposure to the test sites and the use of tanning beds for the duration of the study.
排除标准
- •Individuals with active or history of psoriasis, active allergic skin responses, or active eczema as determined by the initial paperwork.
- •Individuals with a history of eczema will be allowed on the study, as long as they complete a supplemental consent.
- •Individuals with sunburn, acne, abrasions, scar tissue, or tattoos on the test sites, or diseases of the skin that might interfere with the evaluation made in this study or that expose study participants to unacceptable risks.
- •Women known to be pregnant, nursing, or planning to become pregnant within the next six (6) months as determined by the initial paperwork.
- •Use of topical steroids and/or drugs at test sites as determined by the initial paperwork.
- •Current routine or frequent use of high doses of anti-inflammatory drugs for a defined medical condition as determined by the initial paperwork.
- •Aspirin use should not exceed two tablets (650 mg) daily.
- •Individuals who have had less than a two week rest period since completion of any previous patch testing.
- •Individuals currently receiving any anticancer, immunosuppressive treatments/medications, and/or radiation as determined by the initial paperwork.
- •Active or untreated skin cancer as determined by the initial paperwork.
- •Individuals with active hepatitis.
- •Previous clinically determined allergic reaction on a patch study, or known sensitivities or allergies to personal care products of any type.
- •Individuals will be admitted to the study at the discretion of the Investigator based on medical history and findings of the pre-study interview and examination.
结局指标
主要结局
Determination of Cumulative irritation potential of the test product by predictive patch test technique
时间窗: 12 days evaluation continuously
次要结局
未报告次要终点
研究者
研究点 (1)
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