Modified Human Repeat Insult Patch Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Evaluation of sensitization potential of the test products by standard HRIPT method.
研究概览
简要总结
Study Synopsis: Objective of the study is to evaluate the sensitization potential of the test products by modified Human Repeat Insult Patch Test (HRIPT) Method. Total no. of subjects-110 Total no. of Visits- 14 All the test products will be applied as 48 Hours closed Patch Test on the subjects as 9 repeated applications over the induction phase of 3 weeks. Evaluation for irritation will be done before application of succeeding patch. This will be followed by a rest phase of approximately 2 weeks. Challenge patch of the test products shall be applied at test site and naive site for 48hrs under occlusion , followed by evaluation of sensitization at 48 hrs and 96 hrs post patch application. The cumulative score of irritation in induction phase will be used to classify the irritation potential of the product.
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 for the duration of the study.
排除标准
- •Individuals with active or history of psoriasis, active allergic skin responses, or active eczema a 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.
- •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
Evaluation of sensitization potential of the test products by standard HRIPT method.
时间窗: 6 Weeks and 11 Evaluations for each subject.
次要结局
未报告次要终点