Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects of varied skin types.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The objective of the study is to determine the potential irritation of the test formulation in different skin types in a Primary Irritation Patch Test
研究概览
简要总结
It is a primary irritation patch test clinical study under dermatological control. A patch test under occlusion is carried out using the occlusive chambers prefixed to a micropore tape followed by an assessment. This patch will then be applied on the test site i.e., between your scapulae and waist on your upper back. The patch will be kept for 24 hours. After which the patch will be removed and the first observation will be made at 30 minutes of patch removal (0 hr. reading). The further observations will be at 24 hrs, and 1 week post patch removal. The dermatological assessment will be done at each visit. Study would be conducted over a period of 9 days and would include a total of 4-5 visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects in age group
- •65 years (both the ages inclusive).
- •Healthy male & female subjects with skin types as defined in the population details under appendix.
- •Subjects with Fitzpatrick skin type III to V
- •Subjects in good health condition as per the medical screening criteria with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data.
- •Subject able to read, understand and sign an appropriate informed consent form indicating her willingness to participate.
- •Subjects willing to give a voluntary written informed consent.
- •Subjects willing to maintain the patch test in position for 24 hours.
- •Subject having not participated in a similar investigation in the past two weeks.
- •Subjects willing to come for regular follow up visits.
- •Subjects ready to follow instructions during the study period.
排除标准
- •Subjects with infection, allergy on the tested area.
- •Subjects with skin allergy, antecedents or atopic subjects.
- •Athletes and subjects with history of excessive sweating.
- •Subjects with cutaneous disease which may influence the study result.
- •Subjects on oral corticosteroid.
- •Subjects participating in any other cosmetic or therapeutic trial.
- •Subjects who are currently pregnant or lactating or planning to become pregnant in the period of study.
- •Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
- •More than one subject selected or participating from one family or household.
- •Subjects working with MSCR.
结局指标
主要结局
The objective of the study is to determine the potential irritation of the test formulation in different skin types in a Primary Irritation Patch Test
时间窗: 0 hr, 24 hr, 7 days
次要结局
- NA(NA)
研究者
Dr Navya Annam
MS Clinical Research