Evaluation of dermatological safety of investigational products by 24hrs patch test under semi, open and complete occlusion on healthy Indian human participants 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 varied skin types in a Primary Irritation Patch Test.
研究概览
简要总结
This study is conducted in accordance with Bureau of Indian Standards (BIS) 13424:2001 and 4011:2018 for the Safety Evaluation of Cosmetic Samples in human participants. The objective is to evaluate the skin irritation potential of a cosmetic test sample following a single 24-hour occlusive patch application on the upper back of healthy adult volunteers. Participants will be screened to ensure the absence of any dermatological or physical conditions that may interfere with test results. Written informed consent will be obtained from all participants prior to enrollment.
The test sample will be applied on a defined skin site between the scapula and waist (upper back) under an occlusive patch for 24 hours. After patch removal, skin reactions such as erythema, oedema, or papules will be evaluated subjectively using the Draize Scale. A follow-up assessment will be performed one week later to confirm recovery. The total study duration per participant will be approximately 9 days.
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
- •Participants in age group
- •65 years (both the ages inclusive).
- •Healthy male & female participants with skin types as defined in the population details under appendix.
- •Participants with Fitzpatrick skin type III to V
- •Participants 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.
- •Participant able to read, understand and sign an appropriate informed consent form indicating her willingness to participate.
- •Participants willing to give a voluntary written informed consent.
- •Participants willing to maintain the patch test in position for 24 hours.
- •Participant having not participated in a similar investigation in the past two weeks.
- •Participants willing to come for regular follow up visits.
- •Participants ready to follow instructions during the study period.
排除标准
- •Participants with infection, allergy on the tested area.
- •Participants with skin allergy, antecedents or atopic participants.
- •Athletes and participants with history of excessive sweating.
- •Participants with cutaneous disease which may influence the study result.
- •Participants on oral corticosteroid.
- •Participants participating in any other cosmetic or therapeutic trial.
- •Participants who are currently pregnant or lactating or planning to become pregnant in the period of study.
- •Participants 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 Participant selected/ participating from one family/ household.
- •Participants 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 varied skin types in a Primary Irritation Patch Test.
时间窗: Baseline, 0-hour, 24-hour and Day7
次要结局
未报告次要终点
研究者
Dr Chandan B C
MS Clinical Research Pvt. Ltd