Evaluation of dermatological safety of test materials by sequential patch testing under complete occlusion in adults.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective
研究概览
简要总结
The study consist of 2 parts, Part A and Part B in part A subjects will be exposed to test product using sequential patch testing method at time points , 15 mins,30 mins,1 hour, 2hour, 3 hour,4 hour followed by will be evaluated and will be scored using Human irritation score (Reference ISO 10993-23:2021(E)) at timepoints at +Timm, +1hour, +2hour,+24 hours,+48 hours and + 72 hours. If the participants with a pilot batch exposed in part A completes the study with no AE or AR, then the study will proceed with Part B there the subjects will be exposed to to 4 hours and 24 hours respectively and will be evaluated at same time points as Part A.
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 (at least one third of either sex)
- •Subjects in good health condition as per the health 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 their willingness to participate.
- •Subjects willing to maintain the patch test in position for the required duration.
- •Subjects willing to come for regular follow-up visits.
- •Subjects with a broad upper back.
- •Subjects ready to follow instructions during the study period.
排除标准
- •Subjects with known history of clotting or bleeding disorder such as hemophilia(self- declared) .
- •Subjects with skin allergy, antecedents or atopic subjects.
- •Athletes and subjects with history of excessive sweating.
- •Subjects taking anticoagulant therapies or low dose aspirin(self-declared).
- •Subjects with known sensitivity to the test material or showing any signs of dermatitis.
- •Subjects prone to actinic keratoses and keloid scars.
- •Any systemic infection or disease that may affect the study as per PI ‘s discretion, such as diabetes or cancer.
- •Subjects with cutaneous disease or skin infection, or damage at the site of application which may influence the study result.
- •Subjects who are currently pregnant or lactating or planning to become pregnant in the period of study (self-declared).
- •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/participating from one family/household.
- •Subjects who are employees of MSCR or sponsor.
结局指标
主要结局
Objective
时间窗: 15 min,30 min,1hour,2 hour,3 hour,4 hour,24 hour.
The objective of the study is to determine the irritation potential of the test
时间窗: 15 min,30 min,1hour,2 hour,3 hour,4 hour,24 hour.
materials by a sequential patch test.
时间窗: 15 min,30 min,1hour,2 hour,3 hour,4 hour,24 hour.
次要结局
- NA(NA)
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd