CTRI/2022/03/041526已完成不适用
Evaluation of dermatological safety of investigational products by cumulative irritancy test for 14 days under complete occlusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate the dermatological safety of the investigational products on healthy human subjects
研究概览
简要总结
Study will be conducted to assess the safety of the test products. After consenting and qualifying the inclusion and exclusion criteria subjects will be enrolled into the study. For the selected subjects, the patch will be applied eveyday for 14 days. The assessment will be perfoemed for every 24 hrs once the patch is applied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- 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 normal, dry, oily, combination and sensitive skin type in equal ratio.
- •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 22-24 hours as instructed.
- •Subjects willing not to apply any topical product at the test site for the entire study durations.
- •Subjects willing to refrain the test sites from direct sun light
- •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
- •Infection, allergy on the tested area.
- •Skin allergy, antecedents or atopic subjects.
- •Athletes and subjects with history of excessive sweating.
- •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.
- •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 working with either MSCR or the sponsor.
结局指标
主要结局
To evaluate the dermatological safety of the investigational products on healthy human subjects
时间窗: Approximately 14 days for each subject
次要结局
未报告次要终点
研究者
研究点 (1)
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