CTRI/2025/05/087604尚未招募不适用
Evaluation of the irritation potential of Skin Care formulations on healthy human subjects
Gandhar Oil Refinery India Pvt Ltd1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年3月6日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Dermatological safety / Irritation potential on skin
研究概览
简要总结
| Objective: The objective of this study will be to evaluatethe irritation potential on healthy human subjects of Skin Care Formulations |
Kinetics: T0 (Evaluation of test sites by Dermatologist, Patch application) ,T1(Patch removal, Evaluation of test sites by Dermatologist ,T2(Evaluation of test sites by Dermatologist and Subject post 24 hrs of patch removal), T8 (Evaluation of
test sites by Dermat and Subject post 1 week of patch removal and tracking the positive cases)
Population: 26 healthy subjects (13 males + 13 females) .
The test area is checked for erythema and oedema caused due to the products and compared with positive control
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant 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
- •Healthy Human Subjects 2) Skin should be healthy on the studied anatomic unit.
排除标准
- •For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
- •Having refused to give his/her assent by not signing the consent form.
- •Taking part in another study liable to interfere with this study.
- •Being diabetic.
- •Being asthmatic.
- •Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
- •Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
- •Having undergone a surgery requiring a general anesthesia of more than one hour in the past 6 months.
- •Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
结局指标
主要结局
Dermatological safety / Irritation potential on skin
时间窗: Baseline,0 hrs,24 hrs and 7 days
次要结局
未报告次要终点
研究者
研究点 (1)
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