CTRI/2025/03/081742尚未招募不适用
To evaluate and compare the in vivo safety and efficacy of Skin Care Formulations verses Untreated Control in terms of skin barrier function on healthy female subjects
AU Naturel Beauty Pvt. Ltd (NEUDE)1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Skin barrier function
研究概览
简要总结
OBJECTIVE: The objective of this study will be to evaluateand compare the in-vivo safety and efficacy of Skin Care Formulation versesUntreated Control in terms of skin barrier function on healthy female subjectsfor products coded:
The evaluation is performed using: Subject Self Evaluation, DermatologicalEvaluation: Cosmetic Acceptability, Tewametry
POPULATION: 33 Female subjects will be selected for thestudy.
The subjects selected for this study are healthy females,aged between 18 and 40 years old, having dry skin type.
STUDY DURATION: 24 hours following the first application ofthe product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Indian subjects 2)Healthy subjects 3)Skin is healthy on the studied anatomic unit 4)Subject having dry skin type.
排除标准
- •Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •Having refused to give her/his assent by not signing the consent form
- •Taking part in another study liable to interfere with this study
- •Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
- •Having a progressive asthma (either under treatment or last fit in the last 2 years)
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •Being epileptic.
- •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.
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
结局指标
主要结局
Skin barrier function
时间窗: Baseline, 30 minutes after product application, 24 hours after product application
次要结局
未报告次要终点
研究者
研究点 (1)
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