CTRI/2025/06/088326尚未招募不适用
To evaluate the in vivo safety and efficacy of skin care formulation in terms of skin brightening on healthy human subjects
PT Invent India Pvt. Ltd.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年6月14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
- 36
- 试验地点
- 1
- 主要终点
- Skin brightening
研究概览
简要总结
OBJECTIVE - The objective of this study is to evaluate the in-vivo safety and efficacy of skin care formulation in terms of skin brightening on healthy human subjects The evaluation is performed using- Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Chromametry The study lasts 1 days following the first application of the product on whole face. POPULATION-36 females subjects will be selected for the study. The subjects selected for this study will be healthy females, aged between 18 and 45 years, having wheatish to dark complexion. STUDY DURATION- 1 days following the first application of the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Indian Females subjects 2.Healthy subjects 3.Skin is healthy on the studied anatomic unit 4.Having wheatish to dark complexion.
排除标准
- •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 and Informed consent form
- •Taking part in another study liable to interfere with this study
- •Being known diabetic case
- •Known asthma case
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •Being known thyroid case
- •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 or corticosteroid by any route (the only medication permitted is paracetamol)
- •Known case of hypersensitivity.
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
结局指标
主要结局
Skin brightening
时间窗: Baseline, 30 minutes 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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