CTRI/2026/01/101439尚未招募不适用
To evaluate safety and efficacy of skin care formulations in terms of non comedogenic effect on healthy human female subjects.
Amvigor Organics Pvt Ltd1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2026年1月27日
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
研究概览
简要总结
| OBJECTIVE:The objective of this study will be to evaluate the safety and efficacy of skin care formulations in terms of non-comedogenic effect on healthy human female subjects The evaluation is performed using: Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy |
POPULATION:72 female subjects will be selected for this study.The subjects selected for this study will be healthy females aged between 18 to 35 years, having oily to mixed oily skin type
STUDY DURATION: 28 days following the application of the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Indian female subjects.
- •2.Healthy subjects 3.Skin is healthy on the studied anatomic unit 4.Having mixed oily or oily skin on the face (visual assessment by dermatologist).
排除标准
- •1 Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2 Having refused to give her assent by not signing the consent form 3 Taking part in another study liable to interfere with this study 4 Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months) 5 Having a progressive asthma (either under treatment or last fit in the last 2 years) 6 Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 7 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8 Being epileptic.
- •9 Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 10 Having cutaneous hypersensitivity.
- •11 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •12 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.
研究点 (1)
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