CTRI/2025/09/095325尚未招募不适用
To evaluate the in vivo safety of skin care formulation on perimenopausal and menopausal female subjects.
Sirona Hygiene Pvt. Ltd.1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2025年10月4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
- 33
- 试验地点
- 1
- 主要终点
- The product is safe for the skin by assessing possible reactions such as erythema, oedema, dryness, scaling, peeling, itching, and tingling.
研究概览
简要总结
OBJECTIVE : The objective of this study is to evaluate the in-vivo safety of skin care formulation on perimenopausal and menopausal females.The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability
POPULATION : 33 female subjects will be selected for the study. The subjects selected for this study will be healthy females, aged between 44 and 55 years; having perimenopausal and menopausal females.STUDY DURATION : 7 days following the first application of the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female Asian Indian subjects 2)Healthy subjects 3)Skin is healthy on the studied anatomic unit 4)Perimenopausal and menopausal females.
排除标准
- •For Females: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
The product is safe for the skin by assessing possible reactions such as erythema, oedema, dryness, scaling, peeling, itching, and tingling.
时间窗: Baseline, day 3, day 7
次要结局
未报告次要终点
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.
研究点 (1)
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