To evaluate the in vivo safety and efficacy of cosmetic formulation in Conferring skin benefits in healthy human Indian subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ITC LIMITED
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Skin cleansing, Sebum and Acne Control, overall skin parameters
研究概览
简要总结
Brief Summary: The study aims at assessing the safety and skin benefitting efficacy of the investigational products over a 28 day use duration by healthy human Indian adults with periodic assessments pre and post use, 1 day post use, Post 1 week, 2 weeks, 3 weeks and 4 weeks of Use.
Assessments:(a) Non invasive Insturmental measurements for skin hydration, barrier, Sebum, imaging.
(b) Dermatologists Assessment of product safety, tolerance and skin benefitting efficacy and
(c) Subjects self assessment of product safety, tolerance and skin benefitting efficacy.
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
- 19.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with Acne prone skin and uneven skin tone.
- •Subjects with no cuts, abrasions, wounds, injuries, allergies, tattoos, scars, henna or any other developments / artefacts on face and forearms that can impact the measurements.
- •Subjects willing to abide by the study protocol, laid restrictions and consenting to visit the site for periodic assessments on the scheduled dates.
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
Skin cleansing, Sebum and Acne Control, overall skin parameters
时间窗: Pre use, Post 1 use, 1 day post use, Post 7 days, 14 days, 21days and 28 days of use
次要结局
未报告次要终点
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.