CTRI/2025/01/079508尚未招募不适用
T o evaluate and compare the in vivo efficacy (12 hr. moisturization time claim) and safety of Skin Care Formulation verses Untreated Control in terms of skin moisturization on healthy female subjects
Panacea Biotec Pharma 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2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
- skin
研究概览
简要总结
OBJECTIVE
The objective of this study will be to evaluate and compare the in vivo efficacy and safety of Skin Care Formulation verses Untreated Control in terms of skin moisturization on healthy female subjects for product.
Test Product: Baby Massage Oil: Product A
Baby Lotion: Product B
Techniques: The evaluation is performed using: 1) Subject Self Evaluation, 2) Dermatological Evaluation: Safety and 3) Corneometry
Total duration of the study: 12 hours following the first application of the product.
Kinetics: T0, T+30 Minutes after product application, T+6 Hours after product application, T+8 Hours after product application & T+12 Hours after product application
POPULATION: 33 female subjects will be selected for the study.
The subjects selected for this study are healthy female subject, aged between 18 and 40 years old, having dry skin on forearms
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
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 female subjects 2)Healthy subjects 3) Skin is healthy on the studied anatomic unit 4) Subject having dry skin on forearms.
排除标准
- •Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
- •Having refused to give 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.
- •Having changed their cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit.
- •Having applied a cosmetic product (included make-up) on the studied areas 48 hours prior study. Refusing to follow the restrictions below during the study:
- •Do not take part in any family planning activities leading to pregnancy and breastfeeding. Do not take part in another study liable to interfere with this study.
- •Do not take 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)
- •Do not change her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit
- •During the study: Do not use other cosmetic products than the tested products to the studied areas. Specific criteria
- •Having started, changed, or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy, thyroid…) in the past 3 months.
- •Having taken an oral retinoid-based treatment in the past 6 months
- •Having taken a local retinoid-based treatment on the studied areas in the previous month
- •Having had beauty treatment (e.g. scrub, manicure, self-tanning product …) in the previous week
- •Having practiced water activities (swimming pool, sauna, hammam, baleneotherapy etc.) in the previous week.
- •Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
- •Having practiced intensive sports during the day prior to the T0 measurements
- •Having wounds, Scars, sunburns, tattoos and piercing on test site.
- •Having hair on test site.
- •Having applied another product than water on the studied areas in the morning of the T0 measurements
- •Having had an intensive UV exposition on the inner forearm (solariums, sun) prior to T0 measurements.
- •Having used moisturizing products on the arms during 24 hours prior to T0 measurements. Refusing to follow the restrictions below during the study:.
- •Do not have beauty treatment (e.g. scrub, manicure self-tanning product …).
- •Do not practice water activities (swimming pool, sauna, hammam, balneotherapy etc.).
- •Do not drink/ eat caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food, nor smoke.
- •Do not practice sport.
- •Do not apply any product on inner forearm including water.
- •Do not wipe their forearm.
- •Do not wear jewels on the wrists.
- •Do not have an intensive UV exposition on the arms (solariums, sun). Between T0 and T+12 hours measurements:.
- •Do not use skin care products on the inner forearms.
- •Do not wash the inner forearms.
- •Do not use Surfactant containing product on the test sites.
结局指标
主要结局
skin
时间窗: T0, 30 Minutes | after product application, 6 Hours after product application, 8 Hours after product application | & 12 Hours after product application
moisturization
时间窗: T0, 30 Minutes | after product application, 6 Hours after product application, 8 Hours after product application | & 12 Hours after product application
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.
研究点 (1)
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