Evaluation of skin hydration, after application, of 1 test product (Venusia CeraPlus Lotion) on volar forearms, after 12 hours and 24 hours in men and /or women.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1. Hydration evaluation
研究概览
简要总结
There will be 1 test product ‘Venusia CeraPlus Lotion, involved in the study. This is a
cosmetic product.
Moisturizers are widely used in various dermatologic and cosmetic skin therapies. Different
classes of moisturizers are based on their mechanism of action, including occlusives,
humectants, emollients, and protein rejuvenators. Commercially available moisturizers often
utilize components of each of these classes to provide their beneficial effect. Scientifically, the
moisturizing treatment involves a 4-step process:
 Reducing TEWL
 Repairing the skin barrier
 Increasing water content
 Restoring the lipid barriers’ ability to attract, hold and redistribute water.
Occlusive agents increase moisture levels by providing a physical barrier to epidermal water
loss. Ingredients with occlusive properties include petrolatum, waxes, oils, and silicones.
Humectants work by attracting water from the dermis below and helping to keep that water
bound in the stratum corneum. Humectants include ingredients like glycerin, urea, and
pyrrolidone carboxylic acid (PCA).
Emollients smooth skin by filling spaces between skin flakes with droplets of oil and are not
usually occlusive unless applied heavily. When combined with an emulsifier, they may help hold
oil and water in the stratum corneum. Examples of emollients include mineral oil, lanolin, fatty
acids, cholesterol, squalene, and structural lipids
.
Results: The study was completed with 32 complete cases and no adverse events were reported during the study.
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 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Voluntary men and /or women between 18 and 55 years of age.
- •Dry skin type (MoistureMeter SC Readings less than 20).
- •Having signed a Consent Form after the study has been explained orally and in writing, of all information concerning the study procedures and study objectives.
- •Presenting healthy skin on test sites.
- •Cooperating informed of the need and duration of the examinations.
排除标准
- •Menopausal/Pregnant women by UPT, Lactating mothers.
- •Allergic to any cosmetic product.
- •A participant who the Investigator feels will not be compliant with study requirements.
- •Any type of skin disorder which Investigator feels will interfere with the study
- •Participants on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
- •E.g. topical steroids.
- •Chronic illness which may influence the skin sensitivity (skin problems like atopic dermatitis, psoriasis, eczema or diseases like hypothyroidism, anaemia, hormonal problems, or patients on anti-cholesterol drugs, etc)
- •Any cutaneous disease which would predispose to dry skin (confirmed by prior history).
- •Any cutaneous conditions on test site (scars, moles, papules etc).
- •Subject in an exclusion period or already participating in another similar cosmetic or therapeutic trial as identified during screening on visit 1 (V1).
结局指标
主要结局
1. Hydration evaluation
时间窗: 0 hour, 12 hour, 24 hour
2. Trans-epidermal water loss evaluation
时间窗: 0 hour, 12 hour, 24 hour
次要结局
未报告次要终点
研究者
Dr Rajiv Joshi
Clinical Aesthetics and Investigative Management Services Pvt. Ltd.