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临床试验/CTRI/2021/05/033909
CTRI/2021/05/033909已完成不适用

A Single Center, Application Site Randomized, Evaluator-Blinded, Moisturization Study to Evaluate the moisturization properties of Test Products in Healthy Adult & Adolescent Human Subjects

Zydus Wellness Limited1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年3月6日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
1.To assess the effect of test product(s) on skin moisture i.e. hydration state of the skin change from baseline

研究概览

简要总结

The physiological mechanism ofskin moisturization consists of a stratum corneum (SC) containing 10–15% waterin order to remain flexible and elastic. The SC comprises predominantlyhydrophobic substances and is an essential factor that slows down corneocytedehydration and ensures enzymatic activity. Dry skin is characterized by amoisture content of less than 10%, which is coherent with a loss of continuityof the SC. Transepidermal water loss (TEWL) is the most widely used surrogatemarker for skin barrier function

Moisturizersenhance the water-holding capacity of the skin. They are commonly used by allage groups and in both genders regardless of the presence of a skin disease.Functional skin benefits are sought with application of these products onfacial skin by making the skin soft and smoother, increasing skin hydration andskin rejuvenation. Indeed, the application of moisturizers achieves anappearance benefit. However, recent studies suggest that long-term therapy withmoisturizers not only strengthens but also weakens the skin barrier functionand may influence its recovery subsequent to damage .

Adequate skin hydration iscritical for maintaining healthy skin, and moisturizers are an importantcomponent of basic skin care. The ability of the skin to hold water isprimarily related to the stratum corneum (SC), which plays the role of barrierto water loss. The importance of SC water content to “normal†nonflaky skinappearance has long been known, with healthy tissue containing >10% water

SC intercellular lipidsorderly arranged to form a barrier to transepidermal water loss (TEWL). Theintercellular lipid organization and consequently the SC barrier properties arealso linked to the existence of a lipid gradient as demonstrated in the dermis,hyaluronic acid (HA), a high molecular weight glycosaminoglycan with markedlyhydrophilic properties, contributes to the hydration and plastic properties ofthe skin

The skin’s primary function isto provide a protective barrier that maintains internal nourishing hydrationand electrolytes while preventing entry of exogenous substances such asbacteria, allergens, particulates, pollution, etc. The outermost layers of theskin, the stratum corneum (SC), are often described as a bricks(cells)-and-mortar (lipid) structure. Scientist and clinicians believe thatthis structure creates a tortuous path through the “mortar†that inhibits theflow of water from the skin and contaminants into the skin

The children’s skinis sensitive and prone to irritation and eczema. Skin care is importantespecially in infancy as the skin barrier matures during the first year oflife. Many children’s have some areas of dry skin. During the children usuallyneed extra care and moisturization for their skin. Some children’s have skinthat is very dry and splits, especially around the ankles and hands. Hence, youmay need touse cream to moisturize.

The adult’s skinis sensitive and prone to irritation and eczema. Skin care is important. Someadults have skin that is very dry and splits, especially around the ankles andhands. Hence, you may need touse cream to moisturize or soothe skin irritation. Adult’s moisturizersthat is mild and fragrance-free keeps newborn’s skin from becoming too dry. Ifyou want to use cream, choose one that does not have perfume or dyes, such asAquaporin or Eucerin

Theaim of this observational study is determined the effectof moisturizers properties of various moisturizers on all skin types in healthyadults and adolescent subjects. The proposed benefits are evaluated by thedermatologist/dermatologist trained evaluator and assessment questionnaire at24 hours, 48 hours after test product application. The instrumental evaluationof skin hydration will be done at before application to 4hours, 8 hours, and 24 hours and 48 hours after test product application

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
13.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Adults subjects between ages of 18 to 30 (both inclusive) years old and in the age range from 13 to 17 Years (inclusive of both genders) at the time of consent.
  • Subject general in good health as determined from a recent medical history.
  • Subject is willing to participate in the study, give a voluntary written informed consent OR an assent and consent of the respective Legal guardian in case of adolescent subjects.
  • Subjects willing to abide by and comply with the study protocol.
  • Subjects should not participate in any other clinical study during participation in the current study.

排除标准

  • Use of Body milk /lotion / cream, cosmetics or any other body moisturizing product before 3-5 days prior to study and during the study period.
  • Chronic illness which may influence the cutaneous state.
  • Subjects on any systemic medication.
  • Subject with history of diabetes 5)Subjects participating in a similar clinical study, currently or during the previous 30 days.
  • Any Subjects, in the Investigator opinion not considered suitable for enrollment.
  • A known history or present condition of allergic response to any other concern that may require medical attention.
  • Adults with medical history (past/present) of significant dermatological diseases or conditions, such as atopy, psoriasis, vitiligo or other conditions known to alter skin appearance or physiologic response (e.g. porphyria) chronic urticaria, or sunburn, rashes.

结局指标

主要结局

1.To assess the effect of test product(s) on skin moisture i.e. hydration state of the skin change from baseline

时间窗: 1.Day 1 before application to T4 hours T8 hours T24 hours and T48 hours | 2.Day 1 before application to T4 hours T8 hours T24 hours and T48 hours | 3.Day 1 before application to T4 hours T8 hours T24 hours and T48 hours

2.To assess the effect of test product(s) on skin barrier function

时间窗: 1.Day 1 before application to T4 hours T8 hours T24 hours and T48 hours | 2.Day 1 before application to T4 hours T8 hours T24 hours and T48 hours | 3.Day 1 before application to T4 hours T8 hours T24 hours and T48 hours

3.To assess the effect of test product(s) on skin physical parameter using 5-point scoring scale for skin dryness, skin roughness, skin suppleness and softness, skin redness/erythema, burning, itching and stinging from baseline

时间窗: 1.Day 1 before application to T4 hours T8 hours T24 hours and T48 hours | 2.Day 1 before application to T4 hours T8 hours T24 hours and T48 hours | 3.Day 1 before application to T4 hours T8 hours T24 hours and T48 hours

次要结局

  • 1 To assess Product response index (perception about product) after application(1 On Day 3)

研究者

申办方类型
Other [Health and Hygiene Industries]

研究点 (1)

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