CTRI/2023/03/050912尚未招募Unknown
Primary Objective: To evaluate the efficacy Skin Care Formulation in terms of Skin Brightening Effect on healthy female subjects. Secondary Objective: To evaluate the in-vivo safety and efficacy of a skin care formulation in terms of Improvement in Skin Water Barrier Function and in Skin Smoothness on healthy female subjects.
DPKA UNIVERSAL CONSUMER VENTURES PRIVATE LIMITED0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Indian / Asian female subjects
- •2.Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable
- •and stop the study, no pathology which could interfere with the study, no symptom in the process
- •of an exploratory checkup)
- •3.Between 18 and 50 years of age
- •4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ?¦.)
- •Specific criteria
- •5.44 Subjects representing varied skin types (ideally equal representation of all 4 skin types â?? Oily,
- •Normal, Dry and Combination)+13 sensitive skin (declared through lactic acid sting test).
- •6.Having wheatish to dark complexion.
排除标准
- •1.Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •2.Having refused to give her assent by signing the consent form
- •3.Taking part in another study liable to interfere with this study
- •4.Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area
- •5.Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less
- •than 6 months)
- •6.Having a progressive asthma (either under treatment or last fit in the last 2 years)
- •7.Being epileptic
- •8.Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6
- •9Having cutaneous hypersensitivity
- •10.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic
- •products or food products or to latex
- •11.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
- •(the only medication permitted is paracetamol)
- •12.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6
- •13.Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied
- •anatomic unit
- •14.Having applied a cosmetic product (included make-up) on the studied areas the first day of the
- •study (only face cleaned with water is accepted).
- •15.Do not take part in any family planning activities leading to pregnancy and breastfeeding
- •16.Do not take part in another study liable to interfere with this study
- •17.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)
- •18.Do not change her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit
- •19.During the study: Do not use other cosmetic products than the tested products to the studied areas (only usual cleanser/soap is accepted)
- •20.The day of the measurements: No test product must be used (only face cleaned with water is
- •21.Having started, changed or stopped a hormonal treatment (hormonal contraception, Hormone
- •Replacement Therapy) in the past 3 months.
- •22.Having started, changed or stopped her tobacco consumption (for smokers consuming more than
- •10 cigarettes per day) in the previous 6 months
- •23.Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn,
- •amiodarone, metals, minocyclineâ?¦) in the previous 6 months
- •24.Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta￾
- •caroteneâ?¦)
- •25.Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask â?¦) or having applied
- •self-tanning products in the week preceding the start of the study
- •26.Having applied products with anti-wrinkle action (Retinoic acid, retinol, retinaldehyde,
- •isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study
- •27.Having applied products with a depigmenting action (hydroquinone or derivatesâ?¦) in the 4 weeks
- •preceding the start of the study.
研究者
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