CTRI/2022/08/044838尚未招募未知
PRIMARY OBJECTIVE To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of in terms of skin brightening on healthy female subjects.SECONDARY OBJECTIVE To evaluate the in-vivo efficacy of a skin care formulation in terms of improvement in skin hydrationand improvement 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
- 未知
- 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
- •1Indian Female subjects.
- •2Healthy 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)
- •3Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar, acneââ?¬Â¦.) Specific criteria
- •4Having wheatish to dark complexion.
- •5Having dry skin.
- •6Subjects who are passing in skin sensitivity test (only for 13 females)
排除标准
- •1Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •2Having refused to give her assent by not signing the consent form
- •3Taking part in another study liable to interfere with this study
- •4Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
- •5Having a progressive asthma (either under treatment or last fit in the last 2 years)
- •6Being epileptic.
- •7Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •8Having cutaneous hypersensitivity
- •9Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •10Following 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)
- •11Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •12Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit
- •13Having applied a cosmetic product (included make-up) or skin care product on the studied areas the day of the study (only face cleaned with water is accepted)
- •14Refusing 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 or skin care products other than the tested products to the studied areas. (only standard facewash is accepted). The day of the measurements: No test product must be used (only face cleaned with water is accepted) Specific criteria
- •15Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months.
- •16Having started, changed or stopped his/her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months
- •17Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoÃ?¯n, amiodarone, metals, minocyclineââ?¬Â¦) in the previous 6 months
- •18Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta caroteneââ?¬Â¦)
- •19Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask ââ?¬Â¦) or having applied self-tanning products in the week preceding the start of the study
- •20Having applied products with anti-wrinkle action (Retinoic acid, retinol, retinaldehyde, isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study
- •21Having applied products with a depigmenting action (hydroquinone or derivatesââ?¬Â¦) in the 4 weeks preceding the start of the study.
- •22Having undergone physical and/or chemical treatments of the spots (liquid ni
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