CTRI/2022/05/042747已完成未知
The objective of this study will be to evaluate the efficacy and safety of a skin care formulation interms of reduction in appearance of wrinkles & fine lines, improvement in skin brightness, skin even tone and skin moisturization on healthy female subjects
Transformative Learning Solution Pvt Ltd0 个研究点目标入组 34 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 34
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 or 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)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar)
- •4) Having uneven skin tone
- •5) Having Crows feet wrinkle according to the Bazins atlas.
排除标准
- •1Being pregnant or breastfeeding or having stopped to breastfeed in the past three months • Having refused to give her assent by signing the consent form
- •2Taking part in another study liable to interfere with this study
- •3Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area
- •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 or food products or to latex
- •10Having known allergy to any of the Ingredient of the Test Product.
- •11Following 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)
- •12Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •13Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit
- •14Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted)
- •15Refusing 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 (only usual cleanser/soap is accepted), The day of the measurements: No test product must be used (only face cleaned with water is accepted)
- •16Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone
- •17Replacement Therapy) during the past 3 months
- •18Having started, changed or stopped her tobacco consumption (for smokers consuming more than
- •1910 cigarettes per day) in the previous 6 months
- •20Having consumed caffeine-based products (coffee, cola, tea), alcohol, highly spiced food
- •21and/or not smoke in the two hours preceding the measurements
- •22Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn,
- •23amiodarone, metals, minocyclineâ?¦) in the previous 6 months
- •24Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta caroten)
- •25Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask) or having applied self-tanning products in the week preceding the start of the study
- •26Having applied products with an anti-wrinkle action particularly firming products (Retinoic acid, retinol, retinaldehyde, Alpha Hydroxy A
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