CTRI/2023/03/050915已完成Unknown
Primary Objective: To evaluate the in-vivo efficacy and safety of a skin care regime in terms of improvement in the Moisturisation, pH balance, radiance and skin smoothness, Reduction in sebum on healthy female subjects.Secondary Objective: To evaluate the efficacy and safety of a skin care regime in terms of Improvement in skin brightness on healthy female subjects.
DPKA UNIVERSAL CONSUMER VENTURES PRIVATE LIMITED0 个研究点目标入组 52 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 52
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 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 scar….)
- •5)Having all skin type.30 oily skin ,10 normal skin , 10 subjects with sensitive skin (declared through lactic acid sting
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, minocycline…) in the previous 6 months
- •24.Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta
- •25.Having 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
- •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 derivates…) in the 4 weeks
- •preceding the start of the study.
- •28.Having under
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