CTRI/2020/02/023496尚未招募未知
To evaluate the in-vivo safety and efficacy of skin care formulation in terms of non comedogenic effect, skin lightening effect and even skin tone in healthy male and female subjects. - Not Applicable
Adroit Biomed Ltd0 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
- •1) Healthy Indian / Asian males and female subjects
- •2) 36 subjects aged between 18 and 60 years old will be selected for the study
- •a)Having oily to mixed oily skin on the face
- •b)Having wheatish to dark complexion &
- •c)Having atleast one well defined superficial hyper-pigmentory spot ( >3.5mm in diameter)
- •3) Volunteer willing to participate in the study and provide signed informed consent for the same
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 months)
- •9) Having 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 months.
- •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) Having started, changed or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy) in the past 3 months.
- •16) Having started, changed or stoppedher tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months
- •17) Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocyclineâ?¦) in the previous 6 months
- •18) Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-caroteneâ?¦)
- •19) 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
- •20) 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
- •21) Having applied products with a depigmenting action (hydroquinone or derivatesâ?¦) in the 4 weeks preceding the start of the study.
- •22) Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel â?¦) in the previous 6 months
研究者
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