CTRI/2022/09/045309尚未招募未知
Primary objective: To assess the in-vivo efficacy and safety of a skin care formulation in terms improvement in skin brightness & luminosity on healthy female subjects. Secondary objective: To assess the in-vivo efficacy and safety of a skin care formulation in terms improvement in skin even tone, & reduction in melanin content of pigmentary spots (Acne PIH &/or melasma)on healthy female subjects.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- SkinQ
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)
- •3Between 18 and 45 years of age.
- •4Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarââ?¬Â¦.)
- •5Having Fitz Patrick Skin type III-IV.
- •6Some subjects having visible melasma and some subjects having dark spot (acne PIH) on face (with at least one dark spot >4mm in diameter)
排除标准
- •1For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •Having refused to give his/her assent by not signing the consent form
- •Taking part in another study liable to interfere with this study
- •Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
- •Having acne prone skin.
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
- •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).
- •Having cutaneous hypersensitivity.
- •Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
- •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)
- •2Refusing 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 his/her cosmetic habits apart from the p.articular conditions mentioned in the protocol, on the studied anatomic unit. Do not practice water activities (swimming pool, sauna, hammam, balneotherapy) During the study: Do not use other cosmetic products than the tested products to the studied areas. Do not use hair oil. The day of the measurements : No other cosmetic products must be used (only face cleaned with water is accepted)
- •3Having started, changed or stopped a Hormone Replacement Therapy in the past 6 months.
- •4Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months.
- •5Having taken a Dehydroepiandrosterone based treatment in the previous 6 months.
- •6Having applied products with an anti-wrinkle action particularly firming products (Retinoic acid, retinol, retinaldehyde, Alpha Hydroxy Acidââ?¬Â¦.) in the 2 weeks preceding the start of the study.
- •7Having made injections of anti-wrinkle products (collagen, hyaluronic acid, botulinic toxinââ?¬Â¦) in the previous 12 months.
- •8Having undergone techniques with aesthetic aim (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp ââ?¬Â¦) in the previous year.
- •9Having undergone surgery of the skin-muscular slackening on the face (lifting) in the previous 5 years.
- •10Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta caroteneââ?¬Â¦)
- •11Having applied products with a depigmenting action (hydroquinone or derivatesââ?¬Â¦) in the 4 weeks preceding the start of the study.
- •12Having undergone phy
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