CTRI/2022/09/045182尚未招募未知
Primary objective: To assess the in-vivo safety and efficacy of Skin care formulation in terms of reduction in Crow�s feet wrinkles, dark circles & improvement in skin moisturization & skin firmness in comparison with untreated area on healthy male & female subjects.
Kama Ayurveda Pvt 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.Indian Male and 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 35 and 50 years of age.
- •4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) Specific criteria
- •5.Having mild to moderate crows feet wrinkles according to the Bazins atlas. [using Page nÃ?° 40 & 41 of Skin Ageing Atlas (Scale: 0 to 6)].
- •6.Having visible under eye dark circles.
- •7.Having under eye wrinkles of grade 2 to 4 according to the Basins atlas [ using Page nÃ?° 46 and 47 under eye Wrinkles of Skin Ageing Atlas (Scale 0 to 8)]
- •8.Having visible Fine lines.
排除标准
- •1For Females: Being 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.
- •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 consumed caffeine-based products (coffee, cola, tea ââ?¬Â¦), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements
- •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) or skin care product on the studied areas the 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 their cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit. Do not have acne prone skin. During the study: Do not use other cosmetic products than the tested products to the studied areas. 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 Replacement Therapy) during the past 3 months
- •17Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months
- •18Having consumed caffeine-based products (coffee, cola, tea, ââ?¬Â¦), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
- •19Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoÃ?¯n, amiodarone, metals, minocyclineââ?¬Â¦) in the previous 6 months
- •20Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta caroteneââ?¬Â¦)
- •21Having 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
- •22Having applied products with anti-wrinkle action (Retinoic acid, retinol, retinaldehyde, isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study
研究者
相似试验
已完成
不适用
Safety and efficacy assessment of Product on skiCTRI/2022/09/045184SkinQ36
尚未招募
不适用
Safety and efficacy of Skin care formulatioCTRI/2022/04/042231Kama Ayurveda Pvt Ltd
尚未招募
不适用
Safety and efficacy assessment of Product on skiCTRI/2022/09/045260SkinQ
已完成
Unknown
Safety and efficacy assessment of Product on skiCTRI/2023/03/050915DPKA UNIVERSAL CONSUMER VENTURES PRIVATE LIMITED52
已完成
2 期
A study of 2-dose Vaccination Regimen of Ad26.ZEBOV and MVA-BN Filo in InfantsPACTR201905827924069Janssen Vaccines and Preventions B.V.107