CTRI/2023/02/049955已完成未知
The Objective of this study will be to evaluate the efficacy and safety of an eye care formulation i.e.Tulsi Mint Tonifying Eye Gel in terms of visible reduction in appearance of crow’s feet, wrinkles and fine lines, under eye dark circles & eye-bags on healthy female subjects.
Transformative Learning Solution Pvt Ltd0 个研究点目标入组 61 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
- 61
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)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) Specific criteria
- •4)Having eye-bags.
- •5)Having wrinkles on Crows feet area with a grade of 2 (mild) to 4 (moderate) according to the Bazins Atlas. using Page n° 40 of Skin Ageing Atlas (Scale: 0 to 6).
- •6)Having under eye dark circles.
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 not 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.
- •11)Having known allergy to any of the Ingredient of the Test Product.
- •12)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)
- •13)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •14)Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
- •15)Having applied a cosmetic product(included make-up) or skin care product on the studied areas the first day of the study (only face cleaned with water is accepted)
- •16)Refusing 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 or skin care product than the tested products to the studied areas (only usual cleanser/soap is accepted) - The day of the measurements: No cosmetic product must be used (only face cleaned with water is accepted)
- •17)Having started, changed or stopped a Hormone Replacement Therapy in the past 6 months
- •18)Having started, changed or stopped a diuretic or phlebotonic treatment in the past 3 months.
- •19)Having started, changed or stopped his/her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months
- •20)Having taken a Dehydroepiandrosterone based treatment in the previous 6 months.
- •21)Having applied products with an anti eye-bags and/or anti dark circle and/or anti-wrinkle action particularly firming products (Retinoic acid, retinol, retinaldehyde, Alpha Hydroxy Acid ….) in the 2 weeks preceding the start of the study.
- •22)Having made injections of anti-wrinkle products (collagen, hyaluronic acid, botulinic toxin…) in the previous 12 months
- •23)Having undergone techniques with aesthetic aim (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp …) in the previous year
- •24)Having undergone surgery of the ski
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