CTRI/2022/12/048214已完成未知
The objective of this study will be to evaluate efficacy of a skin care formulation in terms of improvement in skin brightness and skin even tone on healthy female subjects.
Transformative Learning Solution Pvt Ltd0 个研究点目标入组 35 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
- 35
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 or Asian 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)
- •4) Having uneven skin tone
- •5) Having wrinkles on Crows feet area with a grade of 2 (mild) to 4 (moderate) according to the
- •Bazin Atlas
- •6) Having dark spot (age spot) and at least one spot of 3.5mm diameter
排除标准
- •1Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •2Having refused to give her assent by signing the consent form
- •3Taking part in another study liable to interfere with this study
- •4Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area
- •5Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
- •6Having a progressive asthma (either under treatment or last fit in the last 2 years)
- •7Being epileptic
- •8Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •9Having cutaneous hypersensitivity
- •10Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex
- •11Having known allergy to any of the Ingredient of the Test Product.
- •12Following 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)
- •13Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •14Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit
- •15Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted)
- •16Refusing 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 than the tested products to the studied areas (only usual cleanser/soap is accepted) ; The day of the measurements: No test product must be used (only face cleaned with water is accepted)
- •17Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months
- •18Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months
- •19Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
- •20Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months
- •21Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta carotene…)
- •22Having 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
- •23Having applied products with an anti-wrinkle action particularly firming products (Retinoic acid, retinol, retinaldehyde, Alpha Hydroxy Acid) in the 2 w
研究者
相似试验
已完成
不适用
Safety & Efficacy assessment of skin care formulatioCTRI/2022/12/048271Transformative Learning Solution Pvt Ltd30
尚未招募
Unknown
Evaluation of safety & Efficacy of skin care formulatioCTRI/2023/04/051461Transformative Learning Solution Pvt Ltd
已完成
不适用
Evaluation of safety & Efficacy of skin care formulatioCTRI/2022/06/043455Transformative Learning Solution Pvt Ltd35
已完成
不适用
Assessment of safety & Efficacy of cosmetic productCTRI/2023/02/050012Transformative Learning Solution Pvt Ltd32
已完成
不适用
Evaluation of safety of productCTRI/2022/05/042477Transformative Learning Solution Pvt Ltd120