CTRI/2022/09/045182尚未招募不适用
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 Ltd1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年5月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety, Reduction in Crow’s feet wrinkles, dark circles & improvement in skin moisturization & skin
研究概览
简要总结
Objective:
The objective of this study will be to assess the 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
Duration of study: 28 days study
Kinetics: T0, T+30 minutes, T+1 day, T+3 days and T+28 days
Population: 40 (20 Females & 20 Males) volunteers
The evaluation is performed using:
1 Subject Self Evaluation
2 Dermatological evaluation: CosmeticAcceptability
3 Ophthalmological Evaluation: Safety
4 Dermatological evaluation: Efficacy
5 Cutometry
6 Corneometry
7 Tewametry
8 Analysis of the skin color through crosspolarized light
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
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 n° 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 n° 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 …), 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, …), 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 (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months 20Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta carotene…) 21Having 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 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 23Having applied products with a depigmenting/ whitening action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study. 24Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel …) in the previous 6 months 25Having a suntanned skin on the studied areas which could interfere with the evaluations of the study. 26Refusing to follow the restrictions below during the study:.
- •Do not start, change or stop a hormonal treatment (hormonal contraception, Hormone Replacement Therapy).
- •Do not start a medicinal treatment which could lead to hyper pigmentation.
- •Do not take oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…).
- •Do not consume caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements.
- •Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) or apply self tanning products.
- •Do not use products or techniques or surgery with a depigmenting / whitening action.
- •Do not expose herself to the sun by respecting a strict photo-protection.
结局指标
主要结局
Safety, Reduction in Crow’s feet wrinkles, dark circles & improvement in skin moisturization & skin
时间窗: Baseline, Day 1, day 3 and Day 28
firmness
时间窗: Baseline, Day 1, day 3 and Day 28
次要结局
未报告次要终点
研究者
研究点 (1)
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