CTRI/2022/08/044896尚未招募不适用
PRIMARY OBJECTIVE: To assess the efficacy of skin care regime in terms of Skin Brightening Effect on healthy female subjects SECONDARY OBJECTIVE: To evaluate the in-vivo safety and efficacy of a skin care regime in terms of Improvement in Skin Water Barrier Function and in Skin Smoothness on healthy female subjects
DPKA Universal Consumer Ventures Private Limited1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2022年8月28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
- 56
- 试验地点
- 1
- 主要终点
- skin brightening, skin safety
研究概览
简要总结
PRIMARY OBJECTIVE: The objective of this study will be to assess theefficacy of skin care regime in terms of Skin Brightening Effect on healthyfemale subjects.
SECONDARY OBJECTIVE: To evaluate the in-vivo safety and efficacy of askin care regime in terms of Improvement in Skin Water Barrier Function and inSkin Smoothness on healthy human subjects.
Test Product: SUNSCREEN DROPS: ProductA
The evaluation is performedusing: Subject’s Self Evaluation, Dermatological Evaluation: Safety,Dermatological Evaluation: Efficacy, Chromametry, Tewametry, Illustrativephotographs of face under diffused light.
Total duration of the study: 28 daysfollowing the first application of product.
Kinetics: T0, T+30 minutes afterproduct application, T+7 days, T+14 days and T+28 days
Number of volunteers: 56 (43 normalskin volunteers +13 sensitive skin)
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
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Indian / 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….) Specific criteria 4.43 normal skin volunteers +13 sensitive skin (declared through lactic acid sting test).
- •5.Having wheatish to dark complexion.
- •6.Having visible dry skin.
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 Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 5 Having a progressive asthma (either under treatment or last fit in the last 2 years) 6 Being epileptic. 7 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8 Having cutaneous hypersensitivity 9 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 10 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) 11 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 12 Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit 13 Having 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) 14 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 products other than the tested products to the studied areas. (only standard facewash is accepted). The day of the measurements: No test product must be used (only face cleaned with water is accepted) Specific criteria 15 Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months. 16 Having started, changed or stopped his/her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months 17 Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months 18 Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta carotene…) 19 Having 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 20 Having applied products with anti-wrinkle action (Retinoic acid, retinol, retinaldehyde, isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study 21 Having applied products with a depigmenting action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study. 22 Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel …) in the previous 6 months 23 Having a suntanned skin on the studied areas which could interfere with the evaluations of the study 24 Refusing 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 use products or techniques or surgery with a depigmenting.
- •Do not take oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…).
- •Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) or apply self tanning products action.
- •Do not swim in artificial water bodies (pools, hot tubs etc.…).
- •Do not expose herself to the sun by respecting a strict photo-protection.
结局指标
主要结局
skin brightening, skin safety
时间窗: Baseline, 30 min after product application, 7 days, 14 days and 28 days
次要结局
- Improvement in Skin(Water Barrier Function and in Skin Smoothness)
研究者
研究点 (1)
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