CTRI/2022/11/047232尚未招募不适用
To evaluate the in-vivo efficacy and safety of a skin care formulation in terms improvement in skin radiance, skin brightness, skin smoothness, Skin firmness and reduction in intensity of dark spoton healthy female subject.
VEDISTRY PVT LTD.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年11月16日
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Improvement in
研究概览
简要总结
Secondary Objective: To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of improvement in skin radiance, skin brightness, skin smoothness, Skin firmness and reduction in intensity of dark spoton healthy female subjects.
Duration of study: 28 days study
Kinetics: T0, T+15 Minutes after product application, T+14 days and T+28 days
Population: 36 Female volunteers
The evaluation is performed using:
1 1. Subject’s Self Evaluation, 2 Dermatological Evaluation: Cosmetic Acceptability, 3 Dermatological Evaluation: Efficacy, 4 Chromametry , 5 Mexametry , 6 CLBT , 7 Cutometry
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1Indian female subjects.
- •2Healthy 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) 3Between 18 and 45 years of age.
- •4Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).
- •5Having wheatish to dark complexion.
- •6Having dark spot (acne PIH) on face and at least one spot of 3.5 mm diameter.
排除标准
- •For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •For Male: Shave beard 1day prior before visit
- •Having refused to give his/her assent by not signing the consent form
- •Taking part in another study liable to interfere with this study
- •Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
- •Having acne prone skin.
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
- •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).
- •Having cutaneous hypersensitivity.
- •Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
- •Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted)
- •Refusing to follow the restrictions below during the study: For Females: 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 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)
- •Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months.
- •Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months.
- •Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
- •Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months
- •Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta carotene…)
- •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
- •Having applied products with a depigmenting/ whitening action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.
- •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
- •Having a suntanned skin on the studied areas which could interfere with the evaluations of the study.
- •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 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
Improvement in
时间窗: Baseline, 15 minutes | after product | application, Day14, Day28
skin radiance, skin brightness, skin smoothness, Skin firmness and reduction in intensity of dark spot
时间窗: Baseline, 15 minutes | after product | application, Day14, Day28
次要结局
未报告次要终点
研究者
研究点 (1)
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