CTRI/2023/03/050912尚未招募不适用
Primary Objective: To evaluate the efficacy Skin Care Formulation in terms of Skin Brightening Effect on healthy female subjects. Secondary Objective: To evaluate the in-vivo safety and efficacy of a skin care formulation 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: 2023年3月24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 Effect.
研究概览
简要总结
PRIMARY OBJECTIVE:
The objective of this study will be to assess the efficacy of Skin Care Formulation in terms of Skin
Brightening Effect on healthy female subjects coded
SECONDARY OBJECTIVE:
To evaluate the in-vivo safety and efficacy of a skin care formulation in terms of Improvement in
Skin Water Barrier Function and in Skin Smoothness on healthy female subjects coded
Duration of study: 28 days study
Kinetics: T0,T+30 minutes, T+7 days,T+14 days & T+28 days
Population: 56 (44 Varied skin volunteers +12 sensitive skin) volunteers
The evaluation is performed using:
Subject Self Evaluation
Dermatological Evaluation: Cosmetic Acceptability
Chromametry
Tewametry
Illustrative photographs of face under diffused 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
- 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.Between 18 and 50 years of age 4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) Specific criteria 5.44 Subjects representing varied skin types (ideally equal representation of all 4 skin types – Oily, Normal, Dry and Combination)+13 sensitive skin (declared through lactic acid sting test).
- •6.Having wheatish to dark complexion.
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 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) 9Having cutaneous hypersensitivity 10.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex 11.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) 12.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 13.Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit 14.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). 15.Do not take part in any family planning activities leading to pregnancy and breastfeeding 16.Do not take part in another study liable to interfere with this study 17.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) 18.Do not change her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit 19.During the study: Do not use other cosmetic products than the tested products to the studied areas (only usual cleanser/soap is accepted) 20.The day of the measurements: No test product must be used (only face cleaned with water is accepted) 21.Having started, changed or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy) in the past 3 months. 22.Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months 23.Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months 24.Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta￾ carotene…) 25.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 26.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 27.Having applied products with a depigmenting action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study. 28.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 29.Having a suntanned skin on the studied areas which could interfere with the evaluations of the study. 30.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 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 action.
- •Do not practice sport the days of study.
- •Do not expose yourself to the sun by respecting a strict photo-protection.
结局指标
主要结局
Skin Brightening Effect.
时间窗: Baseline,30 minutes ,7 days,14 days and 28 days
次要结局
- Improvement in Skin Water Barrier Function and Skin Smoothness.(Baseline,30 minutes,7 days,14 days and 28 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Safety & Efficacy assessment of skin care formulationCTRI/2022/12/048271Transformative Learning Solution Pvt Ltd36
尚未招募
不适用
Evaluation of safety and efficacy of skin care formulationCTRI/2022/08/044896DPKA Universal Consumer Ventures Private Limited56
已完成
不适用
Evaluation of safety & Efficacy of skin care formulationCTRI/2022/05/042747Transformative Learning Solution Pvt Ltd36
已完成
不适用
Assessment of safety & Efficacy of cosmetic productCTRI/2023/02/050012Transformative Learning Solution Pvt Ltd36
已完成
不适用
Assessment ofsafety & Efficacy of cosmetic productCTRI/2022/12/048214Transformative Learning Solution Pvt Ltd36