CTRI/2023/02/049683尚未招募不适用
To evaluate & compare the in vivo safety & efficacy in terms of moisturizing effect of skin care formulations versus untreated control on healthy male and female subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Percent improvement in capacitance value i.e skin moisturization
研究概览
简要总结
The objective of thisstudy will be to evaluate & compare the in vivo safety & efficacy interms of moisturizing effect of skin care formulations versus untreated controlon healthy female subjects.
The evaluation is performed using:
1. Subject Self Evaluation (SSE)
2. Dermatological Evaluation: Cosmetic Acceptability
**3.**Corneometry
**4.**Tewametry
Study Population :33 (16/17 male and 16/17 female) subjects
Study Duration: 24 hours following the application ofthe product
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 65.00 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 18 and 65 years of age.
- •4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).
- •5.Having dry skin on forearms.
排除标准
- •1.For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
- •2.Having refused to give his/her assent by not signing the consent form and Informed consent form 3.Taking part in another study liable to interfere with this study 4.Being known diabetic case 5.Known asthma case 6.Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 7.Being known thyroid case 8.Being epileptic.
- •9.Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticosteroid therapy, taken by general or local routes or corticosteroid by any route (the only medication permitted is paracetamol) 10.Known case of hypersensitivity.
- •11.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •12.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •13.Having changed their cosmetic habits except those required by the protocol 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 48 hours prior study.
- •15.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, corticosteroid therapy, taken by general or local routes (the only medication permitted is paracetamol).
- •Do not change 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 product to the studied areas.
- •16.Having started, changed, or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy, thyroid…) in the past 3 months.
- •17.Having taken an oral retinoid-based treatment in the past 6 months 18.Having taken a local retinoid-based treatment on the studied areas in the previous month 19.Having had beauty treatment (e.g. scrub, manicure, self-tanning product …) in the previous week 20.Having practiced water activities (swimming pool, sauna, hammam, baleneotherapy etc.) in the previous week.
- •21.Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements 22.Having practiced intensive sports during the day prior to the T0 measurements 23.Having wounds, scars, sunburns, tattoos and piercing on test site.
- •24.Having hair on test site.
- •25.Having applied another product than water on the studied areas in the morning of the T0 measurements 26.Having had an intensive UV exposition on the inner forearm (solariums, sun) prior to T0 measurements.
- •27.Having used moisturizing products on the arms during 24 hours prior to T0 measurements.
- •28.Refusing to follow the restrictions below during the study: -Do not have beauty treatment (e.g. scrub, manicure self-tanning product …) -Do not practice water activities (swimming pool, sauna, hammam, balneotherapy etc.) -Do not drink/ eat caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food, nor smoke -Do not practice sport -Do not apply any product on inner forearm including water.
- •Do not wipe their inner forearm.
- •Do not wear jewels on the wrists.
- •Do not have an intensive UV exposition on the arms (solariums, sun).
结局指标
主要结局
Percent improvement in capacitance value i.e skin moisturization
时间窗: Baseline, 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours & 24 hours
次要结局
- prevention of the water loss from skin(Baseline, 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours & 24 hours)
研究者
研究点 (1)
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