CTRI/2025/11/097185尚未招募不适用
Evaluation of the moisturization effect of skin care formulation (Cebhydra Intense)
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
研究概览
简要总结
OBJECTIVE:The objective of this study is to evaluate the moisturization effect of skincare formulation – Cebhydra Intense on healthy human male & female subjects.The evaluation will be performed using: Subject Self Evaluation (SSE) Questionnaire (Moisturization Effect & Safety), Subject Self Evaluation (SSE) Questionnaire (Cosmetic Appeal), Dermatological Evaluation: Safety, Dermatological Evaluation: Skin Softness, Corneometry, and Tewametry.
STUDY POPULATION: About 16–17 male and 16–17 female subjects will be selected for this study.
Enrollment: 16–17 male and 16–17 female subjects will be enrolled. Completion: 15 male and 15 female subjects are expected to complete the study.
The subjects to be selected for this study will be healthy males and females aged between 18 and 40 years, having dry skin on the inner forearms with a corneometer reading of <30.
STUDY DURATION: The study will last for 24 hours for each subject following the application of the product on the forearm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •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 40 years of age.
- •Skin is healthy on the studied anatomic unit (e.g., free of eczema, wounds, inflammatory scar).
- •Having dry skin on inner forearms with corneometry reading of less than 30.
排除标准
- •For Female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
- •Having started, changed or stopped a hormonal treatment (e.g., hormonal contraception, Hormonal Replacement Therapy, thyroid) in the past 3 months 3)Having taken an oral retinoid-based treatment in the past 6 months.
- •Having had a local retinoid-based treatment on the studied areas in the previous month.
- •Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask) in the previous week 6)Having applied a moisturizing product on the studied areas in the 5 days preceding the start of the study.
- •(only hands cleaned with water is accepted) 7)Having practiced water activities (swimming pool, sauna, hammam, baleneotherapy etc.) in the previous week 8)Having consumed caffeine-based products (coffee, cola, tea), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements 9)Having practiced intensive sports during the day prior to the T0 measurements 10)Having wounds, Scars, sunburns, tattoos and piercing on test site.
- •Having applied another product than water on the studied areas in the morning of the T0 measurements 12)Having had an intensive UV exposition on the forearms (solariums, sun) during 5 days prior to T0 measurements.
- •Having used any skin care products as well as skin care cleansers such as bath/shower oils on the forearms during 5 days prior to T0 measurements.
- •Having hair on test site.
- •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), During the study: Do not use other cosmetic products than the tested product to the studied areas, 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 forearms including water, Do not wipe their inner forearms, Do not wear jewels on the wrists, Do not have an intensive UV exposition on the inner forearms (solariums, sun).
- •Between T0 and T+24 hours after Product application measurements:Do not use skin care products on the inner forearms, Do not wash the inner forearms, Do not use surfactant containing product on the test site on inner forearms, Daily morning hygiene with water accepted except on inner forearms.
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.
研究点 (1)
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