A randomized, Single-blinded, controlled study to evaluate the effect of Test Product on skin hydration, skin barrier, Luminance for a period of 9 days.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement in skin hydration, skin barrier properties and skin Luminance/radiance/ brightness in comparison to
研究概览
简要总结
This study is a randomized, Single-blinded, controlled study aimed to evaluate the efficacy of test products in improving skin hydration, skin barrier function and its maintenance, and improved skin radiance/luminance compared to baseline at defined time points following the application of test products on the forearm. Subjects will be screened based on inclusion/exclusion criteria and enrolled after providing informed consent. At Visit 1, baseline instrumental and dermatological assessments (hydration, barrier function, dryness, smoothness, and safety) will be conducted after acclimatization. The test, reference, water, and untreated control products will be applied. Visits 2 to 8 will involve product applications. On visit 8, the test products will be applied and the assessments for hydration, barrier function, dryness, smoothness, and safety will be carried out after 30 minutes. On Visit 9, a moisturizer pre-mix will be applied, and efficacy will be assessed at baseline, 30 minutes post-product application and 30 minutes post rinse off of the pre-mix.
study duration: approximately 9 days for each subject excluding screening visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects of Indian origin, in the age group of 19-45 years (both ages inclusive).
- •Subject having Normal to dry skin.
- •Subjects with no cuts, abrasions, wounds, injuries, allergies, tattoos, scars, henna or any other developments/artifacts forearms that can impact the measurements.
- •Subjects willing to give a voluntary written informed consent and agree to come for regular follow-up visits as per the scheduled time.
- •Subjects willing to abide by and comply with the study protocol.
- •Subjects willing to not apply any other products on the test site for the duration of the study.
排除标准
- •A known history or present condition of allergic response to any cosmetic or fragrance-containing products.
- •Subjects under chronic medication (e.g. aspirin-based products, anti- inflammatories, anti-histamines, corticotherapy, etc.) that might influence the outcome of the study or under Systemic treatment or having Chronic illness (diabetes mellitus, hypertension, liver disease, or history of alcoholism, HIV, hepatitis, etc.,) which may modify the cutaneous state on the day of inclusion or in the previous 30 days.
- •Subjects with wounds, sunburn, scars, tattoos, piercings or a history of intense sun exposure/phototoxicity/allergy at the skin test site(s).
- •Subjects with application of ointments, creams etc.
- •for antibacterial, anti- allergic or immunosuppressive treatment of the skin at the test site(s)
- •Subjects who are pregnant or nursing (as confirmed by Urine pregnancy test for the determination of Pregnancy).
结局指标
主要结局
Improvement in skin hydration, skin barrier properties and skin Luminance/radiance/ brightness in comparison to
时间窗: Approximately 9 days for each subject excluding screening.
the Baseline, Reference product and Controls.
时间窗: Approximately 9 days for each subject excluding screening.
次要结局
未报告次要终点
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd.