A randomized, double-blinded, controlled study to evaluate the efficacy of test products in providing skin moisturization and barrier protection for up to 24 hours in healthy subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- 2. To evaluate the retention of skin moisturization for immediate, 4 hours, 8 hours, and 24 hours using Corneometer – CM 825 with a single application of the test product in comparison to the untreated site.
研究概览
简要总结
The study is designed to evaluate the moisturization benefits of multiple products and maintenance of efficacy for 24 hours in comparison to the baseline and the untreated site/ control site/s by an investigator-blinded, permuted, randomized, comparative and controlled study.
35 healthy female subjects after satisfying the inclusion exclusion criteria will be enrolled of which 30 subjects is required to complete the study. Post enrolment, the participants will undergo a Washout period for 5±2 days. After wash-out participants will be asked to report for the assessment visit in the morning and asked to wash their forearms with water and tap dry with paper towels. The products and control will be allotted as per randomization. After completion of baseline measurements, study personnel will apply the test products to the test product sites as per the randomization and assessment will be done at different time intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator 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
- •Healthy female subjects, as determined from a recent medical history.
- •Subjects in the age group of 18-45 years (both ages inclusive).
- •Subjects who present normal to dry skin on the forearm (corneometer value of 35 as maximum)
- •Healthy skin in the test sites.
- •Subjects willing to give voluntary written informed consent and agree to come for regular follow-up.
- •Subjects willing to abide by and comply with the study protocol.
- •Subjects who are willing not to participate in any other clinical study during participation in the current study.
排除标准
- •Excessive hair on the test site
- •A known history or present condition of an allergic response to any cosmetic products.
- •Change personal nutrition habits as well as sports habits
- •Start or change their oral hormonal treatment or their oral contraception.
- •Subject having active skin diseases (e.g., active atopic dermatitis, pigmented contact dermatitis or other cutaneous manifestations), which will interfere with the assessment.
- •Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study.
- •Subjects had cancer in the last 10 years
- •Subjects with wounds, sunburn, scars, tattoos or piercings at the skin test site(s)
- •Subjects with application of ointments, creams etc.
- •for antibacterial, antiallergic or immunosuppressive treatment of the skin at the test site(s) 10.Systemic treatment which may modify the cutaneous state on the day of inclusion or in the previous 30 days, including retinoid therapy.
- •History of intense sun exposure and/ photo toxicity/allergy.
- •12.Female subjects who are pregnant, lactating or nursing.
- •14.Subject participating in any other cosmetic or therapeutic trial.
结局指标
主要结局
2. To evaluate the retention of skin moisturization for immediate, 4 hours, 8 hours, and 24 hours using Corneometer – CM 825 with a single application of the test product in comparison to the untreated site.
时间窗: Baseline, Immediate, 4 hours, 8 hours and 24 hours
3. To evaluate the deep moisturization: TEWL with a single application of the test product in comparison to the untreated site.
时间窗: Baseline, Immediate, 4 hours, 8 hours and 24 hours
1. To evaluate and compare skin moisturization using Corneometer – CM 825 with a single application of the test product in comparison to the baseline and untreated control.
时间窗: Baseline, Immediate, 4 hours, 8 hours and 24 hours
4. To measure and compare TEWL at immediate, 4 hours, 8 hours, and 24 hours with a single application of the test product in comparison to the baseline and untreated control.Â
时间窗: Baseline, Immediate, 4 hours, 8 hours and 24 hours
次要结局
- To evaluate the efficacy based on the dermatological visual assessment at immediate, 4 hours, 8 hours, and 24 hours with a single application of the test product compared to the baseline and untreated control.(Baseline, Immediate, 4 hours, 8 hours and 24 hours)