Assessment of Moisturekinetic and Skin Barrier Repair Parameters of Test Product(s) in Healthy Adult Male and Female Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- 1. To assess the effectiveness of the test product in terms of change in skin barrier repair using Tewameter TM Hex.
研究概览
简要总结
Evaluation of Moisturekinetic and skin barrier in healthy adult male and female subjects.
A total of up to 26 healthy adult male and non-pregnant/non-lactating females with an age of 18-55 years will be enrolled to ensure a total 24 evaluable subjects complete the study.
Visit 1(Day 01): Screening Phase
Visit 2(day 02): Enrolment Phase, Test Product Usage, Evaluation
Visit 3 (Day 03): 24 hours post application evaluation, test product usage period
Visit 4 (Day 14): Telephonic follow-up
Visit 4(Day 28): Evaluation, End of the study
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
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 18 to 55 years(both inclusive) at the time of consent.
- •Sex: Healthy male and non-pregnant/non-lactating female.
- •Females of childbearing potential must have a self-reported negative urine pregnancy test.
- •Subjects with skin hydration less than 40 percentage at application site though the instrumental assessment and as per the dermatologist ( for dry skin subjects) 5.Subject is in good general health as determined by the Investigator on the basis of medical history.
- •6.Subjects should be willing and able to follow the study protocol to participate in the study.
- •7.Subject must be able to understand and provide written informed consent to participate in the study.
- •8.Subject is willing to refrain from vigorous physical exercise during the study period.
- •9.Subjects is willing not to use any other marketed product on application site during the study visit.
排除标准
- •1.Subject has any known allergy to test product ingredient.
- •2.Presence of any chronic disease or illness in the past three months or any clinically significant on-going chronic medical illness e.g. Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc.
- •3.Participation in any similar clinical trial within the past 90 days.
- •4.Currently have any allergies or chronic allergies or sensitivities to soaps, shampoos, conditioners, or any other skin care products as well as fragrances.
- •5.Currently using any topical medications.
- •6.Consume any alcoholic beverages during the days of the study.
- •7.Pregnant or lactating females.
- •8.Self-reported Positive HIV test.
- •9.History of Hepatitis B or C virus self-reported.
- •10.Have any other condition or factor that the Investigator believes may affect interpretation of the results.
结局指标
主要结局
1. To assess the effectiveness of the test product in terms of change in skin barrier repair using Tewameter TM Hex.
时间窗: Baseline before application of the test product to after application at T0 (20 mins), T1 (01 hrs), and T2 (12 hrs) on Day 01, T24 hrs on Day 2, and 28 Days post usage.
2.To assess the effectiveness of the test product in terms of change in skin hydration using MoisturemeterEpiD/ Corneometer CM 825.
时间窗: Baseline before application of the test product to after application at T0 (20 mins), T1 (01 hrs), and T2 (12 hrs) on Day 01, T24 hrs on Day 2, and 28 Days post usage.
3. To assess the effectiveness of the test product in terms of change in skin texture using MoisturemeterEpiD/ Corneometer CM 825.
时间窗: Baseline before application of the test product to after application at T0 (20 mins), T1 (01 hrs), and T2 (12 hrs) on Day 01, T24 hrs on Day 2, and 28 Days post usage.
4.To assess the effectiveness of the test product in terms of change in skin dryness, redness, smoothness, roughness, itchiness, and scaliness at application site by dermatologist and dermatologist trained evaluator.
时间窗: Baseline before application of the test product to after application at T0 (20 mins), T1 (01 hrs), and T2 (12 hrs) on Day 01, T24 hrs on Day 2, and 28 Days post usage.
次要结局
- 1.To evaluate the efficacy of the test product in terms of subjective product perception questionnaire using 9-point hedonic scale.(2. To assess the safety of the test product in terms of adverse events reported by subjects or assessed by the Investigator)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited