Prospective, Interventional, Proof-of-Science, Randomised, Evaluator-Blinded, In-Use Safety and Efficacy Study of Two Moisturising Creams in Wound-Healing.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- 1. To assess the efficacy of the test products in healing of the wounds on skin, in terms of change in skin barrier function.
研究概览
简要总结
This is an evaluator-blinded, in-use safety and efficacy study of wound-healing properties of two test products.
A maximum of 17 subjects will be recruited to ensure the completion of the study with a total of 15 subjects.
Subjects will be instructed to visit the facility for the following scheduled visits:
- Visit 1: Day (-01): Screening, Enrolment, Site cleaning, Site demarcation, Baseline Scoring, Instrument Evaluations, 24 hours patch Application
- Visit 2: (Day 01 (24 hours post patch application): Patch removal, irritation scoring, instrumental evaluations, 24 times tape stripping on designated sites, application sites photographs, product Application to the sites, instrumental evaluation post-dose
- Visit 03 [Day 02 (24 hours post dose) + 1 day]: Irritation Scoring, Instrument Evaluation
- Visit 04 [Day 03, (48 hours post dose) + 1 day]: Irritation Scoring, Instrument Evaluations
- Visit 05 [Day 07 + 1 day]: Irritation Scoring, Instrument Evaluations, Application Sites Photograph
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •The subject is aged between 18 and 55 years (both inclusive) at the time of informed consent.
- •The subject is a non-pregnant, non-lactating healthy adult female.
- •No previous history of adverse skin conditions, and not under any medication likely to interfere with the results.
- •The subject has a self-reported negative urine pregnancy test.
- •The subject is in a good general health as determined from recent medical history.
- •The subject has willingness and ability to adhere to study directions, and agrees not to use any other skin creams, lotions, serums, etc.
- •at the application sites, except for the specified test products, and return for all specified visits.
- •The subject possesses the ability to comprehend and provide written informed consent for participation in the study.
排除标准
- •The subject is currently pregnant or lactating or is planning to become pregnant during the study period.
- •The subject has a history of allergies or specific allergic reactions upon using dermatological or cosmetic products.
- •The subject is currently enrolled in an active investigational study or has participated in an investigational study within 30 days prior to enrolment.
- •The subject suffers from any active clinically significant disease or any condition that according to the discretion of the investigator warrants exclusion from the study.
- •The subject is taking or has taken a medication which, in the judgement of the Investigator, makes the subject ineligible or places the subject at undue risk.
结局指标
主要结局
1. To assess the efficacy of the test products in healing of the wounds on skin, in terms of change in skin barrier function.
时间窗: On Day -01, at two time-points on Day 01 (pre-dose and post dose at T12 hours), and subsequently on Days 02, 03, and 07.
2. To assess the efficacy of the test products in healing of the wounds on skin, in terms of change in skin hydration.
时间窗: On Day -01, at two time-points on Day 01 (pre-dose and post dose at T12 hours), and subsequently on Days 02, 03, and 07.
3. To assess the efficacy of the test products in healing of the wounds on skin, by evaluating the skin surface topography in terms of skin roughness, wrinkles, scaliness, smoothness, and a 3D skin ultrasound.
时间窗: On Day -01, at two time-points on Day 01 (pre-dose and post dose at T12 hours), and subsequently on Days 02, 03, and 07.
次要结局
- 1. To assess the efficacy of the test products in healing of the wounds on skin, in terms of change in skin irritation, dryness, scaling, peeling, itching, swelling, and smoothness.(On Day -01, at two time-points on Day 01 (pre-dose and post dose at T12 hours), and subsequently on Days 02, 03, and 07.)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited