An exploratory, evaluator-blinded, randomized, interventional, prospective proof-of-concept Study to assess the safety and efficacy of two test products in individuals with mild to moderate crows feet wrinkles associated with acne, photoaging, and chronological aging.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- 1.To evaluate the effectiveness of the test products in terms of change in skin elasticity from baseline before usage and after usage of the test products, and between test products by using Cutometer.
研究概览
简要总结
This is an exploratory, evaluator-blinded, randomized, interventional, prospective, proof of concept, safety and efficacy study of two test products in subjects mild to moderate crow’s feet wrinkles associated with acne, photoaging, and chronological aging.
A total of 34 non-pregnant, non-lactating females (17 females/product) aged 30 to 55 years (inclusive), will be enrolled to ensure that 30 subjects (15 females/product) complete the study.
The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects.
The subjects will be instructed to visit the facility as per the below visits.
Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation
Visit 02 (Day 30): Test Product Usage, Evaluations
Visit 03 (Day 60): Final Evaluation, End of Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age: 30 to 55 years (both inclusive) at the time of consent.
- •Sex: Adults female having Crow’s feet area wrinkles and fine lines.
- •Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit.
- •Subjects should not have used any cosmetic, nutraceutical or therapeutic products for skin ageing in last 6 months.
- •Subjects must be willing to stop using any cosmetics or any medical products for skin ageing for the duration of the study.
- •Subjects are not allowed to participate in any other study until this study is complete.
- •Subjects must be willing and able to follow the study directions and to return for all specified visits with the product.
- •Subjects must agree to record each use of the test products in the subject’s diary card on daily basis.
- •Subjects must agree to record medication use during the study.
排除标准
- •Subjects who are on steroids for last six months.
- •Subjects who have used any cosmetic, nutraceutical or therapeutic products for skin last six months.
- •Subjects who are on product which contains kojic acid, glycolic acid, niacinamide, alpha arbutin, Vitamin C and other skin ageing product.
- •Subjects with other dermatologic diseases whose presence or treatments could interfere with the assessment of study.
- •Subjects that are pregnant and/or breastfeeding.
- •The subject has a known allergy or sensitivity to soaps, lotions, detergents, detanglers or fragrances.
- •Subjects if do not agree to limit sun exposure to affected areas such as face during prolonged sun exposure.
- •The subject has any other skin conditions i.e. cuts, scratches, ring worms, etc.
- •which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the subject.
- •The subject has any of the conditions or factors that the Investigator believes may affect the response of the skin or the interpretation of the test results.
- •The subject is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data.
结局指标
主要结局
1.To evaluate the effectiveness of the test products in terms of change in skin elasticity from baseline before usage and after usage of the test products, and between test products by using Cutometer.
时间窗: On Day 01, on Day 30 and Day 60
2.To evaluate the effectiveness of the test products in terms of change in skin texture i.e. skin roughness, smoothness, scaliness, wrinkles, and fine lines from baseline before usage and after usage of the test products, and between test products by using VISIOSCAN VC 20 Plus.
时间窗: On Day 01, on Day 30 and Day 60
次要结局
- 1.To evaluate the effectiveness of the test products in terms of changes in wrinkles and finelines from baseline before usage and after usage of the test products, and between test products by using scoring scale.
- 2.To evaluate the effectiveness of the test products in terms of subjective product perception(and non-comedogenic questionnaire assessment by using scoring scale)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited