To evaluate the efficacy of the test product in providing Anti- Ageing Benefits in Healthy Human Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- 1. Improvement in skin firmness or elasticity in comparison to baseline at different timepoints.
研究概览
简要总结
This study aims to evaluate the efficacy and safety of a test product in reducing signs of aging, such as wrinkles and spots, over a 4-week period in healthy male and female volunteers. A total of 38 subjects will be screened. Upon enrolment, subjects will undergo baseline assessments including dermatological evaluation and instrumental assessments, followed by self-assessment. Throughout the study, subjects will apply the test product twice daily and will attend assessment visits at 72 hours, week 2, and week 4. Compliance will be monitored, and assessments will include dermatological evaluations, instrumental assessments, and self-assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects in the age group of 20-55 years (both ages inclusive).
- •Subject presenting at least 2 well defined dark spots of PIH/Acne/Age spots on either side of the face.
- •Subject identified for fine lines of score 4 and above and wrinkles of score 2 and above
- •Subjects with skin phototype III to V.
- •(10% of the subjects to be phototype V).
- •Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face as determined by the dermatologist.
- •Subject who agrees not to use any other product/treatment/home remedy/ except the provided product on their face during the study period other than the test product.
排除标准
- •1.Subject with any other signs of significant local irritation or skin disease.
- •Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data.
- •Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year.
- •Subjects undergoing any treatment of any skin condition on their face.
- •Subjects not willing to discontinue other topical facial products.
- •Subject allergic or sensitive to bar, cleansing products, cosmetics, creams/lotions, artificial jewelry or anything else.
- •Subjects who are pregnant and lactating (Self- declared).
- •Subject who has participated in a similar clinical investigation in the past one month.
结局指标
主要结局
1. Improvement in skin firmness or elasticity in comparison to baseline at different timepoints.
时间窗: Baseline, 72hours, week 2 and week 4
2. Improvement in Wrinkles, Fine lines and Post Inflammatory Hyperpigmentation (Dark Spots) in comparison to Baseline at different timepoints.
时间窗: Baseline, 72hours, week 2 and week 4
3. Improvement in hydration in comparison to untreated site and Baseline at different timepoints
时间窗: Baseline, 72hours, week 2 and week 4
4. Improvement in the skin color in comparison to baseline at different timepoints.
时间窗: Baseline, 72hours, week 2 and week 4
次要结局
- 1. To evaluate dermatological safety and tolerability of the test product for the entire study duration
研究者
Dr Mukesh Ramnane
MS Clinical Research Pvt Ltd