To Clinical Study Evaluate the Efficacy of the Test Products in Providing Anti- Ageing Benefits
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- • Improvement in hydration in comparison to Baseline and at different timepoints.
研究概览
简要总结
This monocentric, double-blinded, full-face, randomized study evaluates the efficacy and safety of an anti-aging product over a 9-week period with 4 visits. Initially, 120 subjects who meet the inclusion and exclusion criteria will provide informed consent and undergo randomization into four groups. A 7-day washout period follows enrollment during which subjects must avoid all anti-aging products.
Visit 1 (Screening): Post-enrollment, subjects return after 7 days for their baseline assessments.
Visit 2 (Baseline): Subjects acclimatize for 10 minutes in controlled conditions before undergoing sequential assessments including dermatological evaluations and various instrument measurements, followed by a self-assessment. Post-assessment, subjects receive the study product for twice-daily application.
Visits 3 and 4 (Weeks 4 and 8): Compliance is verified, and after acclimatization, the same sequence of assessments is repeated. Subjects are instructed to bring their test products and diaries to these visits for verification.
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
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female adult subjects in general good health as determined from general physical examination, dermatological assessment.
- •Subjects in the age group of 30 to 50 years (both ages inclusive).
- •Subjects having dull or uneven skin or any other pigmentation.
- •Subject presenting at least 2 well defined dark spots of PIH or Acne or Age spots on the face.
- •Subject identified for fine lines of score 4 and above and wrinkles of score 2 and above
- •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 or treatment or home remedy or except the provided product on their face during the study period other than the test product.
- •on face during the study period.
- •Subjects who agree not to expose to excessive direct sun light (sun exposure not more than half an hour daily and during that time use of umbrella to cover face).
- •Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow up.
排除标准
- •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 jewellery or anything else.
- •Subjects who are pregnant and lactating (Self- declared).
- •Subject who has participated in a similar clinical investigation in the past two weeks.
- •Subjects with skin allergy, history of atopic dermatitis or psoriasis.
结局指标
主要结局
• Improvement in hydration in comparison to Baseline and at different timepoints.
时间窗: Day -7 (washout), Day 0, Day 28, Day 56
• Improvement in skin barrier function in comparison to Baseline and at different timepoints.
时间窗: Day -7 (washout), Day 0, Day 28, Day 56
• Improvement in skin firmness/elasticity in comparison to Baseline and at different timepoints.
时间窗: Day -7 (washout), Day 0, Day 28, Day 56
• Improvement in Wrinkles, Fine lines and Dark Spots in comparison to Baseline and at different timepoints.
时间窗: Day -7 (washout), Day 0, Day 28, Day 56
次要结局
- To evaluate dermatological safety and tolerability of the test product for the entire study duration.(Day -7 (washout), Day 0, Day 28, Day 56)
研究者
Dr Mukesh Ramnane
MS Clinical Research