An open-label single-arm interventional clinical trial to evaluate the anti-aging efficacy and safety of topical application of Aswagandha moisturizing cream among healthy volunteers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- • To evaluate the efficacy of the Ashwagandha moisturizing cream in reducing the appearance of fine lines and wrinkles.
研究概览
简要总结
This open-label, single-arm interventional clinical trial aims to evaluate the anti-aging efficacy and safety of a topical Ashwagandha moisturizing cream in reducing the appearance of fine lines and wrinkles among healthy volunteers. Thirty participants will apply the Ashwagandha cream daily over a 16-week period, with assessments conducted at baseline (Week 0), and at Weeks 4, 8, 12, and 16. The primary objective of the study is to assess the cream’s efficacy in reducing wrinkle appearance and fine lines, with secondary objectives including evaluation of tolerability, safety, and overall improvement in skin health as reported by participants.
Clinical wrinkle assessment will be conducted using Standard Wrinkle Scales, focusing on specific facial areas: the Crow’s Feet Wrinkle Scale (CFWS) for the lateral eye area, Forehead Wrinkle Severity Scale (FWSS) for forehead lines, Nasolabial Fold Wrinkle Scale (NLFS) for nasolabial wrinkles, and Global Fine Line Scale (GFLS) for general fine lines. High-resolution digital imaging will be used to objectively record and measure wrinkle depth and fine line counts. Participants will also complete a Self-Assessment Questionnaire evaluating various skin parameters, including hydration, moisture retention, wrinkle reduction, elasticity, firmness, texture, radiance, and overall satisfaction. A Global Tolerability Assessment will be conducted at each visit to monitor safety and participant comfort.
This study is designed to provide insights into the efficacy and tolerability of Ashwagandha moisturizing cream as a topical anti-aging solution, with clinical and subjective measures used to assess its potential in enhancing skin health and appearance.
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
- 25.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects willing to provide signed informed consent prior to the study.
- •Healthy male or female participants aged between 25 and 55 years.
- •Subjects with visible signs of mild to moderate skin aging (e.g., fine lines, wrinkles, dryness).
- •Subjects who committed not to use any other cosmetics during the entire duration of the study.
- •Participants willing to comply with the study protocol and follow-up requirements.
- •Fitzpatrick skin types I–IV.
排除标准
- •Subjects with a history of significant dermatological conditions (e.g., eczema, psoriasis) or skin diseases that may interfere with the assessment.
- •History of systemic or cutaneous malignancy or with nevi or cutaneous lesions currently.
- •Patients with known hypersensitivity to ingredients of the trial drug.
- •Patients with history of facial surgery, cosmetic procedures.
- •Participants in any another clinical trial within 30 days prior to the study.
- •Participants in use of any other antiaging skincare treatments within 4 weeks prior to enrollment.
结局指标
主要结局
• To evaluate the efficacy of the Ashwagandha moisturizing cream in reducing the appearance of fine lines and wrinkles.
时间窗: Anti-aging effect will be assessed on Visit 1(Week 0), Visit 2(Week 4), Visit 3(Week 8), Visit 4(Week 12) and on the day of follow up Visit (Week 16)â€
次要结局
- • To evaluate the tolerability and safety profile of the Ashwagandha cream during the study period(Anti-aging effect will be assessed on Visit 1(Week 0), Visit 2(Week 4), Visit 3(Week 8), Visit 4(Week 12) and on the day of follow up Visit (Week 16)â€)
研究者
Dr J Hareendran Nair
Pankajakasthuri Herbal Research Foundation