Evaluation of Efficacy and Safety of Namaskar Ayurved Restore and Refresh Vetiver Concentrate in Healthy participants for its skin soothing and hydration activities- An open label, non-comparative, interventional, prospective, clinical study
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in facial cutaneous moisturization
研究概览
简要总结
It is an open label, non-comparative, interventional, prospective, clinical study to evaluate efficacy and safety of Namaskar Ayurved Restore and Refresh Vetiver Concentrate in healthy participants for its skin soothing and hydration activities. Subjects will be asked to apply Namaskar Ayurved Restore and Refresh Vetiver Concentrate on face twice in a day for a period of 7 days. The primary objective of the study will be to assess change in facial cutaneous moisturization. Secondary objectives of the study will be to assess changes in overall skin (facial) texture/roughness (Tactile), & (Visual), overall facial skin luminosity/radiance, assessment of 24 hr skin patch test, changes in freshness of the facial skin, facial hyperpigmentation/ dark spot, facial scar, blemishes on facial skin, assessment of mood, global assessment for overall change, post treatment tolerability of study drug and adverse events on screening / baseline visit, visit 1 (24 hrs. post skin patch test application), visit 2 (48 hrs. post skin patch test application, visit 3 (Day 3), visit 4 (Day 7)
Results and Conclusion:
Namaskar Ayurved Restore and Refresh Vetiver Concentrate was significantly effective in improving facial cutaneous moisturization, skin (facial) texture /roughness (Tactile and visual), facial skin luminosity, freshness of the facial skin, reduction of facial hyperpigmentation/dark spots, facial scars, blemishes on facial skin, and improvement of overall mood. Namaskar Ayurved Restore and Refresh Vetiver Concentrate was found to be safe for regular use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy Male and female subjects 2.Willing to comply with all requirements of the study.
排除标准
- •1.Subjects with a known current history of chronic skin diseases or autoimmune diseases, such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo and rosacea 2.Subjects with a tattoo, a scar, moles, too many hairs or anything on the Right leg which might interfere with the evaluation.
- •3.Subjects with intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.
- •4.Subjects who have used facial skin hydrating and soothing products (topicals), moisturizing cream, lotion or oil within 21 days before entering the trial 5.Subjects on any other investigational products within 1 month prior to randomization 6.Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer, kidney failure, liver failure 7.Pregnant and lactating women 8.Known hypersensitivity to any of the ingredients of Namaskar Ayurved Restore and Refresh Vetiver Concentrate 9.Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study.
结局指标
主要结局
Changes in facial cutaneous moisturization
时间窗: Day 0, 24 hrs. post skin patch test application, 48 hrs. post skin patch test application, Day 3, Day 7
次要结局
- 1. Changes in overall skin (facial) texture/roughness (Tactile)(2. Changes in overall skin (facial) texture/roughness (Visual))