Pilot Study of Efficacy of Nail Gel Containing Artemisia Abrotanum Extract and Glycerin in Finger Nail Surface Abnormality
试验速览
- 阶段
- 3 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Improvement overall nail surface abnormalities
研究概览
简要总结
Nail surface abnormalities is any conditions that affect the nail matrix or nail bed which cause nail plates grow defectively. Common nail surface abnormalities are pitting nails, longitudinal ridging, and transverse ridging/Beau's line. Aging nails usually have nail surface abnormalities as well.
Nail gels are artificial nails used widely for aesthetic purposes. Although, their cosmetic use is increasing with day by day, their usefulness in conditions such as nail biting, brittle nails, and ingrown toe nails has been reported. Moreover, a previous study reported the benefits of nail gels in terms of improving nail surface abnormalities like pitting nails, trachyonychia, and onychoschizia.
This study was conducted to evaluate the efficacy of nail gel containing Glycerin which has humectant effect and Artemisia Abrotanum extract which has anti-fungal/bacterial activities in finger nail surface abnormalities.
详细描述
Evaluation of nail surface abnormality can be done by using Visiometer® (bioengineering measurement) and dermoscope. Both techniques are non-invasive.
Artemisia Abrotanum extract has been used as ingredient in cosmetic products and its safety has been declared. Undesirable events from external using products containing this substance have never been reported yet. Nail gel product in this study has been approved as a cosmetic product by Food and Drug Administration of Thailand (Thai FDA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years old or above
- •Being diagnosed nail surface abnormalities stably more than 3 months
排除标准
- •Having severe or uncontrolled concomitant diseases
- •Having nail infection
- •History of manicure within the last 1 month
- •Use of Biotin or other nail modifying drugs within the previous 3 months
- •Pregnancy or lactation
研究组 & 干预措施
Nail gel
apply nail gel twice daily
干预措施: Nail gel (Drug)
结局指标
主要结局
Improvement overall nail surface abnormalities
时间窗: 2 weeks and 8 weeks
Number of nails of each participant with change/improvement nail surface using clinical assessment
次要结局
- Increase nail hydration(2 weeks, and 8 weeks)
- Improvement roughness of nail surface abnormalities(2 weeks, and 8 weeks)
- Patients's satisfaction(2 weeks and 8 weeks)