Clinical Evaluation of efficacy and safety of Lip Balm in mild to moderate lip dryness
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in dryness of lips
研究概览
简要总结
It is a clinical study to evaluate efficacy and safety of Lip Balm in mild to moderate lip dryness. The study will be carried out at one center in India. Subjects will be asked to apply Emami Lip balm twice daily (morning after bath and before going to bed) for a period of 30 days. Primary objective will be to assess change in dryness of lips. The secondary objectives of the study will be to assess change in lips fine lines, hydration, colour, global assessment of overall change in lip dryness, skin patch test using Dermal Response Score, and safety by observing episodes, severity and duration of any allergic reactions and adverse events
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
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects suffering from mild to moderate dryness of lips.
排除标准
- •History of lip injections or lip surgery, chronically dry or chapped lip
- •History of recent or ongoing use of medication that can have dryness as a side effect.
- •Subject with severe dermatological disorders that might interfere with the study evaluation
- •Known cases of any Hypersensitivity to Lip balm ingredients
- •Subjects who have participated in any other clinical study since last 3 months
- •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
Change in dryness of lips
时间窗: Baseline visit (day 0), day 15 and end of study visit (Day 30)
次要结局
- 1. Change in lips fine lines, hydration, colour(2. Global assessment of overall change in lip dryness)
研究者
Dr Amruta Bhagwan More
Target Institute of Medical Education and Research Pvt Ltd.