NCT02582086Unknown不适用
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Topical Natural Health Product for the Treatment of Herpes Labialis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time to healing as assessed by the investigator
研究概览
简要总结
The aim of this study is to determine the safety and efficacy of a topical natural health product in comparison to placebo for the treatment of herpes labialis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female and male, in good health, 18 years of age or older,
- •With history of recurrent herpes labialis with at least twice a year during the past twenty-four months,
- •Agreeing not to take another treatment against cold sore, nor anti-inflammatory, antibiotics and steroids,
- •Cooperating in the study, able to be monitored at each visit, aware of the demands and duration of the controls, thus allowing perfect adherence to the established protocol,
- •Must be willing and able to participate and to provide written informed consent,
- •Female subjects of childbearing potential must have a negative pregnancy test at screening and agree to use a proper contraceptive method during the study.
排除标准
- •Volunteers who refuse to introduce the product to be tested in its routine,
- •With a history of hypersensitivity to the type of product to be tested (e.g., products that contain essential oil),
- •Who have a history of eczema, topical dermatitis, psoriasis or significant skin anomalies on the areas to be tested,
- •Who suffer from a serious illness or health problem or a critical or progressive disease,
- •Who have taken prescription or over the counter medication that could affect skin characteristics or could bias the study (i.e. antibiotics, antihistamines, anti-inflammatories...) within 7 days prior to study beginning,
- •Who have recently acquired or who currently have significant skin pigmentation, who frequent tanning salons or foresee exposure to the sun during the study,
- •Who abuse alcohol, drugs and/or tobacco,
- •Female subjects who are pregnant, breastfeeding or expecting to become pregnant during the study.
研究组 & 干预措施
BOR15001L7 Cream
Experimental
BOR15001L7 Cream with 5% 15019L0
干预措施: BOR15001L7 (Other)
Placebo Cream
Placebo Comparator
Placebo Cream
干预措施: Placebo (Other)
结局指标
主要结局
Time to healing as assessed by the investigator
时间窗: up to 10 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Clinical Trial on the Efficacy of a Combination Herbal Product, Biotropics' Nu Femme, on Menopausal Symptoms and Quality of Life in WomenMenopausal SymptomsNCT02269891KGK Science Inc.119
已完成
1 期
Safety and Efficacy of a Natural Health Product in Reducing Cholesterol and Triglyceride Levels.TriglyceridesLDL CholesterolNCT01028274Nordic Pharma, USA148
已完成
1 期
Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital WartsAnogenital WartsCondylomata AcuminataHuman Papillomavirus InfectionNCT01532102Anaconda Pharma24
尚未招募
不适用
Clinical Study of De-Stress & Happy Gut Powder for Stress and Indigestion in Adults.IndigestionStressDyspepsiaNCT06568965Herbolab India Pvt. Ltd.81
已完成
2 期
Efficacy Study of IZN-6D4 Gel for the Treatment of Diabetic Foot UlcersDiabetic Foot UlcerNCT01427569Izun Pharma Ltd82