Herpes Simplex Virus-1: A Pilot Study Using Hand Sanitizer
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Duration of HSV-1 Lesion
研究概览
简要总结
The purpose of this pilot study is to determine if the use of Purell hand sanitizer alters the duration, level of pain and discomfort during treatment, and the size of the HSV-1 lesion. The duration of an HSV-1 (herpes) lesion is the primary endpoint for this study. Size, pain, and discomfort are the secondary endpoints.
详细描述
The participants will be divided into a control group (10 participants) and treatment group (10 participants) and will be given either the Purell hand sanitizer (treatment group) or medical grade mineral oil (control group) to treat the lesion. Participants will apply a large drop of the product (purell hand sanitizer or mineral oil) on a q-tip and will hold the q-tip on the lesion for 10 seconds. Participants will be instructed to apply a solution to lesion every waking hour for the next 14 days or until lesion has healed. Each day the participant will fill out the daily journal. The journal includes a measurement in millimeters of the lesion with graph paper, recorded number of applications for that day, and two visual analog scales- one measuring any discomfort from the lesion and the other recording the pain during the application process.
Documentation of changes to the lesion will be recorded in a daily journal until the lesion is healed. There are two days that the participants are expected to return to the clinic for re-examination at day three and the last day when the lesion has healed, or the crust has fallen off. Pictures of the lesion will taken at these two points in time.
The duration the HSV-1 lesion, level of pain and discomfort during treatment, and the size of the HSV-1 lesion will be statistically measured between the control group (mineral oil) and the treatment group (purell hand sanitizer) to determine if there is any statistical difference between the two groups.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For the purpose of this study participants must be:
- •in the early prodromal stage of an HSV-1 outbreak (less than 24 hours from initial symptom)
- •have a visible manifestation of a lesion
- •be 18 years or older
- •capable of following daily treatment instructions
- •willing to complete a daily journal
- •willing to come to the clinic twice for records and pictures during the14 days that the lesion is present or until participant is free of lesion.
排除标准
- •For the purpose of this study participants cannot:
- •be immunocompromised
- •be pregnant
- •have taken any antiviral medication within the last two weeks
- •have used any creams in the last ten days.
研究组 & 干预措施
Treatment Group (Hand Sanitizer)
Participants with an early prodromal stage of an HSV-1 outbreak (less than 24 hours from initial symptom), with the visible manifestation of a lesion will be invited to participate in the study. Participants will apply a large drop of hand sanitizer in an unmarked container to a Q-tip and will hold the Q-tip on the lesion for 10 seconds. The hand sanitizer will be administered every waking hour in the same manner.
干预措施: Purell Hand Sanitizer (Drug)
Control Group (Medical Grade Mineral Oil)
Participants with an early prodromal stage of an HSV-1 outbreak (less than 24 hours from initial symptom), with the visible manifestation of a lesion will be invited to participate in the study. Participants will apply a large drop of Medical Grade Mineral Oil in an unmarked container to a Q-tip and will hold the Q-tip on the HSV-1 lesion for 10 seconds. The medical grade mineral oil will be administered every waking hour in the same manner.
干预措施: Medical Grade Mineral Oil (Drug)
结局指标
主要结局
Duration of HSV-1 Lesion
时间窗: 1-14 days
1. Is there a statistically significant difference in the duration of the HSV-1 lesion in individuals who use Purell hand sanitizer on their lesion versus those who are in the control group using medical grade mineral oil? The duration will be determined when the crust of the lesion has fallen off and the lesion is fully healed. Once healed, the participant will be required to return to the clinic for a concluding photograph taken by the research assistant and return the daily journal.
次要结局
- Size of Lesion during Treatment(1-14 days)
- Level of Discomfort during Treatment(1-14 days)
- Level of Pain during Treatment(1-14 days)
研究者
Leciel Bono
Associate Professor, Graduate Program Director/Interim Dept. Chair
Idaho State University