Virus Clinical Trial
Official title:
Herpes Simplex Virus-1: A Pilot Study Using Hand Sanitizer
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | November 30, 2023 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: 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. Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
United States | Idaho State University | Pocatello | Idaho |
United States | Cotton Creek Dental | Saint George | Utah |
United States | Utah Tech University | Saint George | Utah |
Lead Sponsor | Collaborator |
---|---|
Leciel Bono |
United States,
Angewandte V. As a biocidal active substance, ethanol is indispensable for hygienic hand disinfection. Zentralsterilisation. 2020; 28(6):354-359. Our study has never been investigated by researchers. This is a pilot study exploring the effectiveness of ethyl alcohol on HSV-1 lesions. Therefore all research studies pertain to the virucidal effects of 70% ethyl alcohol.
Sauerbrei A. Bactericidal and virucidal activity of ethanol and povidone-iodine. Microbiologyopen. 2020 Sep;9(9):e1097. doi: 10.1002/mbo3.1097. Epub 2020 Jun 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of HSV-1 Lesion | 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. | 1-14 days | |
Secondary | Level of Pain during Treatment | 2. Is there a statistically significant difference in the level of pain during the treatment application process of an HSV-1 lesion for those who use Purell hand sanitizer on their lesion versus those who are in the control group using medical grade mineral oil? Pain will be measured by the participants daily using a Visual Analog Scale (VAS) which ranges from 1-10 with 1=no pain and 10=extreme pain. The higher the score in the VAS scale, the more pain the participant is experiencing. The pain scale will be used after the medication is applied to determine if there is any corresponding pain with the medication. | 1-14 days | |
Secondary | Level of Discomfort during Treatment | Is there a statistically significant difference in the level of discomfort during an HSV-1 lesion for those who use Purell hand sanitizer on their lesion versus those who are in the control group using medical grade mineral oil? Level of discomfort will be measured by the participants daily using a Visual Analog Scale (VAS) which ranges from 1-10 with 1=no pain and 10=extreme pain. The higher the score the VAS scale, the higher the level of discomfort with the HSV-1 lesion. The level of discomfort refers to the overall discomfort from the lesion experienced by participants on that day. | 1-14 days | |
Secondary | Size of Lesion during Treatment | Is there a statistically significant difference in the size of the HSV-1 lesion for those who use Purell hand sanitizer on their lesion versus those who are in the control group using medical grade mineral oil? The size of the lesion will be measured daily by the participant using millimeter markings on a laminated ruler provided in the kit. Participants will be given instructions on how to measure the lesion using this ruler. | 1-14 days |
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