Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
20 participants
INTERVENTIONAL
2022-04-08
2023-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Purell Hand Sanitizer
Active ingredient. Ethyl alcohol 70%
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.
Medical Grade Mineral Oil
Inert ingredients: Saturated hydrocarbons, with a purity and chemical structure that differs substantially from food-grade or technical-/industrial-grade mineral oils.
Interventions
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Purell Hand Sanitizer
Active ingredient. Ethyl alcohol 70%
Medical Grade Mineral Oil
Inert ingredients: Saturated hydrocarbons, with a purity and chemical structure that differs substantially from food-grade or technical-/industrial-grade mineral oils.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* be immunocompromised
* be pregnant
* have taken any antiviral medication within the last two weeks
* have used any creams in the last ten days.
18 Years
99 Years
ALL
Yes
Sponsors
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Leciel Bono
OTHER
Responsible Party
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Leciel Bono
Associate Professor, Graduate Program Director/Interim Dept. Chair
Principal Investigators
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Leciel Bono, MS
Role: STUDY_CHAIR
Idaho State University
Locations
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Idaho State University
Pocatello, Idaho, United States
Cotton Creek Dental
St. George, Utah, United States
Utah Tech University
St. George, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Related Links
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World Health Organization. Guideline on Hand Hygiene in Healthcare. 2009.
U.S. Food and Drug Administration (2019, April 11). If soap and water are not available, hand sanitizers may be a good alternative.
Other Identifiers
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IRB-FY2022-172
Identifier Type: -
Identifier Source: org_study_id
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