Hand Sanitizer Use for Herpes Simplex Virus-1
Herpes Simplex Virus-1: A Pilot Study Using Hand Sanitizer
1 other identifier
interventional
20
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Apr 2022
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 8, 2022
CompletedFirst Submitted
Initial submission to the registry
October 30, 2023
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedNovember 18, 2023
November 1, 2023
1.6 years
October 30, 2023
November 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Level of Pain during Treatment
1-14 days
Level of Discomfort during Treatment
1-14 days
Size of Lesion during Treatment
1-14 days
Study Arms (2)
Treatment Group (Hand Sanitizer)
EXPERIMENTALParticipants 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.
Control Group (Medical Grade Mineral Oil)
PLACEBO COMPARATORParticipants 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.
Interventions
Active ingredient. Ethyl alcohol 70%
Inert ingredients: Saturated hydrocarbons, with a purity and chemical structure that differs substantially from food-grade or technical-/industrial-grade mineral oils.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Leciel Bonolead
Study Sites (3)
Idaho State University
Pocatello, Idaho, 83209, United States
Cotton Creek Dental
St. George, Utah, 84780, United States
Utah Tech University
St. George, Utah, 84790, United States
Related Publications (2)
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.
BACKGROUNDSauerbrei 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.
PMID: 32567807BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Leciel Bono, MS
Idaho State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor, Graduate Program Director/Interim Dept. Chair
Study Record Dates
First Submitted
October 30, 2023
First Posted
November 18, 2023
Study Start
April 8, 2022
Primary Completion
November 30, 2023
Study Completion
November 30, 2023
Last Updated
November 18, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share