Hand Sanitizer Use for Herpes Simplex Virus-1

Virus Clinical Trial

Official title:

Herpes Simplex Virus-1: A Pilot Study Using Hand Sanitizer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06135844
• Other study ID #: IRB-FY2022-172
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 8, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: November 2023
• Source: Idaho State University
• Contact: Leciel Bono, MS
• Phone: 2082823076
• Email: bonoleci[@]isu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Herpes Labialis
• Herpes Simplex
• Herpes Simplex 1
• Herpes Simplex Labialis
• HSV-1
• Virus

Intervention

Drug:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Leciel Bono

Country where clinical trial is conducted

United States, 

References & 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.

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

Outcome

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

External Links

•   U.S. Food and Drug Administration (2019, April 11). If soap and water are not available, hand sanitizers may be a good alternative.
•   World Health Organization. Guideline on Hand Hygiene in Healthcare. 2009.