Clinical trial NCT06135844: Hand Sanitizer Use for Herpes Simplex Virus-1
Official title: Herpes Simplex Virus-1: A Pilot Study Using Hand Sanitizer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Virus
HSV-1
Herpes Simplex 1
Herpes Simplex Labialis
Keywords: Virus
HSV-1
Herpes Simplex 1
Herpes Simplex Labialis
Lead sponsor: Idaho State University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be divided into two groups: Control Group (mineral oil) and the Treatment Group (hand sanitizer). Each group will be asked to apply the product to the HSV-1 lesion. Sample 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), with the visible manifestation of a lesion, 18 years or older, capable of following daily treatment instructions, willing to complete a daily journal and willing to come to either clinic twice for photos during the duration of the lesion (day 3 and when the lesion has healed or the crust has fallen off the lesion).
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of HSV-1 Lesion
timeFrame: 1-14 days
Secondary outcomes:
measure: Level of Pain during Treatment
timeFrame: 1-14 days
measure: Level of Discomfort during Treatment
timeFrame: 1-14 days
measure: Size of Lesion during Treatment
timeFrame: 1-14 days
Other outcomes:
Locations:
city: Pocatello
country: United States
facility: Idaho State University
state: Idaho
city: Saint George
country: United States
facility: Cotton Creek Dental
state: Utah
city: Saint George
country: United States
facility: Utah Tech University
state: Utah
Study officials:
affiliation: Idaho State University
name: Leciel Bono, MS
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.