Hand Sanitizer Use for Herpes Simplex Virus-1

NCT ID: NCT06135844

Last Updated: 2023-11-18

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-08

Study Completion Date

2023-11-30

Brief Summary

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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

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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.

Conditions

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Virus HSV-1 Herpes Simplex 1 Herpes Simplex Labialis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Purell Hand Sanitizer

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Medical Grade Mineral Oil

Intervention Type DRUG

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%

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Hand Sanitizer Mineral Oil

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Leciel Bono

OTHER

Sponsor Role lead

Responsible Party

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Leciel Bono

Associate Professor, Graduate Program Director/Interim Dept. Chair

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status RECRUITING

Cotton Creek Dental

St. George, Utah, United States

Site Status RECRUITING

Utah Tech University

St. George, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Leciel Bono, MS

Role: CONTACT

2082823076

Amanda Gibbs, MS candidate

Role: CONTACT

(801)450-3509

Facility Contacts

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Leciel Bono, MS

Role: primary

208-242-8158

Amanda Gibbs, MS candidate

Role: primary

801-450-3509

Brenda Armstrong, MS

Role: primary

435-879-4909

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 32567807 (View on PubMed)

Related Links

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http://apps.who.int/iris/bitstream/handle/10665/44102/9789241597906_eng.pdf

World Health Organization. Guideline on Hand Hygiene in Healthcare. 2009.

http://www.fda.gov/consumers/if-soap-and-water-are-not-available-hand-sanitizers-may-be-good-alternative

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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