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VirusEarly Phase 1NCT06135844

Hand Sanitizer Use for Herpes Simplex Virus-1

A Early Phase 1 study testing Purell Hand Sanitizer and Medical Grade Mineral Oil in people with Virus and HSV-1, run by Leciel Bono at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Virus, HSV-1, Herpes Simplex 1
What is being tested?
Purell Hand Sanitizer and Medical Grade Mineral Oil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
3 sitesUnited States
Study dates
8 Apr 2022to 30 Nov 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

Leciel Bono, MS contact

2082823076

bonoleci@isu.edu

Amanda Gibbs, MS candidate contact

(801)450-3509

amandagibbs@isu.edu

United States3 sites, 3 recruiting

  • Idaho State University

    Pocatello, Idaho, 83209

    Leciel Bono, MS, 208-242-8158, bonoleci@isu.edu

    Recruiting

  • Cotton Creek Dental

    St. George, Utah, 84780

    Amanda Gibbs, MS candidate, 801-450-3509, amandagibbs@isu.edu

    Recruiting

  • Utah Tech University

    St. George, Utah, 84790

    Brenda Armstrong, MS, 435-879-4909, Brenda.Armstrong@utahtech.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Purell Hand Sanitizer, Medical Grade Mineral Oil
Keywords
Virus, HSV-1, Herpes Simplex 1, Herpes Simplex Labialis
Medical subject headings
Virus Diseases, Herpes Labialis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Purell Hand SanitizerDrug

    Also called Hand Sanitizer

    Active ingredient. Ethyl alcohol 70%

  • Medical Grade Mineral OilDrug

    Also called Mineral Oil

    Inert ingredients: Saturated hydrocarbons, with a purity and chemical structure that differs substantially from food-grade or technical-/industrial-grade mineral oils.

Study groups in NCT06135844
Study groupRoleWhat they receive
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.
Receives: Drug: Purell Hand Sanitizer
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.
Receives: Drug: Medical Grade Mineral Oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1-14 days

Secondary outcomes (3)

  1. Level of Pain during Treatment

    1. 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.

    Measured: 1-14 days

  2. 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.

    Measured: 1-14 days

  3. 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.

    Measured: 1-14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start8 Apr 2022
  3. Primary completion30 Nov 2023 (estimated)
  4. Study completion30 Nov 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06135844
Sponsor's protocol ID
IRB-FY2022-172
Status last verified
Nov 2023
First submitted
30 Oct 2023
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32567807

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Purell Hand Sanitizer and Medical Grade Mineral Oil in people with Virus and HSV-1, run by Leciel Bono at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Leciel Bono, MS (2082823076, bonoleci@isu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of HSV-1 Lesion (time frame: 1-14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06135844, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

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