Recruiting
Early Phase 1

Hand Sanitizer

Sponsor:

Leciel Bono

Code:

NCT06135844

Conditions

Virus

HSV-1

Herpes Simplex 1

Herpes Simplex Labialis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Purell Hand Sanitizer

Medical Grade Mineral Oil

Study Details

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.

Conditions

Virus

HSV-1

Herpes Simplex 1

Herpes Simplex Labialis

Study ID

NCT06135844

Start date

Apr 8, 2022

Status verified date

Nov, 2023

Completion date

Nov 30, 2023

Anticipated

Primary completion date

Nov 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: 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.

Interventions

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.

Primary outcome measure

  • Duration of HSV-1 Lesion [ Time Frame: 1-14 days ]

Central Contacts and Locations

Central contacts

Leciel Bono, MS

2082823076bonoleci@isu.edu

Amanda Gibbs, MS candidate

(801)450-3509amandagibbs@isu.edu

Locations

Idaho State University

Recruiting

Pocatello, Idaho, United States, 83209

Contacts

Leciel Bono, MS

208-242-8158bonoleci@isu.edu

Cotton Creek Dental

Recruiting

Saint George, Utah, United States, 84780

Contacts

Amanda Gibbs, MS candidate

801-450-3509amandagibbs@isu.edu

Utah Tech University

Recruiting

Saint George, Utah, United States, 84790

Contacts

Brenda Armstrong, MS

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

More Information

Sponsor

Leciel Bono

Last update posted

Nov 18, 2023

Last verified

Nov, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Leciel Bono on 2023-11-18.