Research ArticleResearch

Herpes Simplex Virus-1 and Hand Sanitizer: A pilot study

Amanda L. Gibbs, Leciel K. Bono and JoAnn R. Gurenlian
American Dental Hygienists' Association August 2024, 98 (4) 28-36;

Abstract

Purpose Herpes Simplex Virus type 1 (HSV-1) is a highly contagious virus that manifests as a painful lesion and recurrences can be distressing to patients. The purpose of this pilot study was to determine if the use of a 70% ethanol alcohol hand sanitizer alters the duration, size of the lesion, level of pain upon administering treatment, and overall daily discomfort during outbreak.

Methods This study was a double-blind randomized controlled trial (RCT) using 70% ethanol alcohol hand sanitizer for the experiment and medical grade mineral oil for the control group. The treatment and the control were dispensed in lip gloss applicators for applying medicament. Data was collected through the initial examination, a daily journal, photographs, and a reexamination day. Descriptive statistics and the independent sample t-test were used to analyze data (p=0.05).

Results A total of 20 individuals completed the research study: ten in the experimental group and ten in the control group. The mean duration of HSV-1 lesions for the control group was 10.3 days while the mean duration of the HSV-1 lesions for the experimental group was 7.6 days. The mean size of lesions for the control group was 4.87 mm; the mean size for the experimental group was 4.25 mm. The mean pain score for the control group was 1.08 and the mean pain score for the experimental group was 2.74. The mean discomfort score for the control group was 1.33 while the mean discomfort score for the experimental group was 1.72. There was no statistically significant difference between the experimental and control groups in terms of duration, size of lesions, pain, and discomfort.

Conclusion Based on the results of this pilot study, 70% ethanol alcohol hand sanitizer did not demonstrate statistical significance in the treatment and management of HSV-1 lesions. Additional research is needed with a larger sample size to determine if statistical differences can be measured.

Keywords

INTRODUCTION

Herpes Simplex Virus-1 (HSV-1) is a highly contagious virus commonly known as a cold sore or a fever blister. An estimated 90% of adults in the United States have experienced an HSV-1 infection, while globally approximately 3.7 billion adults have HSV-1 infection.1,2 Many triggers can contribute to the formation of a HSV-1 lesion including injury or trauma to the lip, illness, sunlight, stress, and surgery.1 The HSV-1 can be spread by touching the infected area and self-inoculating or by spreading the virus to others through direct contact.3 The HSV-1 manifests as an orofacial lesion that begins as an erythematous base of papules, progresses to vesicles within hours of initial appearance (considered the most contagious stage), and then ends in ulcerated crusts.4 HSV-1 is also associated with epithelial and stromal keratitis, encephalitis, eczema herpeticum, and herpetic whitlow and can also have detrimental effects on immunocompromised individuals.5-8

Herpes simplex virus-1 is an enveloped, double-stranded DNA virus belonging to the Herpesviridae family and is considered to be a large virus (150-200nm diameter).6-9 Multiple stages occur during the HSV-1 infection process beginning with viral entry, viral gene expression, viral DNA synthesis, and reproduction of infected host cells or assembly of progeny virion.10 The HSV-1 establishes a latent infection in the host, often lasting a lifetime. Many viral infections constantly replicate; however, during HSV-1’s latent stage, no viral progeny (or very little) is produced.10 The latency site is located in the sensory neurons of ganglion tissue.10,11 These characteristics are important for determining treatment options for HSV-1; for example, enveloped viruses are more susceptible to desiccation, heat, and alcohols.12

Although HSV-1 is most contagious in the vesicle stage, further research has found asymptomatic shedding (HSV present without a lesion) leading to an increased transmission period.13,14 In a study by Ramchandani et al.,13 eight immunocompetent participants with a history of symptomatic HSV-1 lesions underwent examinations five times a week for five weeks. During these examinations, samples were taken from 12 different orofacial sites (left nares, right nares, pharynx, tongue, left palate, right palate, left upper lip, right upper lip, left lower lip, right lower lip, and both conjunctiva). With 2,626 swabs collected (about 334 swabs per person), asymptomatic shedding was found on 27.1% of the days. Symptomatic shedding (HSV-1 lesion present) occurred on four of eleven days or 36.4%.13 With the transmission rate at its highest when the HSV-1 lesion is present, it is critical to identify a treatment that will decrease the duration of the outbreak.

Treating HSV-1 has been challenging and currently, no cure is available. Drug resistant variants of HSV-1 have been reported in the literature.14,15 Treatments for HSV-1 lesions include oral antiviral medication, topical creams gels, or a patch that adheres to the lesion, photodynamic therapy, amino acid, local anesthetic, or laser therapy.16-19 Some treatments are available over the counter; others require a prescription or are provided in-office.

There are several variables to consider when determining the best treatment route for HSV-1 lesions, such as whether the lesion is primary or recurrent, the patient’s preference, or whether the patient is immunocompromised.20 Primary HSV-1 lesions are most commonly treated with oral antiviral medications, whereas recurrent HSV-1 lesions are treated with topical antivirals in conjunction with oral antivirals.20-22 The HSV-1 recurrent infection is usually mild, but the outbreak can be uncomfortable and disfiguring, leaving a psychological impact that should not be underestimated, especially among young patients with multiple recurrences.23

Evidence-based research examining treatments for HSV-1 has yielded varied results. Boes et al.16 compared three products (acyclovir cream 5%, acyclovir 5% patch, and a denatured alcohol and zinc serum) with healing time, reaction rate, and reaction quality on 180 participants. The denatured alcohol-zinc serum demonstrated the highest measurements for all three of these features; however, this serum also showed the most intolerances, such as dried lips and redness.16

An oral medication (valacyclovir) with a topical steroid (clobetasol propionate) has been compared to an oral and topical placebo.21 This study demonstrated that aborted lesions significantly increased while classical lesion size and healing time significantly decreased. These results suggested that the combination of valacyclovir and clobetasol propionate is safe and effective for HSV-1 lesions supporting the theory that corticosteroids can be used as a treatment for HSV-1 lesions; however, further research is warranted to establish the efficacy of corticosteroids as a treatment option.21

A recent study established an inactivation effect on enveloped viruses (such as the HSV-1) occurred when ethanol alcohol was used at 60%-80%. When used as a hand disinfectant, this compound has microbial effects against enveloped and non-enveloped viruses.24 Ethanol alcohol was tested for toxicity levels as it is absorbed through the skin and inhalation of the fumes to determine the safety of its use.25 and the findings demonstrated the safety and efficacy of ethanol alcohol when used as a virucidal agent.25 These results raise the question of whether ethanol alcohol could have a virucidal effect on an HSV-1 lesion.

Identifying a treatment to minimize the highly contagious stage would help reduce the spread of the virus. One possible option is the use of 70% ethanol alcohol hand sanitizer, a popular disinfectant known for its powerful virucidal and bactericidal effects.26 Ethanol alcohol, the main ingredient in hand sanitizer, in concentrations of 60%-80% has been shown to kill the HSV-1 virus.26 More research is needed to determine the efficacy of using 70% ethanol alcohol hand sanitizer as an HSV-1 treatment option. Thus, the purpose of this pilot study was to evaluate the efficacy of 70% ethanol alcohol on HSV-1 lesions in reducing the duration, size, pain, and discomfort as compared to a control. The following research question guided the study: Is there a statistically significant difference in the duration, size of the lesion, level of pain, and level of discomfort for individuals in the experimental group who used 70% ethanol alcohol hand sanitizer on their lesion versus those in the control group who used a medical grade mineral oil?

METHODS

Study Design

This double-blind randomized controlled study was approved by the Idaho State University Institutional Review Board (IRB-FY2022-172) and was registered in ClinicalTrials.gov (NCT06135844). A total of 20 kits were created, one for each participant. Ten lip balm applicators were filled with 70% ethanol alcohol hand sanitizer (experimental group) and the other ten lip balm applicators were filled with medical grade mineral oil (control group). The medical grade mineral oil served as a negative control. The lip balm applicators provided a “touch-free” application, limiting self-inoculation and spreading. The applicators were free from any labeling except a single letter “A” (70% ethanol alcohol hand sanitizer), or “R” (medical grade mineral oil) located on the lid to ensure blinding. Each lip balm was placed in a paper sack along with paper laminated millimeter ruler and a packet including daily instructions, a space for a daily journal, and provided a place to put the assigned letter (R or A).

Sample

Study participants consisted of a convenience sample of local community members near dental hygiene clinics in St. George, Utah; Pocatello, Idaho; and Long Beach, California. Recruitment for participants was achieved using social media and flyers posted at each clinical program site. Recruitment for the study occurred every two weeks until 20 eligible participants were recruited. The study was conducted between October 2022 to September 2023.

For the purpose of this study participants needed to be in the early prodromal stage of an HSV-1 recurrent herpes labialis (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, willing to come to the assigned clinic for the initial examination and final examination. Exclusion criteria included individuals who were immunocompromised, pregnant, taking any antiviral medication within the last two weeks, and using any antiviral creams in the last 10 days.

Research Assistant Training

Four dental hygienists and one nurse comprised the research assistants for this study. Each completed the Collaborative Institutional Training Initiative certification program followed by a standardization course led by the primary investigator via a virtual meeting platform (Zoom; San Jose, CA, USA). The research assistants were provided instructions on the data collection procedure, guidelines for preparing participants to use the kits were discussed and all questions were clarified. The research assistants were a key component in keeping the primary investigator and co-investigators blinded. Once trained, research assistants were sent multiple experimental and controlled group kits.

Study Protocol and Procedures

To be approved for the study, potential participants must have been in the early prodromal stage of HSV-1 defined as less than 24 hours from initial symptom. Participants self-reported this symptom to the research assistant at the clinical site. Upon approval for eligibility, participants received and signed the informed consent form, and the study instructions were completed. Participants were able to begin the treatment as soon as they were approved by the research assistants.

The research assistants randomly assigned the participants to either the experimental or control group by drawing a study kit out of the box mailed to them by the primary investigator. For experimental group participants, the research assistants were instructed to administer a fresh container of 70% ethanol alcohol into the lip balm applicator prior to their arrival. Participant names, contact information, age, gender, and an initial photo of the lesion were collected on the first day. The written instructions on how to use the product, journal for recording the data, how to measure the lesion, and record pain were explained verbally. Each day the participants were to record the lesion size, number of daily applications, pain, discomfort, and any additional notes regarding the lesion or the process in their daily journal (Figure 1). The lesion duration was determined when the crust had fallen off and the lesion was fully healed with the lip mucosa presenting normal appearance. Once healed, the participant returned to the clinic for a concluding photograph taken by the research assistant and to return the daily journal. The lesion size was to be measured daily by the participant using millimeter markings on a laminated ruler provided in the kit. Participants were given instructions on how to measure the lesion by holding the ruler under the lesion and measuring the lesion in millimeters. Participants were asked to demonstrate this measurement on the initial examination. Pain and discomfort were measured by the participants once daily using a Visual Analog Scale (VAS). The discomfort scale referred to their overall discomfort from the lesion that day, whereas the pain scale referred to the overall pain associated with applying the 70% ethanol alcohol hand sanitizer or mineral oil.

Figure 1.
Figure 1.

Daily journal sample with Visual Analog Scale

The VAS measurements began with zero meaning no discomfort or pain and ended with ten meaning worst discomfort or pain. The VAS has been widely used to record patient’s pain progression and for diverse types of conditions including pain, cancer, and ambulation.27-29 This scale was completed by participants who marked on the line the point they felt best represented their perception of their current state. The VAS takes less than one minute to complete and is easy to use with minimal training. Values of reliability have been shown to be between r=0.94-0.99.27,28 For construct validity, correlations range from 0.71-0.78 and 0.62-0.91.30

Instructions for the lip balm application were to apply one drop to the lesion and hold it there with the tube for 20 seconds every hour (waking hours) for the first 4 days (about 12 applications a day) or until the lesion is gone. Each lip balm applicator held a sufficient amount of solution for participants to complete the study. Participants were instructed to continue the journal and discomfort measurements until the lesion was healed (crust free and intact mucosa). Once the lesion was healed, participants were instructed to contact the research assistant for a final examination and photo. At the end of the trial, all photos and documents were charted, analyzed, and compared. The primary endpoint for this study was the duration of a HSV-1 lesion. The secondary endpoint was a measurement for size, pain, and discomfort.

Descriptive statistics and the independent sample t-test were used to analyze data from the two groups. Significance was set at p=0.05. The consolidation standards for reporting trials an extension to pilot or feasibility trials (CONSORT) checklist was used as a guide for designing and reporting the results of the study.31

RESULTS

A total of 20 individuals completed the study: ten in the experimental group and ten in the control group. One participant in the control group did not report pain level data; all other data were reported correctly and were included in the final analysis. No adverse events were reported. Most participants were female (80%, n=16); 4 (20%) were male. Participants ranged from 20-69 years with an average age of 40.80 years. The majority (45%, n=9) were from Utah, 8 (40%) were from Idaho, and 3 (15%) were from California.

Photographs were used to document the initial presentation of the HSV-1 lesion and the resolution of the lesion for each study participant. Figure 2 represents the photos taken for an experimental group participant. Photos for a control group participant are shown in Figure 3. The mean duration of HSV-1 lesions for the control group was 10.3 days while the duration range was 2 to 24 days. The mean duration of the HSV-1 lesions for the experimental group was 7.6 days with the range of duration from 2-13 days. The independent sample t-test was 1.12, p-value=0.28.

Figure 2.
Figure 2.

Initial and final photos of an experimental group participant

Figure 3.
Figure 3.

Initial and final photos of a control group participant

Size of the HSV-1 lesions were measured by millimeters. The range lesion size for the control group was 2 to 8.57 mm and the mean size was 4.87 mm. The range of lesion size for the experimental group was 0.5-10.45 mm and the mean size was 4.25 mm. The independent sample t-test was 0.48; p-value =0.63.

Pain was measured using the Visual Analog Scale (VAS) upon administration of the medicament. The mean pain score for the control group was 1.08 and the range was 0-4.25. The mean pain score for the experimental group was 2.74 and the range was 0.5-6.5. The independent sample t-test was 1.89; p-value = 0.77.

Discomfort of the lesion was measured using the VAS on a daily basis until the lesion was healed. The range of discomfort for the control group was 0.5-2.09 and the mean was 1.33. The range of discomfort for the experimental group was 0-3.77 while the mean was 1.72. The independent sample t-test was 0.89; p-value =0.38.

There was no statistically significant difference between the use of 70% ethanol alcohol hand sanitizer and the medical grade mineral oil in terms of HSV-1 lesion duration, size, pain, and discomfort. These findings are shown in Table I.

View this table:
Table I.

Summary of HSV-1 lesion findings (n=20)

DISCUSSION

The findings of this study revealed three key factors. First, one purpose of a pilot study is to evaluate the feasibility of the protocol and procedures.31 This study demonstrated that the protocol was appropriate and manageable. Participants were compliant with the application of the products and recorded duration, size, pain, and discomfort using the daily journal. There appeared to be no issues with following the instructions provided, even though the study lasted over two weeks and as long as 20 to 24 days for some participants. The protocol appeared safe, and no harm to the participants was apparent throughout the study.

The second factor was the sample size. Because the sample size for the pilot study was small, no statistical significance was noted for any of the variables studied: duration, size, pain, and discomfort. While this result was anticipated, replication of the study with a larger sample size might reveal different findings. Other studies used sample sizes ranging from 70 to over 300 participants, which would likely provide the basis for statistical comparison.16,21,22,32,33 It is interesting to note that the experimental group showed a shorter healing time even with the small sample size. One possible explanation is the antimicrobial effect of the 70% ethanol alcohol hand sanitizer on the HSV-1 lesion.26

The third factor, pain measurement, was reportedly more pronounced in the experimental group, perhaps associated with the 70% ethanol alcohol content of the hand sanitizer applied to an ulcerative lesion.34 Although higher pain was expected due to the alcohol content in the experimental group, a disadvantage of using 70% ethanol alcohol hand sanitizer as a treatment option would be if the pain exceeded compliance. Of the ten participants in the experimental group, no one experienced severe pain to terminate the study or recorded severe pain on the VAS scale to be significantly different from the control group.

There are a limited number of studies utilizing an alcohol-based product as part of the study protocol reported in the literature. In comparison to this pilot study, Boes et al,16 utilized denatured alcohol and zinc in comparison to an antiviral cream and patch to evaluate HSV-1 healing time, reaction rate, and reaction quality. Symptoms and features of the HSV-1 lesions were also tested. Outcomes showed that the denatured alcohol and zinc product had favorable results in terms of reaction rate and quality, lesion protection, esthetics, and relief of discomfort; however, healing time was not statistically significant compared to the antiviral cream and patch. Results from the current pilot study also demonstrated favorable results in terms of duration; however, statistical significance was not achieved using the ethanol alcohol hand sanitizer. Additional studies are needed to further evaluate the efficacy of alcohol-based products on HSV-1.

The participants demonstrated a high level of compliance with the study protocol. Researchers have documented psychosocial behaviors that help with patient adherence when treatment protocols are recommended.35-38 Optimism and hope about treatment outcomes are key factors in guiding patient adherence because they lend themselves to motivation and the value of achieving health or treatment goals.35 Participant adherence in this study may have been influenced by the desire to shorten the duration of the HSV-1 lesion. Many viral lesions in this study were located on the vermillion border of the lip, thus highly visible. In addition, lesions of this type created discomfort for most participants. Psychological stress and a negative mood about the HSV-1 lesions may have also influenced adherence. A study investigating the relationship between perceived psychological stress, negative mood, and the recurrence of HSV-1 demonstrated that participants who had more frequent outbreaks of HSV-1 were more likely to experience these factors.37 The current pilot study did not investigate stress or mood with HSV-1 lesions. However, this cyclic pattern may have contributed to patient adherence to the protocol, as participants may have been motivated to find a solution to break the cycle.

The primary limitation of this study was the sample size, as results cannot be generalized to the population at large. In addition, the smaller sample size did not permit an evaluation of an estimated effect size, which could lead to a type II error. The smaller sample size was not sufficiently powered to detect a difference between the two groups. Future recommendations include replicating this study with a larger sample size to see if there is a statistical difference between groups and whether the results represent a true, false positive, or false negative result. Another recommendation would be to take photographs of the lesion every other day for a visual comparison of the size and duration of lesions.

CONCLUSION

Herpes simplex virus −1 is a common contagious infection affecting many individuals. Various treatment modalities are used in the management of HSV-1. A randomized controlled clinical trial was conducted as a pilot study to determine if 70% ethanol alcohol could be beneficial as a treatment modality. Parameter studies included duration, pain, discomfort, and size of the lesion. While participant compliance was high, the findings did not show statistical significance between the experimental and control groups. Future studies should include a larger sample size to determine if statistical differences between groups can be measured and if differences represent a true result.

ACKNOWLEDGMENTS

The authors wish to acknowledge Kaitlyn Liebert, RDH, MS, Camille Biorn, RDH, MS, Peggy Lelesi, RDH, MS, who served as the Research Assistants for this study as well as the individuals who served as study participants

Footnotes

  • NDHRA priority area, Client level: Oral health care (new therapies and prevention modalities).

  • DISCLOSURES

    The authors have no conflicts of interest to declare.

  • Received December 6, 2023.
  • Accepted March 28, 2024.

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Herpes Simplex Virus-1 and Hand Sanitizer: A pilot study
Amanda L. Gibbs, Leciel K. Bono, JoAnn R. Gurenlian
American Dental Hygienists' Association Aug 2024, 98 (4) 28-36;
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