Herpes Simplex 1, Herpes Simplex Labialis, HSV-1, Virus
Conditions
Keywords
Virus, HSV-1, Herpes Simplex 1, Herpes Simplex Labialis
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.
Interventions
DRUGPurell Hand Sanitizer
Active ingredient. Ethyl alcohol 70%
DRUGMedical 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.
Sponsors
Leciel Bono
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of HSV-1 Lesion | 1-14 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Pain during Treatment | 1-14 days | 2\. 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. |
| Level of Discomfort during Treatment | 1-14 days | 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. |
| Size of Lesion during Treatment | 1-14 days | 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. |
Countries
United States
Contacts
Primary ContactLeciel Bono, MS
Backup ContactAmanda Gibbs, MS candidate
Outcome results
None listed