An Early Phase 1 interventional study of Purell Hand Sanitizer and Medical Grade Mineral Oil in Virus, HSV-1 and Herpes Simplex 1, sponsored by Leciel Bono. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Leciel Bono · Early Phase 1, Interventional, and Treatment
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.
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.
656 studies on the registry are indexed under Virus Diseases; 85 are open to participants now.
This study's planned enrollment of 20 is below the median of 100 across 464 interventional studies indexed under Virus Diseases.
Browse Virus Diseases studies →This is the only study on the registry with Leciel Bono as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For the purpose of this study participants must be:
Exclusion Criteria:
For the purpose of this study participants cannot:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Purell 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 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.
Drug: Medical Grade Mineral Oil
Active ingredient. Ethyl alcohol 70%
Also known as: Hand Sanitizer
Inert ingredients: Saturated hydrocarbons, with a purity and chemical structure that differs substantially from food-grade or technical-/industrial-grade mineral oils.
Also known as: Mineral Oil
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.
Time frame: 1-14 days
Level of Pain during Treatment
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.
Time frame: 1-14 days
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.
Time frame: 1-14 days
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.
Time frame: 1-14 days
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.