Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06135844
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-10-30
Brief Title:
Hand Sanitizer Use for Herpes Simplex Virus-1
Sponsor:
Leciel Bono
Organization:
Idaho State University
Study Overview
Official Title:
Herpes Simplex Virus-1 A Pilot Study Using Hand Sanitizer
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None