Herpes Simplex Virus-1: A Pilot Study Using Hand Sanitizer

IRB-FY2022-172

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.

2022-04-08

2023-11-30

2023-11-30

Recruiting

Early phase I

20

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2023-11-18