Clinical trial

Wet Time for a Foam Hand Sanitizer With 70% Ethyl Alcohol

Name
MED-2022-DIV60-002
Description
Hand sanitizers are a standard of hygiene requirements. They must be effective at reducing germ count on the hands while ideally providing emollients to moisturize the skin after use. Spectrum™ Advanced Hand Sanitizer Foam (70%) (hereby referred to as Spectrum Advanced Foam) kills over 99.99% of germs within 15 seconds while boasting double digit increases in hand moisture after two weeks of use. In 2002 and 2009 the Center for Disease Control and Prevention (CDC) and World Health Organization (WHO) published guidance that hands should remain wet for at least 15 seconds while being rubbed together after application of an alcohol-based hand rub, though the recommendations do not specify the volume of product to be apply. This study will evaluate the "wet time" of Spectrum Advanced Foam, which will be defined as the length of time in which the sanitizer foam stays wet on the hands while the participant rubs their hands with the foam sanitizer. The participant will first be asked to wash and dry their hands. Participants will review the appropriate hand sanitizer application steps, as detailed by the WHO guidance. Then, a 1.0 milliliter (mL) or 1.4 mL aliquot of Spectrum Advanced Foam will be dispensed from an automated dispenser to the participant's hands. The participant will be asked to rub their hands together following the WHO method for hand sanitizer application until they declare the product has dried sufficiently for the donning of medical gloves. Study personnel will measure the wet time of Spectrum Advanced foam using a stopwatch.
Trial arms
Trial start
2022-12-12
Estimated PCD
2023-01-12
Trial end
2023-01-12
Status
Completed
Phase
Early phase I
Treatment
Alcohol hand sanitizer foam
1mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry. Other Name: Medline Spectrum™ Advanced Hand Sanitizer Foam (70%)
Arms:
All participants
Size
46
Primary endpoint
Foam Sanitizer Wet Time Duration
4 weeks
Eligibility criteria
Inclusion Criteria: * Individual ≥ 18 years of age Exclusion Criteria: * Individual has a self reported skin condition that might result in irritation from the hand sanitizer. * Individual has a known allergy to the ingredients in the test product.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 46, 'type': 'ACTUAL'}}
Updated at
2023-02-24

1 organization

1 product

1 indication

Organization
Medline Industries