Openly, Controlled Interventional Trial for Evaluating the Effectiveness of Whole-natural Hand-wash Formulations in Bacterial Removal and Openly Randomized Trial for Estimating the Relative Mildness of the Formulations
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hand Hygiene
- Sponsor
- Mother's Choice Ltd
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The efficacy of the tested hand-wash soaps in bacterial removal, presented as Log reduction
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the effectiveness of whole-natural hand-wash formulations in bacterial removal and to estimate the relative mildness of the formulations.
Detailed Description
Hand washing with soap and water is one of the main ways to prevent the spread of diseases in general and specifically, the spread of hospital-acquired diseases. Mother's Choice Company develops natural products and technologies which include hand-wash soap. The purpose of this project is developing a whole-natural hand wash soap including no harmful ingredients which will succeed to remove at least 99.9% (3 log reduction) of the hand transient microbiota. In addition, the soap will be mild enough to allow the use of dozens times a day. The procedure for evaluating soap effectiveness in bacterial removal will include in general: bacterial application on hands, hand washing with the tested soap, sampling of hands before and after hand washing. The procedure for soap mildness estimation will include exposure of specific area of the arm or the back skin to the soap and following up and grading the reaction of the skin.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For effectiveness test:
- •Healthy subjects aged 18-60 (both sexes).
- •Subjects must have short natural nails.
- •Subjects must remove all jewelry from their hands and forearms before participating.
- •Subjects must not expose their hands to any antimicrobial products for 24 hours before the test (including antimicrobial containing dish soaps, shampoos, and body washes).
- •Subjects must don safety glasses and lab coat prior to participating.
- •Subjects will not be exposed to more than one challenge microorganisms per week and more than five challenge microorganisms in total.
- •For mildness test:
- •Subject aged 18-60
- •Subjects should be healthy adults from both sexes (preferably more women than men)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The efficacy of the tested hand-wash soaps in bacterial removal, presented as Log reduction
Time Frame: one year
For log reduction determination the bacterial counts will be converted to log10. Next, the final quantity of bacteria recovered from hands after washing hands with the tested soap will be reduced from the start quantity of bacteria that was recovered from hands after bacterial application (before washing hands). For each soap the log reduction of each subject and the average log reduction will be presented.