Evaluation of Effectiveness and Mildness of Whole-natural Hand-wash Formulations

Hand Hygiene Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02645110
• Other study ID #: 0602-15-HMO
• Status: Not yet recruiting
• Phase: N/A
• First received: December 27, 2015
• Last updated: December 31, 2015
• Start date: January 2016
• Est. completion date: January 2017

Study information

• Verified date: December 2015
• Source: Mother's Choice Ltd
• Contact: Tova Silberstein, PhD
• Phone: +972-2-9415200
• Email: clinical.mc.2013[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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)

• Subjects would be able to participate in one study per four weeks.

Exclusion Criteria

For effectiveness test:

• Subjects cannot have any breaks or cuts in the skin of the hands or forearms.

• Subjects cannot have a medical diagnosis of a physical condition.

• Subjects cannot have allergies to detergents, hand hygiene products, perfume or any other substance they are going to be expose to.

• Subjects must not be on antibiotics or have been on antibiotics in the past 14 days.

• Subjects cannot participate if they have participated in other clinical trials within the past 14 days.

• Subjects cannot have any other general health or skin issues not mentioned above.

• Subjects cannot be pregnant or nursing.

For mildness test:

• pregnant or nursing subjects

• Subjects with an allergy or a skin disease which interferes with the proper results of the tests.

• Subjects who are taking medications which can interfere with the proper results of the tests. For example: systemic corticosteroids, topical steroids applied to the test area.

• Subjects with sun or phototherapy induced tanning at the test area.

• Subject who had been participating in allergy tests within four weeks prior to the present tests.

• Subjects could not use cosmetics for the face area except for the use of lipstick and makeup around the eyes for two weeks before the test.

• Subjects can use only mild soap and no more than once a day.

• Subjects should avoid drinking alcohol, coffee, tea and smoking on the test day.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hand Hygiene
• Skin Irritation

Intervention

Device:
• MC Hand Soap
Washing hand with soap in comparison to hand washing with water alone
• Tap water
Washing hand with water alone in comparison to hand washing with soap

Locations

Country	Name	City	State
Israel	Mother's Choice LTD	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Mother's Choice Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of the tested hand-wash soaps in bacterial removal, presented as Log reduction	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.	one year	No