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

NCT02645110 | Unknown DMC

• 1 other identifier: 0602-15-HMO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Hygiene; Skin Irritation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

MC Hand soap

EXPERIMENTAL

For bacterial removal trial: Hand washing with the tested soap following bacterial application

Device: MC Hand Soap

Water

SHAM COMPARATOR

For bacterial removal trial: Hand washing with tap water alone following bacterial application

Device: Tap water

Interventions

MC Hand Soap DEVICE

Washing hand with soap in comparison to hand washing with water alone

MC Hand soap

Tap water DEVICE

Washing hand with water alone in comparison to hand washing with soap

Water

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mother's Choice Ltd: lead

Study Sites (1)

Mother's Choice LTD

Jerusalem, 9139102, Israel

Location

Study Officials

• Allon Moses, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tova Silberstein, PhD

CONTACT

+972-2-9415200; clinical.mc.2013@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2015
• First Posted: January 1, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: January 1, 2017
• Last Updated: January 1, 2016

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will share

Locations

IL (1)