Hand HygieneNCT02645110
Evaluation of Effectiveness and Mildness of Whole-natural Hand-wash Formulations
A study testing MC Hand Soap and Tap water in people with Hand Hygiene and Skin Irritation, run by Mother's Choice Ltd at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Hygiene, Skin Irritation
- What is being tested?
- MC Hand Soap and Tap water
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Mother's Choice LTD
Jerusalem, 9139102
Tova Silberstein, PhD, +972-2-9415200, clinical.mc.2013@gmail.com
Alon Moses, MD
About this study
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
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.
Read the 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.
- Conditions
- Hand Hygiene, Skin Irritation
- Being tested
- MC Hand Soap, Tap water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MC Hand SoapDevice
Washing hand with soap in comparison to hand washing with water alone
Tap waterDevice
Washing hand with water alone in comparison to hand washing with soap
| Study group | Role | What they receive |
|---|---|---|
| MC Hand soap | Experimental | For bacterial removal trial: Hand washing with the tested soap following bacterial application Receives: Device: MC Hand Soap |
| Water | Sham comparator | For bacterial removal trial: Hand washing with tap water alone following bacterial application Receives: Device: Tap water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand HygieneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mother's Choice Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allon Moses, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645110
- Sponsor's protocol ID
- 0602-15-HMO
- Status last verified
- Dec 2015
- First submitted
- 27 Dec 2015
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02645110
- Acronym / sponsor ID
- 0602-15-HMO
- Conditions
- Hand Hygiene, Skin Irritation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mother's Choice LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 1 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MC Hand soap | Experimental | Device: MC Hand SoapFor bacterial removal trial: Hand washing with the tested soap following bacterial application |
| Water | Sham comparator | Device: Tap waterFor bacterial removal trial: Hand washing with tap water alone following bacterial application |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MC Hand SoapWashing hand with soap in comparison to hand washing with water alone | Device | MC Hand soap |
| Tap waterWashing hand with water alone in comparison to hand washing with soap | Device | Water |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allon Moses, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MC Hand Soap and Tap water in people with Hand Hygiene and Skin Irritation, run by Mother's Choice Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tova Silberstein, PhD (+972-2-9415200, clinical.mc.2013@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of the tested hand-wash soaps in bacterial removal, presented as Log reduction (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2016.