General Skin CleansingPhase 4NCT03372122
Removal of Bacterial Spores in Adults on Skin
A Phase 4 study testing Chlorhexidine Gluconate and HUBS with Hibiclens in people with General Skin Cleansing, run by Caroline Scott at 1 site in United States.
Trial summary
The aim of this study is to compare the effectiveness of removal of spores and dirt from the skin using a single cloth bath against a cloth bath with extra rinse step, to establish whether the extra rinse stage will lead to the removal of a higher level of spores and dirt. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- General Skin Cleansing
- What is being tested?
- Chlorhexidine Gluconate and HUBS with Hibiclens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2017to 7 Mar 2018
- Phase
- Phase 4
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects can be of either sex, 18 to 65 years of age, and of any race.
- Subjects must be able to read and understand English.
- Subjects must possess both forearms.
- Subjects must have healthy and short (< 1 mm in length) fingernails and cuticles with no defects. Subjects must also have no nail extensions, artificial nails, or nail polish and must not be wearing any jewelry that cannot be removed from the hands/forearms prior to testing.
- Subjects must have no tattoos, active skin rashes, dermatoses, or breaks in the skin of the hands or forearms. Subjects must also have no inflammatory skin conditions, such as atopic dermatitis / eczema or psoriasis, anywhere on the body.
- Subjects must be in good general health and have no medical diagnosis of a physical condition, such as a current or recent severe illness, medicated or uncontrolled diabetes, hepatitis B, hepatitis C, an organ transplant, a heart murmur, mitral valve prolapse with heart murmur, fibromyalgia, ulcerative colitis, Crohn's disease, moderate/severe asthma requiring daily use of medication, an immunocompromised condition such as AIDS (or HIV positive), lupus, or medicated multiple sclerosis.
- Subjects must read and sign the Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and List of Restricted Products prior to participating in the study.
Who cannot join
- Participation in a clinical study within 7 days of signing the informed consent for this study or current participation in another clinical study.
- Known allergies or sensitivities to latex (natural rubber), alcohols, sunscreens, deodorants, laundry detergents, inks, metals, topically-applied fragrances, cleansers, soaps, lotions, or to common antibacterial agents particularly chlorhexidine gluconate.
- Have experienced hives (raised welts) as a reaction to anything that contacted the skin.
- Use of systemic or topical antibiotic medications during either the 7-day pre-test period or on the test day.
- Use of systemic or topical steroids, other than for contraception, hormone therapy, or post-menopausal indications, during the 7-day pre-test period or on the test day. This includes steroid medications used to treat asthma.
- Have an Implanon/Nexplanon or any other dermal-implanted birth control device.
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- Any prosthetic device or joint (e.g., pins, screws, plates, rods, or dental implants) anywhere in the body.
- Any type of indwelling port (or portacath) or Peripherally Inserted Central Catheter (PICC).
- Subject is pregnant, plans to become pregnant or impregnate a sexual partner within the pre-test and test periods of the study, or is nursing a child.
- Subject must not be responsible for diapering, care of wounds, intravenous management, or other bed-ridden-related care roles: have any responsibility for care of children under age 3: or be living with an immunocompromised individual.
- Any medical condition or use of any medications that, in the opinion of the Principal Investigator or consulting physician, should preclude participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bioscience Laboratories, Inc
Bozeman, Montana, 59718
About this study
Official title: Evaluation of the Ability of Two Products to Remove Bacterial Spores From Subjects' Forearms
The aim of this study is to compare the effectiveness of removal of spores and dirt from the skin using a single cloth bath against a cloth bath with extra rinse step, to establish whether the extra rinse stage will lead to the removal of a higher level of spores and dirt.
Read the detailed description
The purpose of this study is to evaluate and compare the ability of two test materials to remove Clostridium difficile (ATCC #700057) spores with a tripartite soil load from subjects' forearms. For this study, removal of Clostridium difficile and the associated organic soil load will be used as an indicator of potential removal efficacy for difficult-to-remove microorganisms and associated organic matter from human skin.
All test materials are currently marketed products
- Conditions
- General Skin Cleansing
- Being tested
- Chlorhexidine Gluconate, HUBS with Hibiclens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine GluconateDrug
A cloth to cleanse and disinfect the skin
HUBS with HibiclensCombination product
A dry cloth to be used in combination with water and antimicrobial soap to cleanse and disinfect the skin
| Study group | Role | What they receive |
|---|---|---|
| SAGE Chlorhexidine Gluconate Cloth | Active comparator | Ready to use disinfectant cloth Receives: Drug: Chlorhexidine Gluconate |
| HUBS with Hibiclens | Active comparator | Dry cloths to be used with water and disinfectant Receives: Combination Product: HUBS with Hibiclens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Removal of Clostridium difficile and the associated organic soil load will be used as an indicator of potential removal efficacy for difficult-to-remove microorganisms and associated organic matter from human skin
As a measure of the ability of the test materials to remove spores from the skin, reductions will be calculated by subtracting the population of spores recovered from a treated sites from the population recovered from the baseline sites.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start13 Dec 2017
- Primary completion8 Jan 2018
- Study completion7 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Skin CleansingStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The two study products will be assigned to opposite forearms per a computer-generated randomization schedule. Additionally, the location for baseline and post-product samples will be randomly assigned to the two longitudinally-arranged sites per forearm.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caroline Scott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Caroline Scott, Molnlycke Health Care AB
- Investigators
- Russell Griggs, M.S, CCRC, Principal investigator, BSLI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372122
- Sponsor's protocol ID
- #170104-150
- Status last verified
- Mar 2018
- First submitted
- 4 Dec 2017
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ability of Two Products to Remove Bacterial Spores From Subjects' Forearms
- ClinicalTrials.gov ID
- NCT03372122
- Acronym / sponsor ID
- #170104-150
- Conditions
- General Skin Cleansing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Caroline ScottIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 7 Mar 2018 (actual)
- First posted
- 13 Dec 2017 (actual)
- 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 aim of this study is to compare the effectiveness of removal of spores and dirt from the skin using a single cloth bath against a cloth bath with extra rinse step, to establish whether the extra rinse stage will lead to the removal of a higher level of spores and dirt.
Detailed description
The purpose of this study is to evaluate and compare the ability of two test materials to remove Clostridium difficile (ATCC #700057) spores with a tripartite soil load from subjects' forearms. For this study, removal of Clostridium difficile and the associated organic soil load will be used as an indicator of potential removal efficacy for difficult-to-remove microorganisms and associated organic matter from human skin.
All test materials are currently marketed products
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The two study products will be assigned to opposite forearms per a computer-generated randomization schedule. Additionally, the location for baseline and post-product samples will be randomly assigned to the two longitudinally-arranged sites per forearm.
| Arm | Type | Receives |
|---|---|---|
| SAGE Chlorhexidine Gluconate Cloth | Active comparator | Drug: Chlorhexidine GluconateReady to use disinfectant cloth |
| HUBS with Hibiclens | Active comparator | Combination Product: HUBS with HibiclensDry cloths to be used with water and disinfectant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects can be of either sex, 18 to 65 years of age, and of any race.
- Subjects must be able to read and understand English.
- Subjects must possess both forearms.
- Subjects must have healthy and short (< 1 mm in length) fingernails and cuticles with no defects. Subjects must also have no nail extensions, artificial nails, or nail polish and must not be wearing any jewelry that cannot be removed from the hands/forearms prior to testing.
- Subjects must have no tattoos, active skin rashes, dermatoses, or breaks in the skin of the hands or forearms. Subjects must also have no inflammatory skin conditions, such as atopic dermatitis / eczema or psoriasis, anywhere on the body.
Key exclusion criteria (11 listed)
- Participation in a clinical study within 7 days of signing the informed consent for this study or current participation in another clinical study.
- Known allergies or sensitivities to latex (natural rubber), alcohols, sunscreens, deodorants, laundry detergents, inks, metals, topically-applied fragrances, cleansers, soaps, lotions, or to common antibacterial agents particularly chlorhexidine gluconate.
- Have experienced hives (raised welts) as a reaction to anything that contacted the skin.
- Use of systemic or topical antibiotic medications during either the 7-day pre-test period or on the test day.
- Use of systemic or topical steroids, other than for contraception, hormone therapy, or post-menopausal indications, during the 7-day pre-test period or on the test day. This includes steroid medications used to treat asthma.
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 |
|---|---|---|
| Chlorhexidine GluconateA cloth to cleanse and disinfect the skin | Drug | SAGE Chlorhexidine Gluconate Cloth |
| HUBS with HibiclensA dry cloth to be used in combination with water and antimicrobial soap to cleanse and disinfect the skin | Combination product | HUBS with Hibiclens |
Primary outcome
Removal of Clostridium difficile and the associated organic soil load will be used as an indicator of potential removal efficacy for difficult-to-remove microorganisms and associated organic matter from human skin
Time frame: 2 hours
As a measure of the ability of the test materials to remove spores from the skin, reductions will be calculated by subtracting the population of spores recovered from a treated sites from the population recovered from the baseline sites.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Individual participant dataSharing planned: Undecided
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.
Russell Griggs, M.S, CCRC principal investigator
BSLI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlorhexidine Gluconate and HUBS with Hibiclens in people with General Skin Cleansing, run by Caroline Scott at 1 site in United States.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 13 Mar 2018. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Removal of Clostridium difficile and the associated organic soil load will be used as an indicator of potential removal efficacy for difficult-to-remove microorganisms and associated organic matter from human skin (time frame: 2 hours). 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 13 Mar 2018.