General Skin CleansingPhase 4NCT04235985
Evaluation of Chlorhexidine Gluconate Concentration on Skin of Human Subjects Following Multiple Application Times
A Phase 4 study testing Chlorhexidine Gluconate with HUBS in people with General Skin Cleansing, run by Molnlycke Health Care AB at 1 site in United States.
Trial summary
This study will evaluate the amount of chlorhexidine gluconate (CHG) present on treated skin of human volunteers following different application times with a test material bathing system. 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 with HUBS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2020to 2 Apr 2020
- 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 must be at least 18 years of age and can be of either sex and of any race.
- Subjects must be able to read and understand English.
- Subjects must possess both forearms and have a minimum forearm length (wrist crease to elbow crease) of 8.25 inches [21 cm].
- Subjects must be in good general health (i.e., no current or recent severe illness) and have no medical diagnosis of mitral valve prolapse with heart murmur, congenital heart disease, an organ transplant, medicated or uncontrolled diabetes, hepatitis B or C, an immunocompromised condition such as AIDS (or HIV positive), lupus, fibromyalgia, ulcerative colitis, Crohn's disease, moderate to severe asthma (requiring daily use of medication), or medicated multiple sclerosis.
Who cannot join
- Participation in a clinical study within 7 days of participating in this study or current participation in another clinical study.
- Presence of tattoos, active skin rashes, dermatoses, or breaks in the skin of the forearms or hands. Subjects must also have no inflammatory skin conditions (such as atopic dermatitis / eczema, contact dermatitis, or psoriasis) anywhere on the body.
- Known allergies or sensitivities to latex (natural rubber), alcohols, sunscreens, deodorants, laundry detergents, inks, metals, topically-applied fragrances (e.g., colognes or perfumes), cleansers, soaps, lotions, or to common antibacterial agents particularly chlorhexidine gluconate (CHG).
- Have experienced hives (raised welts) as a reaction to anything that contacted the skin, with the exception of plants known to cause reactions for most humans (e.g., poison oak or poison ivy).
- Have a history of anaphylactic shock, anaphylactoid reaction, or anaphylactoid shock.
- Any prosthetic device or joint (e.g., pins, screws, plates, or rods) installed in the arms within the last 6 months.
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- Any type of indwelling port 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.
- Any medical condition or use of any medications that, in the opinion of the Principal Investigator or Consulting Physicians, 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 Chlorhexidine Gluconate Concentration on Skin of Human Subjects Following
This study will evaluate the amount of chlorhexidine gluconate (CHG) present on treated skin of human volunteers following different application times with a test material bathing system. The amount of recovered CHG that resides on the skin following each of the evaluated application times will be evaluated via high performance liquid chromatography with ultraviolet detection (HPLC-UV) and correlated with the MIC values determined separately.
- Conditions
- General Skin Cleansing
- Being tested
- Chlorhexidine Gluconate with HUBS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine Gluconate with HUBSCombination product
4% CHG soap will be applied to HUBS following manufacturers recommendation and applied to skin for different application times as dictated by the randomization of the marked sites on the forearm. Followed by a HUBS moistened with water.
| Study group | Role | What they receive |
|---|---|---|
| All time points | Other | Not described Receives: Combination Product: Chlorhexidine Gluconate with HUBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chlorhexidine skin levels
To find out how much CHG is left on the skin with different application times
Measured: range from 15 to 120 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start23 Jan 2020
- Primary completion2 Apr 2020
- Study completion2 Apr 2020
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Volunteer forearms will be marked with 6 test sites which will be randomly assigned a time point for the application.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Russell Griggs, Principal investigator, BSLI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235985
- Sponsor's protocol ID
- #1906236-150B
- Status last verified
- Aug 2020
- First submitted
- 17 Jan 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Chlorhexidine Gluconate Concentration on Skin of Human Subjects Following
- ClinicalTrials.gov ID
- NCT04235985
- Acronym / sponsor ID
- #1906236-150B
- Conditions
- General Skin Cleansing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 2 Apr 2020 (actual)
- First posted
- 22 Jan 2020 (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.
This study will evaluate the amount of chlorhexidine gluconate (CHG) present on treated skin of human volunteers following different application times with a test material bathing system. The amount of recovered CHG that resides on the skin following each of the evaluated application times will be evaluated via high performance liquid chromatography with ultraviolet detection (HPLC-UV) and correlated with the MIC values determined separately.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Volunteer forearms will be marked with 6 test sites which will be randomly assigned a time point for the application.
| Arm | Type | Receives |
|---|---|---|
| All time points | Other | Combination Product: Chlorhexidine Gluconate with HUBS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must be at least 18 years of age and can be of either sex and of any race.
- Subjects must be able to read and understand English.
- Subjects must possess both forearms and have a minimum forearm length (wrist crease to elbow crease) of 8.25 inches [21 cm].
- Subjects must be in good general health (i.e., no current or recent severe illness) and have no medical diagnosis of mitral valve prolapse with heart murmur, congenital heart disease, an organ transplant, medicated or uncontrolled diabetes, hepatitis B or C, an immunocompromised condition such as AIDS (or HIV positive), lupus, fibromyalgia, ulcerative colitis, Crohn's disease, moderate to severe asthma (requiring daily use of medication), or medicated multiple sclerosis.
Key exclusion criteria (9 listed)
- Participation in a clinical study within 7 days of participating in this study or current participation in another clinical study.
- Presence of tattoos, active skin rashes, dermatoses, or breaks in the skin of the forearms or hands. Subjects must also have no inflammatory skin conditions (such as atopic dermatitis / eczema, contact dermatitis, or psoriasis) anywhere on the body.
- Known allergies or sensitivities to latex (natural rubber), alcohols, sunscreens, deodorants, laundry detergents, inks, metals, topically-applied fragrances (e.g., colognes or perfumes), cleansers, soaps, lotions, or to common antibacterial agents particularly chlorhexidine gluconate (CHG).
- Have experienced hives (raised welts) as a reaction to anything that contacted the skin, with the exception of plants known to cause reactions for most humans (e.g., poison oak or poison ivy).
- Have a history of anaphylactic shock, anaphylactoid reaction, or anaphylactoid shock.
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 Gluconate with HUBS4% CHG soap will be applied to HUBS following manufacturers recommendation and applied to skin for different application times as dictated by the randomization of the marked sites on the forearm. Followed by a HUBS moistened with water. | Combination product | All time points |
Primary outcome
Chlorhexidine skin levels
Time frame: range from 15 to 120 seconds
To find out how much CHG is left on the skin with different application times
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 12 Aug 2020.
- Individual participant dataSharing planned: No
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 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 with HUBS in people with General Skin Cleansing, run by Molnlycke Health Care AB 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 4 inclusion and 9 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 12 Aug 2020. 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?
Chlorhexidine skin levels (time frame: range from 15 to 120 seconds). 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 12 Aug 2020.