Skin Irritancy PotentialPhase 4NCT04942496
A 96-hour Patch Test Study Using Healthy Human Volunteers to Assess the Skin Irritation Potential of 11 Topically Applied Formulations
A Phase 4 study testing Chlorhexidine Gluconate, Hibi Universal Bathing System and 0.1% SLS in people with Skin Irritancy Potential, run by Molnlycke Health Care AB at 1 site in United States.
Trial summary
This study is an evaluation of the irritation potential of 9 test products and 2 control materials applied to the backs of at least 44 volunteer human subjects over the course of a 96-hour period to determine and compare irritation scores. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Irritancy Potential
- What is being tested?
- Chlorhexidine Gluconate, Hibi Universal Bathing System and 0.1% SLS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2021to Jul 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects may be of either sex, at least at least 18 years of age but no more than 70 years of age, and of any race. Subjects that are 66 to 70 years of age are only eligible with proof of vaccination for COVID-19 having been completed at least 30 days prior to enrolling in the study.
- Subjects must be able to read and understand English.
- Subject's must have test sites on the skin of the back free of injury and in good condition (no active skin rashes, moderate to severe acne, tattoos on test areas, excessive hair, sunburn, excessive freckling, moles, scratches, breaks in the skin, etc.) and have no currently active skin diseases or skin conditions (for example, psoriasis, eczema) that may compromise subject safety or study integrity.
- Subjects must be in good general health and have no medical diagnosis of a physical condition, such as a current or recent severe illness, congenital heart disease, an organ transplant, medicated or uncontrolled diabetes, hepatitis B, hepatitis C, an immunocompromised condition such as AIDS (or HIV positive), lupus, fibromyalgia, ulcerative colitis, Crohn's disease, asthma, heart disease, hypertension, or medicated multiple sclerosis.
- Subjects must have read and signed the Informed Consent Form, List of Restricted Products, and Allowed and Restricted Products For Hand Cleaning During Coronavirus Disease 2019 (COVID-19) Pandemic prior to participating in the study, all located in the separate Informed Consent documents. Subjects must also have a current Authorization to Use and Disclose Protected Health Information Form on file at the testing facility.
Who cannot join
- Have participated in a clinical study in the past 7 days or be currently participating in another clinical study.
- Be experiencing any signs/symptoms of respiratory illness, including cough, fever (body temperature of ≥ 100.0 °F) or chills, shortness of breath or difficulty breathing, persistent pain or pressure in the chest, confusion or inability to respond to external stimuli, bluish lips/face, loss of taste/smell, sore throat, headache, nasal discharge ("runny nose"), frequent sneezing, or general fatigue / body aches.
- Have a current diagnosis of active Coronavirus Disease 2019 (COVID-19) or have been in close contact within the last 2 weeks of anyone who has been diagnosed as having contracted COVID-19.
- Have limited mobility that would hamper their ability to lay on their stomach for 45 minutes to an hour as directed.
- Have known allergies or sensitivities to latex (rubber), alcohols, sunscreens, deodorants, laundry detergents, topically applied fragrances, cleansers, soaps, lotions, or to common antibacterial agents, particularly chlorohexidine gluconate.
- 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).
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- Have a known hypersensitivity to the test product or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions.
- Subjects must not be receiving any antihistamines, or anti-inflammatory medications in the 48 hours prior to testing through completion of the study.
- Note - 81 mg of aspirin for preventative health reasons does not reduce inflammatory responses, and as such is not considered to be an exclusion to testing.
- Be receiving any antibiotic medications during the 7-day pre-test period through completion of the study.
- Be receiving any topical or systemic corticosteroids, steroids (including steroid medications used to treat asthma) other than for contraception, hormone therapy, or menopausal purposes during the 7-day pre-test period through completion of the study.
- Have any type of port (or portacath) or Peripherally Inserted Central Catheter (PICC).
- Be nursing a child.
- Be pregnant, plan to become pregnant or impregnate a sexual partner within the pre-test period through completion of the study.
- Have any medical condition or use any medications that, in the opinion of the Principal Investigator, or Consulting Physician(s) should preclude participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bioscience Laboratories, Inc
Bozeman, Montana, 59718
Kendra Drake, 406-587-5735 ext. 150, kdrake@biosciencelabs.com
About this study
Official title: A 96 Hour Patch Test Study Using Health Human Volunteers to Assess the Skin Irritation Potential of 11 Topically Applied Formulations
This study is an evaluation of the irritation potential of 9 test products and 2 control materials applied to the backs of at least 44 volunteer human subjects over the course of a 96-hour period to determine and compare irritation scores. Subjects will be required to complete a 7-day pre-test conditioning period prior to the test period. Finn Chambers® on Scanpor® will be used to apply each test material to a designated site on the skin of the parascapular region of the upper back every 24 hours for 96 hours. The sites will be evaluated visually prior to the first patch application and immediately following each patch removal. Instrument measurements of transepidermal water loss (TEWL) will also be performed prior to the first patch application and will start between 15 to 30 minutes, following removal of each patch.
- Conditions
- Skin Irritancy Potential
- Being tested
- Chlorhexidine Gluconate, Hibi Universal Bathing System, 0.1% SLS, Distilled Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine GluconateDrug
Antimicrobial Skin Wash
Hibi Universal Bathing SystemDevice
Cloths used for patient bathing
0.1% SLSOther
Positive control
Distilled WaterOther
Negative Control
| Study group | Role | What they receive |
|---|---|---|
| Test Product 1 (4% CHG) | Active comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back Receives: Drug: Chlorhexidine Gluconate |
| Test Product 2 (2% CHG) | Active comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back Receives: Drug: Chlorhexidine Gluconate |
| Test Product 3 (2% CHG) | Active comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back Receives: Drug: Chlorhexidine Gluconate |
| Test Product 4 (4% CHG) | Active comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back Receives: Drug: Chlorhexidine Gluconate; Device: Hibi Universal Bathing System |
| Test Product 5 (4% CHG) | Active comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back Receives: Drug: Chlorhexidine Gluconate |
| Test Product 6 (4% CHG) | Active comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back Receives: Drug: Chlorhexidine Gluconate |
| Test Product 7 (4% CHG) | Active comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back Receives: Drug: Chlorhexidine Gluconate |
| Test Product 8 (4% CHG) | Active comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back Receives: Drug: Chlorhexidine Gluconate |
| Test Product 9 (4% CHG) | Active comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back Receives: Drug: Chlorhexidine Gluconate |
| 0.1% Sodium Lauryl Sulfate | Placebo comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back. Product with known irritancy potential. Receives: Other: 0.1% SLS |
| Distilled Water | Placebo comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back. Product known not to cause irritancy Receives: Other: Distilled Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Evaluation of Skin Condition
The grading scale for skin condition is from 0-7 (0 - no evidence of irritation and 7-a strong reaction spreading beyond the test site) Reapplication stopped for any grade above 3.
Measured: assessed every 24 hours for a total of 96 hours
Secondary outcomes (1)
Transepidermal water loss
By quantitating the rate of water evaporation of the skin using a multi probe adapter system and Tewameter (r) TM 300 probe
Measured: assessed every 24 hours for a total of 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study startJun 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Irritancy PotentialStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioScience Laboratories, Inc.
- Responsible party
- Sponsor
- Investigators
- Kendra Drake, Principal investigator, BSLI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942496
- Sponsor's protocol ID
- #2011852-304
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2021
- Last updated
- 28 Jun 2021
- 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 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 96 Hour Patch Test Study Using Health Human Volunteers to Assess the Skin Irritation Potential of 11 Topically Applied Formulations
- ClinicalTrials.gov ID
- NCT04942496
- Acronym / sponsor ID
- #2011852-304
- Conditions
- Skin Irritancy Potential
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Collaborators
- BioScience Laboratories, Inc.
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 28 Jun 2021 (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 is an evaluation of the irritation potential of 9 test products and 2 control materials applied to the backs of at least 44 volunteer human subjects over the course of a 96-hour period to determine and compare irritation scores. Subjects will be required to complete a 7-day pre-test conditioning period prior to the test period. Finn Chambers® on Scanpor® will be used to apply each test material to a designated site on the skin of the parascapular region of the upper back every 24 hours for 96 hours. The sites will be evaluated visually prior to the first patch application and immediately following each patch removal. Instrument measurements of transepidermal water loss (TEWL) will also be performed prior to the first patch application and will start between 15 to 30 minutes, following removal of each patch.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Test Product 1 (4% CHG) | Active comparator | Drug: Chlorhexidine GluconateProduct applied to patch and randomly assigned application site on right and left parascapular regions of upper back |
| Test Product 2 (2% CHG) | Active comparator | Drug: Chlorhexidine GluconateProduct applied to patch and randomly assigned application site on right and left parascapular regions of upper back |
| Test Product 3 (2% CHG) | Active comparator | Drug: Chlorhexidine GluconateProduct applied to patch and randomly assigned application site on right and left parascapular regions of upper back |
| Test Product 4 (4% CHG) | Active comparator | Drug: Chlorhexidine Gluconate, Device: Hibi Universal Bathing SystemProduct applied to patch and randomly assigned application site on right and left parascapular regions of upper back |
| Test Product 5 (4% CHG) | Active comparator | Drug: Chlorhexidine GluconateProduct applied to patch and randomly assigned application site on right and left parascapular regions of upper back |
| Test Product 6 (4% CHG) | Active comparator | Drug: Chlorhexidine GluconateProduct applied to patch and randomly assigned application site on right and left parascapular regions of upper back |
| Test Product 7 (4% CHG) | Active comparator | Drug: Chlorhexidine GluconateProduct applied to patch and randomly assigned application site on right and left parascapular regions of upper back |
| Test Product 8 (4% CHG) | Active comparator | Drug: Chlorhexidine GluconateProduct applied to patch and randomly assigned application site on right and left parascapular regions of upper back |
| Test Product 9 (4% CHG) | Active comparator | Drug: Chlorhexidine GluconateProduct applied to patch and randomly assigned application site on right and left parascapular regions of upper back |
| 0.1% Sodium Lauryl Sulfate | Placebo comparator | Other: 0.1% SLSProduct applied to patch and randomly assigned application site on right and left parascapular regions of upper back. Product with known irritancy potential. |
| Distilled Water | Placebo comparator | Other: Distilled WaterProduct applied to patch and randomly assigned application site on right and left parascapular regions of upper back. Product known not to cause irritancy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects may be of either sex, at least at least 18 years of age but no more than 70 years of age, and of any race. Subjects that are 66 to 70 years of age are only eligible with proof of vaccination for COVID-19 having been completed at least 30 days prior to enrolling in the study.
- Subjects must be able to read and understand English.
- Subject's must have test sites on the skin of the back free of injury and in good condition (no active skin rashes, moderate to severe acne, tattoos on test areas, excessive hair, sunburn, excessive freckling, moles, scratches, breaks in the skin, etc.) and have no currently active skin diseases or skin conditions (for example, psoriasis, eczema) that may compromise subject safety or study integrity.
- Subjects must be in good general health and have no medical diagnosis of a physical condition, such as a current or recent severe illness, congenital heart disease, an organ transplant, medicated or uncontrolled diabetes, hepatitis B, hepatitis C, an immunocompromised condition such as AIDS (or HIV positive), lupus, fibromyalgia, ulcerative colitis, Crohn's disease, asthma, heart disease, hypertension, or medicated multiple sclerosis.
- Subjects must have read and signed the Informed Consent Form, List of Restricted Products, and Allowed and Restricted Products For Hand Cleaning During Coronavirus Disease 2019 (COVID-19) Pandemic prior to participating in the study, all located in the separate Informed Consent documents. Subjects must also have a current Authorization to Use and Disclose Protected Health Information Form on file at the testing facility.
Key exclusion criteria (15 listed)
- Have participated in a clinical study in the past 7 days or be currently participating in another clinical study.
- Be experiencing any signs/symptoms of respiratory illness, including cough, fever (body temperature of ≥ 100.0 °F) or chills, shortness of breath or difficulty breathing, persistent pain or pressure in the chest, confusion or inability to respond to external stimuli, bluish lips/face, loss of taste/smell, sore throat, headache, nasal discharge ("runny nose"), frequent sneezing, or general fatigue / body aches.
- Have a current diagnosis of active Coronavirus Disease 2019 (COVID-19) or have been in close contact within the last 2 weeks of anyone who has been diagnosed as having contracted COVID-19.
- Have limited mobility that would hamper their ability to lay on their stomach for 45 minutes to an hour as directed.
- Have known allergies or sensitivities to latex (rubber), alcohols, sunscreens, deodorants, laundry detergents, topically applied fragrances, cleansers, soaps, lotions, or to common antibacterial agents, particularly chlorohexidine gluconate.
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 GluconateAntimicrobial Skin Wash | Drug | Test Product 1 (4% CHG), Test Product 2 (2% CHG), Test Product 3 (2% CHG), Test Product 4 (4% CHG), Test Product 5 (4% CHG), Test Product 6 (4% CHG), Test Product 7 (4% CHG), Test Product 8 (4% CHG), Test Product 9 (4% CHG) |
| Hibi Universal Bathing SystemCloths used for patient bathing | Device | Test Product 4 (4% CHG) |
| 0.1% SLSPositive control | Other | 0.1% Sodium Lauryl Sulfate |
| Distilled WaterNegative Control | Other | Distilled Water |
Primary outcome
Visual Evaluation of Skin Condition
Time frame: assessed every 24 hours for a total of 96 hours
The grading scale for skin condition is from 0-7 (0 - no evidence of irritation and 7-a strong reaction spreading beyond the test site) Reapplication stopped for any grade above 3.
1 secondary outcome
Transepidermal water loss
Time frame: assessed every 24 hours for a total of 96 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- 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.
Kendra Drake 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, Hibi Universal Bathing System and 0.1% SLS in people with Skin Irritancy Potential, 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 5 inclusion and 15 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 28 Jun 2021. 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. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Scott ((+44) 7967769991, caroline.scott@molnlycke.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Evaluation of Skin Condition (time frame: assessed every 24 hours for a total of 96 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 28 Jun 2021.