A 96-hour Patch Test Study Using Healthy Human Volunteers to Assess the Skin Irritation Potential of 11 Topically Applied Formulations
NCT ID: NCT04942496
Last Updated: 2021-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
44 participants
INTERVENTIONAL
2021-06-30
2021-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Test Product 1 (4% CHG)
Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back
Chlorhexidine Gluconate
Antimicrobial Skin Wash
Test Product 2 (2% CHG)
Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back
Chlorhexidine Gluconate
Antimicrobial Skin Wash
Test Product 3 (2% CHG)
Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back
Chlorhexidine Gluconate
Antimicrobial Skin Wash
Test Product 4 (4% CHG)
Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back
Chlorhexidine Gluconate
Antimicrobial Skin Wash
Hibi Universal Bathing System
Cloths used for patient bathing
Test Product 5 (4% CHG)
Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back
Chlorhexidine Gluconate
Antimicrobial Skin Wash
Test Product 6 (4% CHG)
Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back
Chlorhexidine Gluconate
Antimicrobial Skin Wash
Test Product 7 (4% CHG)
Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back
Chlorhexidine Gluconate
Antimicrobial Skin Wash
Test Product 8 (4% CHG)
Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back
Chlorhexidine Gluconate
Antimicrobial Skin Wash
Test Product 9 (4% CHG)
Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back
Chlorhexidine Gluconate
Antimicrobial Skin Wash
0.1% Sodium Lauryl Sulfate
Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back. Product with known irritancy potential.
0.1% SLS
Positive control
Distilled Water
Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back. Product known not to cause irritancy
Distilled Water
Negative Control
Interventions
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Chlorhexidine Gluconate
Antimicrobial Skin Wash
Hibi Universal Bathing System
Cloths used for patient bathing
0.1% SLS
Positive control
Distilled Water
Negative Control
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
* 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.
18 Years
70 Years
ALL
Yes
Sponsors
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BioScience Laboratories, Inc.
INDUSTRY
Molnlycke Health Care AB
INDUSTRY
Responsible Party
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Principal Investigators
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Kendra Drake
Role: PRINCIPAL_INVESTIGATOR
BSLI
Locations
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Bioscience Laboratories, Inc
Bozeman, Montana, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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#2011852-304
Identifier Type: -
Identifier Source: org_study_id
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