| Eligibility |
Inclusion Criteria:
- Subjects may be of either sex, between the ages of 18 and 65 years, and of any race.
- Subjects must be able to read and understand English.
- Subjects must possess both hands and all ten digits.
- Subjects must have an average baseline population of at least 1.0 x 105 colony forming
units (CFU) per hand.
- Subjects must have no active skin rashes, dermatoses, hangnails, or breaks in the skin
of the hands or forearms. Subjects must also have no inflammatory skin conditions,
such as 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, a heart murmur, mitral valve
prolapse with heart murmur, 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:
- Have participated in a clinical study in the past 7 days or be currently participating
in another clinical study.
- Wash the hands or applying lotion within the 2-hour period prior to baseline sampling
or testing.
- 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 been regularly smoking or vaping over the past 2 years.
- Have limited mobility or dexterity that would hamper their ability to perform the
study 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 history of anaphylactic shock, anaphylactoid reaction, or anaphylactoid shock.
- 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.
- Contact the brain, cerebral membrane, middle ear and eyes with the test product and
such contact must be avoided.
- Be receiving any antibiotic medications during the 7-day pre-test period through
completion of the study.
- Be receiving any 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 and test periods 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.
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