Overview

Pilot Clinical Trial - Comparative Study of Two Material Concentration of OD-141309

Status:
Not yet recruiting
Trial end date:
2022-04-01
Target enrollment:
0
Participant gender:
All
Summary
A sufficient number of subjects will be entered into testing to complete 42 subjects per each of the 2 test and 2 control configurations. A total of 84 subjects, testing bi-laterally (168 abdomen and groin sites in total completed, 42 abdomen and groin sites per each test and control material) will be evaluated using the standardized ASTM E1173 test method. Following a 14-day restriction period, subjects will be sampled for baseline, 10 minutes, 6 hours, and 24 hours post application (subjects will not be sequestered) for microbial reduction evaluations. Test day baseline criteria will be set at: abdomen: ≥ 3.0 log10 CFU/cm2, and groin: ≥ 5.0 log10 CFU/cm2.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Zaycor Healthcare Corp
Collaborator:
BioScience Laboratories, Inc.
Treatments:
Anti-Bacterial Agents
Anti-Infective Agents
Criteria
Inclusion Criteria:

- Subjects may be of either sex, at least 18 years of age and no more than 65 years of
age, and of any race.

- Subjects must be able to read and understand English.

- Subjects must read and sign an Informed Consent Form, List of Restricted Products
Form, and Allowed and Restricted Products for Hand Cleaning During Coronavirus Disease
2019 (COVID-19) Pandemic Form prior to participating in the study, as well as have an
Authorization to Use and Disclose Protected Health Information Form on file at the
testing facility.

- 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, mitral valve prolapse with
heart murmur, fibromyalgia, ulcerative colitis, Crohn's disease, asthma, lung disease,
liver disease, kidney disease, heart disease, hypertension, an immunocompromised
condition such as AIDS (or HIV positive), lupus, medicated multiple sclerosis and must
not have a history of smoking or vaping in the past 2 years.

- Subjects will have test sites on the skin of the abdomen and/or inguinal free of
injury and in good condition (no active skin rashes, excessive freckling, moles,
scratches, breaks in the skin, etc.) and have no currently active skin diseases or
skin conditions (for example, contact dermatitis, psoriasis or eczema) that may
compromise subject safety or study integrity.

- Subjects must have skin within 6 inches of the test sites that is free of tattoos,
dermatoses, abrasions, cuts, lesions or other skin disorders. Subjects with tattoos,
scars, active skin rashes, or breaks in the skin of test sites, skin blemishes, such
as dry scabs or warts, may be admitted at the discretion of the Principal
Investigator, Subinvestigators, or Consulting Physicians.

- Subjects must be able to lay on their backs with one leg bent to expose inguinal test
site for approximately 20 minutes

Exclusion Criteria:

- Known allergies to vinyl, latex (rubber), alcohols, metals, tapes or adhesives, inks,
sunscreens, deodorants, laundry detergents, topically applied fragrances, cleansers,
or to common antibacterial agents found in soaps or lotions, particularly
chlorhexidine gluconate, perillyl alcohol or isopropanol.

- Have experienced hives (raised welts) as a reaction to anything that contacted the
skin with the exception of items that cause hives as a reaction to the general
population (e.g. poison oak and poison ivy).

- Use of systemic or topical antibiotic medications.

- Use of systemic or topical steroids, other than for contraception, hormone therapy,
post-menopausal indications. This includes steroid medications used to treat asthma.
Note: topically applied hormonal steroids used for post-menopausal reasons must not
get on the test sites.

- Any type of port (or portacath) or Peripherally Inserted Central Catheter (PICC).

- Pregnancy, plans to become pregnant or impregnate a sexual partner within the pre-test
and test period of the study, or nursing a child. Female subjects must have a negative
urine pregnancy test documented before treatment with test materials.

- Current participation or participation in a clinical study in the 14 days prior to the
first lab visit.

- Any medical condition or use of any medications that, in the opinion of the Principal
Investigator or Consulting Physicians, would preclude participation.