Clinical Evaluation of the Residual Antimicrobial Activity

NCT04495920 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 2005367-150
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the residual antimicrobial efficacy of one test product as defined by the difference between the number of a challenge bacterial species recovered following exposure to the test product and the number recovered when untreated (negative control). The challenge bacterial species to be used is Staphylococcus aureus (ATCC #6538) (S. aureus). Testing will be carried out using a modification of the standardized test method described in ASTM E2752-10 (2015) Standard Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products. Bacterial recoveries will be assayed after application oftest material, using the forearms as a substrate.

Conditions

Bacterial Overgrowth

Keywords

Residual; ASTME2752; Antimicrobial

Outcome Measures

Primary Outcomes (1)

• Significant Log 10 Microbial Change 4 hours post application

  4 hours

Study Arms (1)

Test product

EXPERIMENTAL

Drug: CGB-S-100

Interventions

CGB-S-100 DRUG

Alcohol and choline geranate

Also known as: IonLAST gel (CGB-S-100 gel)

Test product

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects may be of either sex, between the ages of 18 and 65 years, and of any race.
• Subjects must possess both forearms.
• Subjects must have no active skin rashes, dermatoses, or breaks in the skin of the hands or forearms. Subjects must also have no inflammatory skin conditions, such as atopic 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 an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and List of Restricted Products.

You may not qualify if:

• Participation in a clinical study in the past 7 days or current participation in another clinical study.
• 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 I body aches.
• 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.
• Travel outside of the state of Montana within the last two weeks.
• History of smoking or vaping within the last 2 years.
• Have known allergies or sensitivities to latex (natural rubber), metals, inks, sunscreens, deodorants, laundry detergents, cleansers, soaps, lotions, or common antibacterial agents, particularly, chlorhexidine gluconate (CHG), ethyl alcohol, and isopropyl alcohol or topical antibiotic ointments (e.g., Neosporin® or Polysporin®).
• Have experienced hives (raised welts) as a reaction to anything that contacted your skin, with the exception of plants known to cause reactions for most humans (e.g., poison oak or poison ivy).
• Be receiving any topical or systemic antibiotic medications during the 72-hour pre-test conditioning period or on the test day.
• Be receiving any steroids (including steroid medications used to treat asthma) other than for contraception, hormone therapy, or menopausal purposes during the 72-hour pre-test conditioning period or on the test day.
• Have any prosthetic joints anywhere in the body or any (pins, screws, plates, rods, or dental implants) anywhere in the body.
• Have any type of port (or po1iacath) or Peripherally Insetied Central Catheter (PICC).
• Be nursing a child.
• Be pregnant, or have plans to become pregnant or impregnate a sexual partner once you have consented to test in this study or during the test period.
• Any medical condition or use of any medications that, in the opinion of the Principal Investigator, or Consulting Physician should preclude patiicipation.
• Unwillingness to fulfill the performance requirements of the study.

Sponsors & Collaborators

• CAGE Bio Inc.: lead
• BioScience Laboratories, Inc.: collaborator

Study Sites (1)

Bioscience Laboratories, Inc.

Bozeman, Montana, 59718, United States

Location

Study Officials

• Senior Scientist

  BIOSCIENCE LAB ORA TORIES, INC.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 3, 2020
• Study Start: June 16, 2020
• Primary Completion: July 13, 2020
• Study Completion: July 28, 2020
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)