Clinical Evaluation of the Residual Antimicrobial Activity

Bacterial Overgrowth Clinical Trial

Official title:

Clinical Evaluation of the Residual Antimicrobial Activity of One Test Product Based on the ASTM E2752 Test Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04495920
• Other study ID #: 2005367-150
• Status: Completed
• Phase: Early Phase 1
• Start date: June 16, 2020
• Est. completion date: July 28, 2020

Study information

• Verified date: August 2020
• Source: CAGE Bio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

At least twelve test subjects (aged 18-65 years), with healthy skin will be used in this study, and will use the test product on one arm, and have the other arm untreated as the negative control. The test sites on both forearms will be inoculated with suspensions containing Staphylococcus au re us (A TCC #653 8), immediately after the 30 minute product drying time, and at approximately 2 hours and 4 hours following test material applications. The test sites will be sampled using the cup scrub procedure approximately 20 minutes following each inoculation. The log 10 microbial recoveries of treated versus untreated sites will be the basis for assessing the residual antimicrobial effectiveness of the test product.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 28, 2020
• Est. primary completion date: July 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Subjects may be of either sex, between the ages of 18 and 65 years, and of any race.

2. Subjects must possess both forearms.

3. 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

4. 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.

5. Subjects must have read and signed an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and List of Restricted Products.

Exclusion Criteria:

1. Participation in a clinical study in the past 7 days or current participation in another clinical study.

2. 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.

3. 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.

4. Travel outside of the state of Montana within the last two weeks.

5. History of smoking or vaping within the last 2 years.

6. 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®).

7. 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).

8. Be receiving any topical or systemic antibiotic medications during the 72-hour pre-test conditioning period or on the test day.

9. 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.

10. Have any prosthetic joints anywhere in the body or any (pins, screws, plates, rods, or dental implants) anywhere in the body.

11. Have any type of port (or po1iacath) or Peripherally Insetied Central Catheter (PICC).

12. Be nursing a child.

13. 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.

14. Any medical condition or use of any medications that, in the opinion of the Principal Investigator, or Consulting Physician should preclude patiicipation.

15. Unwillingness to fulfill the performance requirements of the study.

Related Conditions & MeSH terms

• Bacterial Overgrowth

Intervention

Drug:
• CGB-S-100
Alcohol and choline geranate

Locations

Country	Name	City	State
United States	Bioscience Laboratories, Inc.	Bozeman	Montana

Sponsors (2)

Lead Sponsor	Collaborator
CAGE Bio Inc.	BIOSCIENCE LABORATORIES, INC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant Log 10 Microbial Change 4 hours post application		4 hours