Evaluation of Chlorhexidine Gluconate Concentration on Skin of Human Subjects Following Multiple Application Times

NCT04235985 | Completed Phase 4 FDA Drug FDA Device

• 1 other identifier: #1906236-150B
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the amount of chlorhexidine gluconate (CHG) present on treated skin of human volunteers following different application times with a test material bathing system. The amount of recovered CHG that resides on the skin following each of the evaluated application times will be evaluated via high performance liquid chromatography with ultraviolet detection (HPLC-UV) and correlated with the MIC values determined separately.

Conditions

General Skin Cleansing

Outcome Measures

Primary Outcomes (1)

• Chlorhexidine skin levels

  To find out how much CHG is left on the skin with different application times

  range from 15 to 120 seconds

Study Arms (1)

All time points

OTHER

Combination Product: Chlorhexidine Gluconate with HUBS

Interventions

Chlorhexidine Gluconate with HUBS COMBINATION_PRODUCT

4% CHG soap will be applied to HUBS following manufacturers recommendation and applied to skin for different application times as dictated by the randomization of the marked sites on the forearm. Followed by a HUBS moistened with water.

All time points

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 must be at least 18 years of age and can be of either sex and of any race.
• Subjects must be able to read and understand English.
• Subjects must possess both forearms and have a minimum forearm length (wrist crease to elbow crease) of 8.25 inches \[21 cm\].
• Subjects must be in good general health (i.e., no current or recent severe illness) and have no medical diagnosis of mitral valve prolapse with heart murmur, congenital heart disease, an organ transplant, medicated or uncontrolled diabetes, hepatitis B or C, an immunocompromised condition such as AIDS (or HIV positive), lupus, fibromyalgia, ulcerative colitis, Crohn's disease, moderate to severe asthma (requiring daily use of medication), or medicated multiple sclerosis.

You may not qualify if:

• Participation in a clinical study within 7 days of participating in this study or current participation in another clinical study.
• Presence of tattoos, active skin rashes, dermatoses, or breaks in the skin of the forearms or hands. Subjects must also have no inflammatory skin conditions (such as atopic dermatitis / eczema, contact dermatitis, or psoriasis) anywhere on the body.
• Known allergies or sensitivities to latex (natural rubber), alcohols, sunscreens, deodorants, laundry detergents, inks, metals, topically-applied fragrances (e.g., colognes or perfumes), cleansers, soaps, lotions, or to common antibacterial agents particularly chlorhexidine gluconate (CHG).
• 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.
• Any prosthetic device or joint (e.g., pins, screws, plates, or rods) installed in the arms within the last 6 months.
• Any type of indwelling port or Peripherally-Inserted Central Catheter (PICC).
• Subject is pregnant, plans to become pregnant or impregnate a sexual partner within the pre-test and test periods of the study, or is nursing a child.
• Any medical condition or use of any medications that, in the opinion of the Principal Investigator or Consulting Physicians, should preclude participation.

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (1)

Bioscience Laboratories, Inc

Bozeman, Montana, 59718, United States

Location

MeSH Terms

Interventions

chlorhexidine gluconate

Study Officials

• Russell Griggs

  BSLI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: This is a cross-over design study where it will only be possible to mask the Outcomes Assessor
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Volunteer forearms will be marked with 6 test sites which will be randomly assigned a time point for the application.

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 22, 2020
• Study Start: January 23, 2020
• Primary Completion: April 2, 2020
• Study Completion: April 2, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)