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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04235985
Recruitment Status : Not yet recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB

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.

Condition or disease Intervention/treatment Phase
General Skin Cleansing Combination Product: Chlorhexidine Gluconate with HUBS Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Volunteer forearms will be marked with 6 test sites which will be randomly assigned a time point for the application.
Masking: None (Open Label)
Masking Description: This is a cross-over design study where it will only be possible to mask the Outcomes Assessor
Primary Purpose: Other
Official Title: Evaluation of Chlorhexidine Gluconate Concentration on Skin of Human Subjects Following
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020


Arm Intervention/treatment
All time points Combination Product: Chlorhexidine Gluconate with HUBS
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.




Primary Outcome Measures :
  1. Chlorhexidine skin levels [ Time Frame: range from 15 to 120 seconds ]
    To find out how much CHG is left on the skin with different application times



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04235985


Contacts
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Contact: Caroline Scott +44 161 621 3936 caroline.scott@molnlycke.com

Sponsors and Collaborators
Molnlycke Health Care AB
Investigators
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Principal Investigator: Russell Griggs BSLI

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Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT04235985    
Other Study ID Numbers: #1906236-150B
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents