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Trial record 8 of 10556 for:    Anti-Infective Agents AND Bacterial

Analysis of the Effect of Antimicrobial Soap on Bacterial Survival

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ClinicalTrials.gov Identifier: NCT02012348
Recruitment Status : Completed
First Posted : December 16, 2013
Results First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
Colgate Palmolive
Information provided by (Responsible Party):
Richard Gallo, University of California, San Diego

Brief Summary:
This study will recruit up to 10 healthy volunteers. An avirulent strain of S. pyogenes will be applied to their forearms after washing each of their forearms with different types of soap, one with an antimicrobial compound, and the other without an antimicrobial compound. After several hours of incubation, the subject's forearms will be swabbed for bacteria. The forearms will then be cleansed with antibacterial soap and water followed by 70% ethanol. The bacterial swabs will be analyzed and compared between the different soaps that were used to cleanse each digit prior to the application of S. pyogenes. The investigator expects the number of bacteria surviving on the skin of forearms washed with antimicrobial soaps will be fewer than with control soap.

Condition or disease Intervention/treatment Phase
Survival of Bacteria on Skin After Using Different Soaps Other: Antibacterial soap with triclocarban Other: Antibacterial soap + benzalkonium chloride Other: Control soap Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Analysis of the Effect of Antimicrobial Soap on Bacterial Survival
Study Start Date : December 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Placebo Comparator: Control soap
Forearms of subjects in this arm will be washed with control (non-antibacterial) soap
Other: Control soap
Experimental: Antibacterial soap with triclocarban
The forearms of subjects in this group will be washed with antibacterial soap containing triclocarban
Other: Antibacterial soap with triclocarban
Active Comparator: Antibacterial soap + benzalkonium chloride
The forearms of subjects in this group will be washed with antibacterial soap containing benzalkonium chloride
Other: Antibacterial soap + benzalkonium chloride



Primary Outcome Measures :
  1. Relative GAS Survival [ Time Frame: 30 minutes post-bacteria application ]
    A skin swab will be used to measure the bacterial survival 30 minutes after bacteria application and soap treatment. The bacteria being applied and subsequently measured is Group A Streptococcus (GAS). The bacterial survival is expressed as abundance of GAS relative to abundance of other bacterial species isolated from the swab.


Secondary Outcome Measures :
  1. Relative GAS Survival [ Time Frame: 1 hour after bacteria application / 2 hours post washing ]
    A skin swab will be used to measure the bacterial survival 1 hour after bacteria application (2 hours post washing with soap). The bacteria being applied and subsequently measured is Group A Streptococcus (GAS). The bacterial survival is expressed as abundance of GAS relative to abundance of other bacterial species isolated from the swab.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Those who meet all of the following criteria are eligible for enrollment into the study:

  1. Age 18-60 years
  2. Male or female of any race and ethnicity
  3. Subject agrees to comply with study requirements.

Exclusion Criteria:

  1. Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study
  2. Dermatologic disease such as psoriasis or atopic dermatitis which may have inherently abnormal antimicrobial peptide levels
  3. Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
  4. Pregnant or nursing females
  5. Immunocompromised subjects (e.g., lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome), or with a history of active or malignant disease (excluding non-melanoma skin cancer) as determined by the participant's medical history.
  6. Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
  7. Subjects with significant concurrent medical condition(s) at screening that in the view of the investigator prohibits participation in the study (e.g., severe concurrent allergic disease, condition associated with malignancy, and condition associated with immunosuppression)
  8. Active viral or fungal skin infections at the target areas
  9. Are currently receiving lithium, antimalarials, or intramuscular gold now or within the last 4 weeks.
  10. Ongoing participation in an investigational drug trial
  11. Use of any oral or topical antibiotic during the study and up to one week prior to entering the study
  12. Use of any local topical medications less than one week prior to screening
  13. Use of any systemic immunosuppressive therapy less than four weeks prior to screening.
  14. Subjects with a history of or propensity to developing reactions after use of over the counter cleansers
  15. Subjects with diabetes
  16. Injured, broken skin that, per the investigator, may cause injury if exposed to low virulence GAS.

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): NCT02012348


Locations
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United States, California
UCSD Dermatology
San Diego, California, United States, 92122
Sponsors and Collaborators
University of California, San Diego
Colgate Palmolive

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Responsible Party: Richard Gallo, Chair, Division of Dermatology, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02012348     History of Changes
Other Study ID Numbers: UCSD 121622
First Posted: December 16, 2013    Key Record Dates
Results First Posted: October 3, 2019
Last Update Posted: October 3, 2019
Last Verified: September 2019
Keywords provided by Richard Gallo, University of California, San Diego:
bacteria survival, surfactants
Additional relevant MeSH terms:
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Benzalkonium Compounds
Triclocarban
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local