N/A
N=30
Analysis of the Effect of Antimicrobial Soap on Bacterial Survival
Survival of Bacteria on Skin After Using Different Soaps
Bottom Line
View on ClinicalTrials.gov: NCT02012348 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Relative GAS Survival — 100; 75; 90 percentage overall bacterial abundance
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Antibacterial soap with triclocarban (Other); Antibacterial soap + benzalkonium chloride (Other); Control soap (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative GAS Survival |
100; 86.7; 61.7 | — |
| SECONDARY Relative GAS Survival |
100; 86.7; 61.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
Those who meet all of the following criteria are eligible for enrollment into the study:
- Age 18-60 years
- Male or female of any race and ethnicity
- Subject agrees to comply with study requirements.
Exclusion Criteria
- Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Dermatologic disease such as psoriasis or atopic dermatitis which may have inherently abnormal antimicrobial peptide levels
- Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
- Pregnant or nursing females
- 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.
- 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
- 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)
- Active viral or fungal skin infections at the target areas
- Are currently receiving lithium, antimalarials, or intramuscular gold now or within the last 4 weeks.
- Ongoing participation in an investigational drug trial
- Use of any oral or topical antibiotic during the study and up to one week prior to entering the study
- Use of any local topical medications less than one week prior to screening
- Use of any systemic immunosuppressive therapy less than four weeks prior to screening.
- Subjects with a history of or propensity to developing reactions after use of over the counter cleansers
- Subjects with diabetes
- Injured, broken skin that, per the investigator, may cause injury if exposed to low virulence GAS.
Data sourced from ClinicalTrials.gov (NCT02012348). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.