N/A
N=10
Effects of Surfactants on the Innate Immune System
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01951352 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Normalized LL-37 Expression — 100 percentage of baseline
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Soap (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Normalized LL-37 Expression |
87 | — |
| PRIMARY Normalized LL-37 Expression |
87 | — |
| PRIMARY Normalized LL-37 Expression |
87 | — |
| PRIMARY Normalized LL-37 Expression |
87 | — |
Summary
In this study we will test the ability of different commercially available hand soaps to effect the amount of anti-microbial peptides present on the surface of the human skin after washing with these soaps. Based on our experiments on pig skin, we expect the amount of antimicrobial peptide expression to decrease after using these different soaps.
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
- Previous participation in this study
- 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
- History of allergy to adhesive tape
Data sourced from ClinicalTrials.gov (NCT01951352). 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.