- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01951352
Effects of Surfactants on the Innate Immune System
September 9, 2019 updated by: Tissa Hata, MD, University of California, San Diego
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.
Study Overview
Detailed Description
We will use tape-stripping methods to determine the level of antimicrobial peptides (specifically LL-37) present on the human skin after washing with different commercially available hand soaps.
First we will do a baseline tape-stripping procedure to measure the amount of LL-37 on subjects' forearms.
Tape stripping involves applying small, round tapes (CuDerm, Dallas, TX) to the skin, massaging them for about 10 second, and then removing them.
This process is repeated 9 times for each tape.
After doing baseline tape stripping samples, each participant's forearms will be washed with a different soap.
The soap will be rinsed off, and the skin allowed to dry.
After the forearms are dry (about 5 minutes later), repeat tape-stripping will be performed.
This tape-stripping process will then be repeated 4 hours later, and then 24 hours later as well.
Results of the LL-37 expression at each time point will then be compared between soaps.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92122
- UCSD Division of Dermatology
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Soap recipient
The forearms of all subjects will eventually be washed with the same soaps.
There is only one arm for this study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Normalized LL-37 Expression
Time Frame: Baseline
|
LL-37 expression was measured using tape-stripping methods and expressed relative to baseline.
|
Baseline
|
Normalized LL-37 Expression
Time Frame: 4 hours
|
LL-37 was measured using tape-stripping methods and is expressed relative to baseline levels
|
4 hours
|
Normalized LL-37 Expression
Time Frame: 5 minutes
|
LL-37 expression was measured using tape-stripping methods and expressed relative to baseline.
|
5 minutes
|
Normalized LL-37 Expression
Time Frame: 24 hours
|
LL-37 expression was measured using tape-stripping methods and expressed relative to baseline.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
September 23, 2013
First Submitted That Met QC Criteria
September 25, 2013
First Posted (Estimate)
September 26, 2013
Study Record Updates
Last Update Posted (Actual)
October 2, 2019
Last Update Submitted That Met QC Criteria
September 9, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UCSD 111295
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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