Effects of Surfactants on the Innate Immune System



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 60
Updated:10/19/2013
Start Date:September 2013
Contact:Aimee Two, MD
Email:ucsddermstudies@gmail.com
Phone:858-657-8390

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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.


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.

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. Previous participation in this study

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. History of allergy to adhesive tape
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San Diego, California 92122
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