Clinical trial NCT01951352: Effects of Surfactants on the Innate Immune System
Official title: Effects of Surfactants on the Innate Immune System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: study
meant
individuals
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2013-09-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility 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. 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

Primary outcomes:
measure: Normalized LL-37 Expression
timeFrame: Baseline
measure: Normalized LL-37 Expression
timeFrame: 4 hours
measure: Normalized LL-37 Expression
timeFrame: 5 minutes
measure: Normalized LL-37 Expression
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Division of Dermatology
state: California
Study officials:
References: