Effects of Surfactants on the Innate Immune System

NCT ID: NCT01951352

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Soap recipient

The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study.

Group Type: EXPERIMENTAL

Soap

Intervention Type: OTHER

Interventions

Soap

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Tissa Hata, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UCSD Division of Dermatology

San Diego, California, United States

Countries

United States

Other Identifiers

UCSD 111295

Identifier Type: -

Identifier Source: org_study_id