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Completed

NCT Number: NCT01951352

Effects of Surfactants on the Innate Immune System

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSD Division of Dermatology

San Diego, California, 92122, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Soap

Other

Primary outcomes

  1. Normalized LL-37 Expression

    Time frame: Baseline

    LL-37 expression was measured using tape-stripping methods and expressed relative to baseline.

  2. Normalized LL-37 Expression

    Time frame: 4 hours

    LL-37 was measured using tape-stripping methods and is expressed relative to baseline levels

  3. Normalized LL-37 Expression

    Time frame: 5 minutes

    LL-37 expression was measured using tape-stripping methods and expressed relative to baseline.

  4. Normalized LL-37 Expression

    Time frame: 24 hours

    LL-37 expression was measured using tape-stripping methods and expressed relative to baseline.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 26, 2013
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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