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OpenTrials
Completed

NCT Number: NCT01951391

Effect of Surfactants on the Skin Microbiome

Up to 10 volunteers will be recruited to evaluate the microbial environment on their forearms. Following informed consent, bacterial swabs will be obtained at baseline from the forearms of all subjects. Their forearms will then be washed with one of the study cleansers. Subjects will then have their forearms swabbed for bacteria at the following time points: 10 minutes, 6 hours, and 24 hours after the wash. DNA will be extracted from all swabs and bacterial diversity evaluated by 16S pyrosequencing.

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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

The timeline for the patients will be as follows:

On Day 0, after being given a witnessed, written, informed consent, a medical history and a limited physical exam will be performed. If using certain topical products and medications that are not allowed during this study, patients may be asked to withhold them for the remainder of the study. The study doctor or study coordinator will explain which medications and activities are not allowed during this study. Baseline bacterial swabs from the bilateral volar forearms will be collected followed by application and rinsing of a hand wash with an antimicrobial compound (benzalkonium chloride or triclocarban) on the right forearm, and a cleanser without an antimicrobial compound (control) on the left forearm. 200 microliters of water/hand wash will be applied to the volar forearms and lather generated for 15 seconds using a gloved hand. The lather will be allowed to stay in contact with the skin for an additional 30 seconds. The total contact time will be 60 sec. The forearm will be rinsed with running tap water for 15 seconds, air-dried for 5 minutes and the skin surface will again be swabbed for bacteria 10 minutes after the wash. The same procedure will be repeated on the 2nd volar forearm with the opposing wash. Subjects will then have repeat skin swabs at 6 hours +/- 1 hour and at 24 hours +/- 6 hours after washing. Subjects will be instructed to avoid rigorous exercise/swimming, significant sun exposure (i.e. sunbathing), cleaning the forearms with other antibacterial products, and showering during these 24 hours.

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
  • Are currently receiving lithium, antimalarials, or intramuscular gold now or within the last 4 weeks.
  • 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
  • Subjects with diabetes

Treatment and study plan

Control Hand Soap

Other

Commercially available soap will be used to wash the subject's forearms

Benzalkonium Chloride Soap

Other

Commercially available soap containing benzalkonium chloride will be used to wash the subject's forearms

Triclocarban Soap

Other

Commercially available soap containing triclocarban will be used to wash the subject's forearms

Primary outcomes

  1. Relative 16S Abundance - Control Soap

    Time frame: Baseline, 10 minutes, 6 hours, 24 hours

    Total bacterial DNA abundance at baseline (relative to baseline), prior to washing with control soap (softsoap aquarium series hand soap) as measured by qPCR of 16S RNA

Secondary outcomes

  1. Relative Abundance of Staphylococcus Epidermidis of Intervention Arms

    Time frame: Baseline, 6 hours

    Total bacterial DNA abundance of S. epidermidis (relative to baseline) at baseline and 6 hours, before washing with any soap as measured by qPCR of 16S RNA

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
Dec 4, 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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