Effect of Surfactants on the Skin Microbiome

NCT ID: NCT01951391

Last Updated: 2019-12-04

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

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.

Detailed Description

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.

Conditions

Healthy Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control Soap vs. Benzalkonium Chloride Soap

Each subject's will have one forearm washed with a control soap and then the other forearm will be washed with benzalkonium chloride soap. The control forearm will be swabbed for bacteria at baseline, 10 minutes, 6 hours, and 24 hours. The benzalkonium chloride forearm will be swabbed at baseline and 6 hours.

Group Type: OTHER

Control Hand Soap

Intervention Type: OTHER

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

Benzalkonium Chloride Soap

Intervention Type: OTHER

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

Control Soap vs. Triclocarban Soap

Each subject's will have one forearm washed with a control soap and then the other forearm will be washed with triclocarban soap. The control forearm will be swabbed for bacteria at baseline, 10 minutes, 6 hours, and 24 hours. The triclocarban forearm will be swabbed at baseline and 6 hours.

Group Type: OTHER

Control Hand Soap

Intervention Type: OTHER

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

Triclocarban Soap

Intervention Type: OTHER

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

Interventions

Control Hand Soap

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

Intervention Type: OTHER

Benzalkonium Chloride Soap

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

Intervention Type: OTHER

Triclocarban Soap

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

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

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. Subjects with diabetes

• 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 111296

Identifier Type: -

Identifier Source: org_study_id