Effect of Surfactants on the Skin Microbiome

• ClinicalTrials.gov Identifier: NCT01951391
• Recruitment Status: Completed
• First Posted: September 26, 2013
• Results First Posted: December 4, 2019
• Last Update Posted: December 4, 2019
• Sponsor: University of California, San Diego
• Information provided by (Responsible Party): Tissa Hata, MD, University of California, San Diego

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy Skin	Other: Control Hand Soap; Other: Benzalkonium Chloride Soap; Other: Triclocarban Soap	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Effect of Surfactants on the Skin Microbiome
• Study Start Date: September 2013
• Actual Primary Completion Date: January 2015
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
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.	Other: Control Hand Soap; Commercially available soap will be used to wash the subject's forearms; Other: Benzalkonium Chloride Soap; 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.	Other: Control Hand Soap; Commercially available soap will be used to wash the subject's forearms; Other: Triclocarban Soap; Commercially available soap containing triclocarban will be used to wash the subject's forearms

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, California

UCSD Division of Dermatology

San Diego, California, United States, 92122

Sponsors and Collaborators

University of California, San Diego

More Information

• Responsible Party: Tissa Hata, MD, MD, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT01951391
• Other Study ID Numbers: UCSD 111296
• First Posted: September 26, 2013
• Results First Posted: December 4, 2019
• Last Update Posted: December 4, 2019
• Last Verified: November 2019

Keywords provided by Tissa Hata, MD, University of California, San Diego:

study; subjects

Additional relevant MeSH terms:

Benzalkonium Compounds; Triclocarban; Anti-Infective Agents, Local; Anti-Infective Agents