Effect of Surfactants on the Skin Microbiome

NCT01951391 | Completed Results

• 1 other identifier: UCSD 111296
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Skin

Keywords

study; subjects

Outcome Measures

Primary Outcomes (1)

• Relative 16S Abundance - Control Soap

  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

  Baseline, 10 minutes, 6 hours, 24 hours

Secondary Outcomes (1)

• Relative Abundance of Staphylococcus Epidermidis of Intervention Arms

  Baseline, 6 hours

Study Arms (2)

Control Soap vs. Benzalkonium Chloride Soap

OTHER

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; Other: Benzalkonium Chloride Soap

Control Soap vs. Triclocarban Soap

OTHER

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; Other: Triclocarban Soap

Interventions

Control Hand Soap OTHER

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

Control Soap vs. Benzalkonium Chloride Soap; Control Soap vs. Triclocarban Soap

Benzalkonium Chloride Soap OTHER

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

Control Soap vs. Benzalkonium Chloride Soap

Triclocarban Soap OTHER

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

Control Soap vs. Triclocarban Soap

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Division of Dermatology

San Diego, California, 92122, United States

Location

Results Point of Contact

• Title: UCSD Dermatology Clinical Trials Manager
• Organization: UCSD Dermatology Clinical Trials

dermstudies@ucsd.edu

(858)657-8390

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: September 26, 2013
• Study Start: September 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 4, 2019
• Results First Posted: December 4, 2019

Record last verified: 2019-11

Locations

US (1)