Effects of Surfactants on the Innate Immune System

NCT01951352 | Completed Results

• 1 other identifier: UCSD 111295
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

study; meant; individuals

Outcome Measures

Primary Outcomes (4)

• Normalized LL-37 Expression

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

  Baseline

• Normalized LL-37 Expression

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

  4 hours

• Normalized LL-37 Expression

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

  5 minutes

• Normalized LL-37 Expression

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

  24 hours

Study Arms (1)

Soap recipient

EXPERIMENTAL

The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study.

Other: Soap

Interventions

Soap OTHER

Soap recipient

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
• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Division of Dermatology

San Diego, California, 92122, United States

Location

MeSH Terms

Interventions

Soaps

Intervention Hierarchy (Ancestors)

Detergents; Surface-Active Agents; Specialty Uses of Chemicals; Chemical Actions and Uses; Household Products; Technology, Industry, and Agriculture

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: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• 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: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 2, 2019
• Results First Posted: October 2, 2019

Record last verified: 2019-09

Locations

US (1)