Effects of Surfactants on the Innate Immune System

• Sponsor: University of California, San Diego (Other)
• Overall Status: Completed
• CT.gov ID: NCT01951352
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 27
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Soap	N/A

Detailed Description

We will use tape-stripping methods to determine the level of antimicrobial peptides (specifically LL-37) present on the human skin after washing with different commercially available hand soaps. First we will do a baseline tape-stripping procedure to measure the amount of LL-37 on subjects' forearms. Tape stripping involves applying small, round tapes (CuDerm, Dallas, TX) to the skin, massaging them for about 10 second, and then removing them. This process is repeated 9 times for each tape. After doing baseline tape stripping samples, each participant's forearms will be washed with a different soap. The soap will be rinsed off, and the skin allowed to dry. After the forearms are dry (about 5 minutes later), repeat tape-stripping will be performed. This tape-stripping process will then be repeated 4 hours later, and then 24 hours later as well. Results of the LL-37 expression at each time point will then be compared between soaps.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Effects of Surfactants on the Innate Immune System
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Soap recipient The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study.	Other: Soap

Outcome Measures

Primary Outcome Measures

1. Normalized LL-37 Expression [Baseline]

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

2. Normalized LL-37 Expression [4 hours]

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

3. Normalized LL-37 Expression [5 minutes]

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

4. Normalized LL-37 Expression [24 hours]

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

Eligibility Criteria

Criteria

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

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. Previous participation in this study

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. History of allergy to adhesive tape

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD Division of Dermatology	San Diego	California	United States	92122

Sponsors and Collaborators

• University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tissa Hata, MD, MD, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT01951352
• Other Study ID Numbers: UCSD 111295
• First Posted: Sep 26, 2013
• Last Update Posted: Oct 2, 2019
• Last Verified: Sep 1, 2019

• Keywords provided by Tissa Hata, MD, MD, University of California, San Diego: study; meant; individuals

Study Results

Participant Flow

Arm/Group Title	Soap Recipient
Arm/Group Description	The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study. Soap
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Soap Recipient
Arm/Group Description	The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study. Soap
Overall Participants	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.6 (7.4)
Sex: Female, Male (Count of Participants)
Female	2 20%
Male	8 80%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 10%
Not Hispanic or Latino	9 90%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Normalized LL-37 Expression
Description	LL-37 expression was measured using tape-stripping methods and expressed relative to baseline.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Soap Recipient
Arm/Group Description	The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study. Soap
Measure Participants	10
Mean (Standard Deviation) [percentage of baseline]	100 (0)

2. Primary Outcome

Title	Normalized LL-37 Expression
Description	LL-37 was measured using tape-stripping methods and is expressed relative to baseline levels
Time Frame	4 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Soap Recipient
Arm/Group Description	The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study. Soap
Measure Participants	10
Mean (Standard Deviation) [percentage of baseline]	82 (10)

3. Primary Outcome

Title	Normalized LL-37 Expression
Description	LL-37 expression was measured using tape-stripping methods and expressed relative to baseline.
Time Frame	5 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Soap Recipient
Arm/Group Description	The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study. Soap
Measure Participants	10
Mean (Standard Deviation) [percentage of baseline]	77 (30)

4. Primary Outcome

Title	Normalized LL-37 Expression
Description	LL-37 expression was measured using tape-stripping methods and expressed relative to baseline.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Soap Recipient
Arm/Group Description	The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study. Soap
Measure Participants	10
Mean (Standard Deviation) [percentage of baseline]	87 (20)

Adverse Events

Arm/Group Title	Soap Recipient
Arm/Group Description	The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study. Soap
All Cause Mortality
	Soap Recipient
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Soap Recipient
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Soap Recipient
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.