Trial Outcomes & Findings for Effects of Surfactants on the Innate Immune System (NCT NCT01951352)

NCT ID: NCT01951352

Last Updated: 2019-10-02

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2019-10-02

Participant Flow

Participant milestones

Measure	Soap Recipient The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study. Soap
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Surfactants on the Innate Immune System

Baseline characteristics by cohort

Measure	Soap Recipient n=10 Participants The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study. Soap
Age, Continuous	31.6 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Soap Recipient n=10 Participants The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study. Soap
Normalized LL-37 Expression	100 percentage of baseline Standard Deviation 0

PRIMARY outcome

Timeframe: 4 hours

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

Outcome measures

Measure	Soap Recipient n=10 Participants The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study. Soap
Normalized LL-37 Expression	82 percentage of baseline Standard Deviation 10

PRIMARY outcome

Timeframe: 5 minutes

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

Outcome measures

Measure	Soap Recipient n=10 Participants The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study. Soap
Normalized LL-37 Expression	77 percentage of baseline Standard Deviation 30

PRIMARY outcome

Timeframe: 24 hours

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

Outcome measures

Measure	Soap Recipient n=10 Participants The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study. Soap
Normalized LL-37 Expression	87 percentage of baseline Standard Deviation 20

Adverse Events

Soap Recipient

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

UCSD Dermatology Clinical Trials Manager

UCSD Dermatology Clinical Trials

Phone: (858)657-8390

Email: dermstudies@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place