A Single-Center, Exploratory Study to Analyze the Dynamics of Skin Microflora Following Exposure to Surfactants

NCT ID: NCT02615912

Last Updated: 2016-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-02-29

Brief Summary

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The purpose of this study is to understand the changes in skin microflora, skin barrier function, and skin biochemical constituents in response to direct contact with model surfactants used in personal care articles. The results from this study will provide insights into the complex interaction between the skin microbiome and the epidermis after exposure to surfactants.

Detailed Description

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Conditions

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Dermatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Surfactant Exposure

PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5% Lauryl glucoside (Plantacare® 1200UP, BASF) 1.5% Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5% Silwet\* DA-63 (Momentive) 1.5% Sodium lauryl sulfate (Sigma Aldrich) 1.0% Water

Group Type OTHER

PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5%

Intervention Type OTHER

Lauryl glucoside (Plantacare® 1200UP, BASF) 1.5%

Intervention Type OTHER

Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5%

Intervention Type OTHER

Silwet* DA-63 (Momentive) 1.5%

Intervention Type OTHER

Sodium lauryl sulfate (Sigma Aldrich) 1.0%

Intervention Type OTHER

Water (control)

Intervention Type OTHER

Interventions

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PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5%

Intervention Type OTHER

Lauryl glucoside (Plantacare® 1200UP, BASF) 1.5%

Intervention Type OTHER

Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5%

Intervention Type OTHER

Silwet* DA-63 (Momentive) 1.5%

Intervention Type OTHER

Sodium lauryl sulfate (Sigma Aldrich) 1.0%

Intervention Type OTHER

Water (control)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy Subjects with Fitzpatrick Skin Types I, II or III

Exclusion Criteria

* Subjects with visible skin disease, tattoos, skin condition, or abnormal skin color
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kimberly-Clark Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barry Reece, MBA

Role: PRINCIPAL_INVESTIGATOR

RCTS, Inc.

Locations

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Reliance Clinical Testing Service

Irving, Texas, United States

Site Status

Countries

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United States

References

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Loffler H, Pirker C, Aramaki J, Frosch PJ, Happle R, Effendy I. Evaluation of skin susceptibility to irritancy by routine patch testing with sodium lauryl sulfate. Eur J Dermatol. 2001 Sep-Oct;11(5):416-9.

Reference Type BACKGROUND
PMID: 11525947 (View on PubMed)

Hoffman DR, Kroll LM, Basehoar A, Reece B, Cunningham CT, Koenig DW. Immediate and extended effects of sodium lauryl sulphate exposure on stratum corneum natural moisturizing factor. Int J Cosmet Sci. 2014 Feb;36(1):93-101. doi: 10.1111/ics.12101. Epub 2013 Nov 20.

Reference Type BACKGROUND
PMID: 24152302 (View on PubMed)

Torma H, Lindberg M, Berne B. Skin barrier disruption by sodium lauryl sulfate-exposure alters the expressions of involucrin, transglutaminase 1, profilaggrin, and kallikreins during the repair phase in human skin in vivo. J Invest Dermatol. 2008 May;128(5):1212-9. doi: 10.1038/sj.jid.5701170. Epub 2007 Nov 15.

Reference Type BACKGROUND
PMID: 18007579 (View on PubMed)

Wolcott RD, Gontcharova V, Sun Y, Dowd SE. Evaluation of the bacterial diversity among and within individual venous leg ulcers using bacterial tag-encoded FLX and titanium amplicon pyrosequencing and metagenomic approaches. BMC Microbiol. 2009 Oct 27;9:226. doi: 10.1186/1471-2180-9-226.

Reference Type BACKGROUND
PMID: 19860898 (View on PubMed)

Dowd SE, Callaway TR, Wolcott RD, Sun Y, McKeehan T, Hagevoort RG, Edrington TS. Evaluation of the bacterial diversity in the feces of cattle using 16S rDNA bacterial tag-encoded FLX amplicon pyrosequencing (bTEFAP). BMC Microbiol. 2008 Jul 24;8:125. doi: 10.1186/1471-2180-8-125.

Reference Type BACKGROUND
PMID: 18652685 (View on PubMed)

Wolcott RD, Dowd SE. A rapid molecular method for characterising bacterial bioburden in chronic wounds. J Wound Care. 2008 Dec;17(12):513-6. doi: 10.12968/jowc.2008.17.12.31769.

Reference Type BACKGROUND
PMID: 19052515 (View on PubMed)

Other Identifiers

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500-15-0004

Identifier Type: -

Identifier Source: org_study_id

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