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

Primary Purpose

Dermatitis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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 (control)

About this trial

This is an interventional basic science trial for Dermatitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Reliance Clinical Testing Service

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Surfactant Exposure

Arm Description

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

Outcomes

Primary Outcome Measures

Type of microbes present on skin after exposure to various surfactants

Microbes will be identified by metagenomic sequencing

Amount of microbes present on skin after exposure to various surfactants

Secondary Outcome Measures

Full Information

NCT ID

NCT02615912

First Posted

October 30, 2015

Last Updated

September 26, 2016

Sponsor

Kimberly-Clark Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02615912

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kimberly-Clark Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Surfactant Exposure

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

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

Intervention Type

Other

Intervention Name(s)

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

Intervention Type

Other

Intervention Name(s)

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

Intervention Type

Other

Intervention Name(s)

Silwet* DA-63 (Momentive) 1.5%

Intervention Type

Other

Intervention Name(s)

Sodium lauryl sulfate (Sigma Aldrich) 1.0%

Intervention Type

Other

Intervention Name(s)

Water (control)

Primary Outcome Measure Information:

Title

Type of microbes present on skin after exposure to various surfactants

Description

Microbes will be identified by metagenomic sequencing

Time Frame

4 days

Title

Amount of microbes present on skin after exposure to various surfactants

Time Frame

4 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barry Reece, MBA

Organizational Affiliation

RCTS, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Reliance Clinical Testing Service

City

Irving

State/Province

Texas

ZIP/Postal Code

75062

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

11525947

Citation

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.

Results Reference

background

PubMed Identifier

24152302

Citation

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.

Results Reference

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PubMed Identifier

18007579

Citation

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.

Results Reference

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PubMed Identifier

19860898

Citation

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.

Results Reference

background

PubMed Identifier

18652685

Citation

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.

Results Reference

background

PubMed Identifier

19052515

Citation

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.

Results Reference

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

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