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

Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615912
• Other study ID #: 500-15-0004
• Status: Completed
• Phase: N/A
• First received: October 30, 2015
• Last updated: September 26, 2016
• Start date: November 2015
• Est. completion date: February 2016

Study information

• Verified date: September 2016
• Source: Kimberly-Clark Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dermatitis

Intervention

Other:
• 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)

Locations

Country	Name	City	State
United States	Reliance Clinical Testing Service	Irving	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Kimberly-Clark Corporation

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View Citation

Löffler 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. — View Citation

Törmä 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. Epub 2007 Nov 15. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type of microbes present on skin after exposure to various surfactants	Microbes will be identified by metagenomic sequencing	4 days	No
Primary	Amount of microbes present on skin after exposure to various surfactants		4 days	No