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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

Interventions

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

Arms, Groups and Cohorts

  • Other: 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

Clinical Trial Outcome Measures

Primary Measures

  • Type of microbes present on skin after exposure to various surfactants
    • Time Frame: 4 days
    • Microbes will be identified by metagenomic sequencing
  • Amount of microbes present on skin after exposure to various surfactants
    • Time Frame: 4 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Kimberly-Clark Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Barry Reece, MBA, Principal Investigator, RCTS, Inc.

References

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.

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.

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.

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.

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.

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.

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