A Single-Center, Exploratory Study to Analyze the Dynamics of Skin Microflora Following Exposure to Surfactants
Sponsor
Kimberly-Clark Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02615912
Collaborator
(none)
24
1
1
3
7.9
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Single-Center, Exploratory Study to Analyze the Dynamics of Skin Microflora Following Exposure to Surfactants
Study Start Date
:
Nov 1, 2015
Actual Primary Completion Date
:
Dec 1, 2015
Actual Study Completion Date
:
Feb 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
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)
|
Outcome Measures
Primary Outcome Measures
- Type of microbes present on skin after exposure to various surfactants [4 days]
Microbes will be identified by metagenomic sequencing
- Amount of microbes present on skin after exposure to various surfactants [4 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Reliance Clinical Testing Service | Irving | Texas | United States | 75062 |
Sponsors and Collaborators
- Kimberly-Clark Corporation
Investigators
- Principal Investigator: Barry Reece, MBA, RCTS, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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, Dowd SE. A rapid molecular method for characterising bacterial bioburden in chronic wounds. J Wound Care. 2008 Dec;17(12):513-6. Review.
- 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.
Responsible Party:
Kimberly-Clark Corporation
ClinicalTrials.gov Identifier:
NCT02615912
Other Study ID Numbers:
- 500-15-0004
First Posted:
Nov 26, 2015
Last Update Posted:
Sep 28, 2016
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms: