NCT02615912

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

September 28, 2016

Status Verified

September 1, 2016

Enrollment Period

1 month

First QC Date

October 30, 2015

Last Update Submit

September 26, 2016

Conditions

Dermatitis

Outcome Measures

Primary Outcomes (2)

  • Type of microbes present on skin after exposure to various surfactants

    Microbes will be identified by metagenomic sequencing

    4 days

  • Amount of microbes present on skin after exposure to various surfactants

    4 days

Study Arms (1)

Surfactant Exposure

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

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)

Interventions

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Subjects with visible skin disease, tattoos, skin condition, or abnormal skin color

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reliance Clinical Testing Service

Irving, Texas, 75062, United States

Location

Related Publications (6)

  • 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.

    PMID: 11525947BACKGROUND

  • 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.

    PMID: 24152302BACKGROUND

  • 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.

    PMID: 18007579BACKGROUND

  • 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.

    PMID: 19860898BACKGROUND

  • 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.

    PMID: 18652685BACKGROUND

  • 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.

    PMID: 19052515BACKGROUND

MeSH Terms

Conditions

Dermatitis

Interventions

sorbitan monopalmitatePowderslanpol 5Sodium Dodecyl SulfateWater

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical PreparationsDodecanolFatty AlcoholsAlcoholsOrganic ChemicalsAlkanesulfonatesAlkanesulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsLipidsHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Barry Reece, MBA

    RCTS, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2015

First Posted

November 26, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

September 28, 2016

Record last verified: 2016-09

Locations

US(1)