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

Not Applicable

Completed

• Conditions: Dermatitis
• 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)

• Registration Number: NCT02615912
• Lead Sponsor: Kimberly-Clark Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-30
• Study Start: 2015-11
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-26
• Primary Completion: 2015-12
• Study Completion: 2016-02
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Reliance Clinical Testing Service; 🇺🇸 Irving, Texas, United States