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

Kimberly-Clark

Status: Completed

Conditions: Dermatitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02615912

500-15-0004

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Surfactant Exposure

Other group

Description:

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

Treatment:

Other: Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5%

Other: Water (control)

Other: PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5%

Other: Lauryl glucoside (Plantacare® 1200UP, BASF) 1.5%

Other: Silwet* DA-63 (Momentive) 1.5%

Other: Sodium lauryl sulfate (Sigma Aldrich) 1.0%