Infant Fecal Insult Study

Kimberly-Clark

Status: Completed

Conditions: Dermatitis

Treatments: Other: Phosphate Buffered Saline; Other: Artificial Fecal Insult

Study type: Interventional

Funder types: Industry

Identifiers

NCT02979210

500-16-0003

Details and patient eligibility

About

The rationale for the study is to better understand the dynamics of skin microflora following skin barrier disruption in an adult dermatitis model. The results from this study will provide insights in the complex interaction between skin microbiome and epidermis under normal and disease conditions

Enrollment: 24 patients

Sex: Female

Ages: 18 to 40 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

Artificial Fecal Insult

Other group

Description:

protease/bile acid cocktail 200 microliters (1500 µg/ml trypsin/chymotrypsin protease mixture, 6.5 mg/ml cholic acid sodium, 6.2 mg/ml deoxycholic acid sodium, and 3.1 mg/ml chenodeoxycholic acid sodium in phosphate buffered saline)

Treatment:

Other: Phosphate Buffered Saline

Other: Artificial Fecal Insult