Atopic Dermatitis Clinical Trial
Official title:
A Randomized Pilot Trial Comparing Cetaphil® Restoraderm® System and Standard Skin Care in Infants at Risk for Atopic Dermatitis
The goal of this study is to determine what effect Cetaphil® Restoraderm® system has on babies' skin versus Johnson & Johnson baby lotion and skin cleanser.
Subjects will randomly be divided into a group using Cetaphil® Restoraderm® system or a group
using Johnson & Johnson baby lotion and skin cleanser . At 3, 6, and 12 months non-invasive
measurements of barrier function will be used to test the babies' skin. The procedures are as
follows:
- Transepidermal loss (TEWL - measures the water loss from the skin)
- Skin electrical capacitance (measures how much water stays in the top layer of skin)
- Skin pH (measures level of pH)
- Skin microbiome analysis (skin swabs to check genetic code of skin bacteria)
- Lipidomic and natural moisturizing factor analysis (measures lipids (oils) in the top
layer of skin)
Both groups will be reminded to follow the instructions about general good skin care of
infants. Subjects will be asked if they agree to provide a saliva sample. If yes, a saliva
sample will be collected from the inside of the infant's cheek at the 6 month visit and will
be shipped to the laboratory of Dr. Irwin McLean at the University of Dundee, where it will
be tested for gene defects in the skin barrier that might trigger the development of eczema.
Defects in the gene called filaggrin have been shown to increase the risk of developing
eczema. The samples will be identified by a code to protect your infant's identity. The
saliva samples will be stored only for this study, and then the sample will be destroyed.
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