NCT01375205

Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants

A Randomized Pilot Trial Comparing Cetaphil® Restoraderm® System and Standard Skin Care in Infants at Risk for Atopic Dermatitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 1 Day – 3 Weeks
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
OTHER	Cetaphil Restoraderm	Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.
OTHER	Standard of Care	Subjects will apply Johnson\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\&Johnson cleanser.

Timeline

• Start date: 2011-06-01
• Primary completion: 2014-10-01
• Completion: 2015-11-01
• First posted: 2011-06-17
• Last updated: 2020-02-12
• Results posted: 2019-04-12

Locations

1 site across 1 country: United States