Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Other: Standard of Care; Other: Cetaphil Restoraderm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01375205

Galderma Cetaphil Restoraderm

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 1 day to 3 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants up to three weeks of age born to mothers aged 18-45 years will be recruited for this study.
• Infants must have a family history of asthma, eczema, or hayfever in at least one first-degree relative and be in otherwise good overall health.

Exclusion criteria

• Preterm birth defined as birth prior to 37 weeks gestation
• Major congenital anomaly
• Hydrops fetalis
• Significant dermatitis at birth not including seborrheic dermatitis on the scalp ("cradle cap")
• Any immunodeficiency disorder
• Any severe genetic skin disorder
• Any other serious condition that would make the use of emollients inadvisable
• Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention or in whom assessing the outcomes may be masked by the underlying problem or practically very difficult to assess

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

Subjects will apply Johnson\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\&Johnson cleanser.

Treatment:

Other: Standard of Care

Cetaphil Restoraderm

Experimental group

Description:

Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.

Treatment:

Other: Cetaphil Restoraderm