Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants

Oregon Health and Science University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

100

Conditions

Atopic Dermatitis

Interventions

Cetaphil RestoradermOTHER

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

Standard of CareOTHER

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

Eligibility

Sex: ALLMin age: 1 DayMax age: 3 Weeks

Medical Language ↔ Plain English

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

Locations (1)

Oregon Health & Science University Center for Health & Healing

Portland, Oregon, United States

Outcomes

Primary Outcomes

Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months

Percentage of cumulative Atopic Dermatitis diagnosed by a blinded investigator at 12 months

Time frame: 12 months

Secondary Outcomes

Percentage of High Emollient Use

Patient-reported adherence to the emollient regimen in the intervention group and the treatment group. High emollient use was defined as applying the intervention or control emollient five or more days per week.

Time frame: 2, 6, 12, 18, and 24 months

Age at Onset of Eczema

Age of subject at onset of eczema

Time frame: Baseline through Month 24 Follow-up

Filaggrin Mutation Status

Filaggrin mutation status result

Time frame: 6 month visit

Transepidermal Water Loss (TEWL)

Transepidermal water loss (TEWL) to measure skin barrier function

Time frame: 2 month, 6 month, and 12 month visits

Skin Hydration (Skin Electrical Capacitance)

Determination of stratum corneum hydration from the dorsal forearm

Time frame: 2 month, 6 month, and 12 month visits

Skin pH

Skin pH, as measured using a pH probe

Time frame: 2 month, 6 month, and 12 month visits

Data from ClinicalTrials.gov

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