Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Other: Cetaphil Restoraderm
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 3 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser. | Other: Standard of Care<br>* Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser.<br>* Other names: Johnson&Johnson;|
| Experimental: Cetaphil Restoraderm<br>Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser. | Other: Cetaphil Restoraderm<br>* Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2, 6, 12, 18, and 24 months | 
| Age at Onset of Eczema | Age of subject at onset of eczema | Baseline through Month 24 Follow-up | 
| Filaggrin Mutation Status | Filaggrin mutation status result | 6 month visit | 
| Transepidermal Water Loss (TEWL) | Transepidermal water loss (TEWL) to measure skin barrier function | 2 month, 6 month, and 12 month visits | 
| Skin Hydration (Skin Electrical Capacitance) | Determination of stratum corneum hydration from the dorsal forearm | 2 month, 6 month, and 12 month visits | 
| Skin pH | Skin pH, as measured using a pH probe | 2 month, 6 month, and 12 month visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atopic dermatitis, skin care