Clinical trial NCT01375205: Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants
Official title: A Randomized Pilot Trial Comparing Cetaphil® Restoraderm® System and Standard Skin Care in Infants at Risk for Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
skin care
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Galderma R&D
First posted: 2011-06-17
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of High Emollient Use
timeFrame: 2, 6, 12, 18, and 24 months
measure: Age at Onset of Eczema
timeFrame: Baseline through Month 24 Follow-up
measure: Filaggrin Mutation Status
timeFrame: 6 month visit
measure: Transepidermal Water Loss (TEWL)
timeFrame: 2 month, 6 month, and 12 month visits
measure: Skin Hydration (Skin Electrical Capacitance)
timeFrame: 2 month, 6 month, and 12 month visits
measure: Skin pH
timeFrame: 2 month, 6 month, and 12 month visits
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University Center for Health & Healing
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Eric Simpson, MD, MCR
role: PRINCIPAL_INVESTIGATOR
References: