Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01375205
• Other study ID #: Galderma Cetaphil Restoraderm
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: November 2015

Study information

• Verified date: January 2020
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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

Locations

Country	Name	City	State
United States	Oregon Health & Science University Center for Health & Healing	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Galderma

Country where clinical trial is conducted

United States, 

Outcome

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