Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants

NCT ID: NCT01375205

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2015-11-30

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

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

Cetaphil Restoraderm

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

Group Type: EXPERIMENTAL

Cetaphil Restoraderm

Intervention Type: OTHER

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

Interventions

Cetaphil Restoraderm

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

Johnson&Johnson

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 3 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Eric Simpson

M.D., M.C.R.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Simpson, MD, MCR

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University Center for Health & Healing

Portland, Oregon, United States

Countries

United States

Other Identifiers

Galderma Cetaphil Restoraderm

Identifier Type: -

Identifier Source: org_study_id