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Completed

NCT Number: NCT01375205

Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

1 day–3 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University Center for Health & Healing

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cetaphil Restoraderm

Other

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

Standard of care

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.

Other names: Johnson&Johnson

Primary outcomes

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

    Time frame: 12 months

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

Secondary outcomes

  1. Percentage of High Emollient Use

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

    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. Age at Onset of Eczema

    Time frame: Baseline through Month 24 Follow-up

    Age of subject at onset of eczema

  3. Filaggrin Mutation Status

    Time frame: 6 month visit

    Filaggrin mutation status result

  4. Transepidermal Water Loss (TEWL)

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

    Transepidermal water loss (TEWL) to measure skin barrier function

  5. Skin Hydration (Skin Electrical Capacitance)

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

    Determination of stratum corneum hydration from the dorsal forearm

  6. Skin pH

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

    Skin pH, as measured using a pH probe

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Galderma R&D

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Jun 17, 2011
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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