Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Galderma
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01375205
First received: June 15, 2011
Last updated: June 20, 2011
Last verified: June 2011

June 15, 2011
June 20, 2011
June 2011
July 2013   (final data collection date for primary outcome measure)
Incidence of atopic dermatitis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The primary outcome will be the cumulative incidence of AD at one year.
Same as current
Complete list of historical versions of study NCT01375205 on ClinicalTrials.gov Archive Site
Effects on infants' skin barrier [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary outcomes include adherence measures, time to disease onset, adverse events, and skin barrier function in a sub-set of subjects.
Same as current
Not Provided
Not Provided
 
Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants
A Randomized Pilot Trial Comparing Cetaphil® Restoraderm® System and Standard Skin Care in Infants at Risk for Atopic Dermatitis

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Atopic Dermatitis
  • Other: Cetaphil Restoraderm
    Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.
    Other Name: Cetaphil Restoraderm
  • 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.
    Other Name: Johnson&Johnson
  • Active Comparator: 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: Other: Standard of Care
  • Experimental: Cetaphil Restoraderm
    Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.
    Intervention: Other: Cetaphil Restoraderm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
July 2014
July 2013   (final data collection date for primary outcome measure)

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
Both
up to 3 Weeks
No
Contact: Maureen Keene 503-228-7350 keenem@ohsu.edu
United States
 
NCT01375205
Galderma Cetaphil Restoraderm
No
Eric Simpson, MD, MCR, Oregon Health & Science University
Oregon Health and Science University
Galderma
Principal Investigator: Eric Simpson, MD, MCR Oregon Health and Science University
Oregon Health and Science University
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP