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Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01375205
Recruitment Status : Completed
First Posted : June 17, 2011
Results First Posted : April 12, 2019
Last Update Posted : February 12, 2020
Sponsor:
Collaborator:
Galderma R&D
Information provided by (Responsible Party):
Eric Simpson, Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE June 15, 2011
First Posted Date  ICMJE June 17, 2011
Results First Submitted Date  ICMJE January 22, 2019
Results First Posted Date  ICMJE April 12, 2019
Last Update Posted Date February 12, 2020
Actual Study Start Date  ICMJE June 2011
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 16, 2011)
Incidence of atopic dermatitis [ Time Frame: 12 months ]
The primary outcome will be the cumulative incidence of AD at one year.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • 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.
  • Age at Onset of Eczema [ Time Frame: Baseline through Month 24 Follow-up ]
    Age of subject at onset of eczema
  • Filaggrin Mutation Status [ Time Frame: 6 month visit ]
    Filaggrin mutation status result
  • Transepidermal Water Loss (TEWL) [ Time Frame: 2 month, 6 month, and 12 month visits ]
    Transepidermal water loss (TEWL) to measure skin barrier function
  • Skin Hydration (Skin Electrical Capacitance) [ Time Frame: 2 month, 6 month, and 12 month visits ]
    Determination of stratum corneum hydration from the dorsal forearm
  • Skin pH [ Time Frame: 2 month, 6 month, and 12 month visits ]
    Skin pH, as measured using a pH probe
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2011)
Effects on infants' skin barrier [ Time Frame: 12 months ]
Secondary outcomes include adherence measures, time to disease onset, adverse events, and skin barrier function in a sub-set of subjects.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants
Official Title  ICMJE A Randomized Pilot Trial Comparing Cetaphil® Restoraderm® System and Standard Skin Care in Infants at Risk for Atopic Dermatitis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • 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: 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2019)
100
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2011)
250
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 3 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01375205
Other Study ID Numbers  ICMJE Galderma Cetaphil Restoraderm
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric Simpson, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Galderma R&D
Investigators  ICMJE
Principal Investigator: Eric Simpson, MD, MCR Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date January 2020

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