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History of Changes for Study: NCT01375205
Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants
Latest version (submitted January 30, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 16, 2011 None (earliest Version on record)
2 June 20, 2011 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 January 22, 2019 Recruitment Status, Study Status, Sponsor/Collaborators, Contacts/Locations, Study Design, Outcome Measures and Results
4 January 30, 2020 Outcome Measures, Adverse Events and Study Status
Comparison Format:

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Study NCT01375205
Submitted Date:  June 16, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: Galderma Cetaphil Restoraderm
Brief Title: Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants
Official Title: A Randomized Pilot Trial Comparing Cetaphil® Restoraderm® System and Standard Skin Care in Infants at Risk for Atopic Dermatitis
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2011
Overall Status: Not yet recruiting
Study Start: July 2011
Primary Completion: July 2013 [Anticipated]
Study Completion: July 2014 [Anticipated]
First Submitted: June 15, 2011
First Submitted that
Met QC Criteria:
June 16, 2011
First Posted: June 17, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 16, 2011
Last Update Posted: June 17, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Oregon Health and Science University
Responsible Party:
Collaborators: Galderma R&D
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
skin care
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Outcomes Assessor)
Allocation: Randomized
Enrollment: 250 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
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 Names:
  • Johnson&Johnson
Experimental: Cetaphil Restoraderm
Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.
Cetaphil Restoraderm
Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of atopic dermatitis
[ Time Frame: 12 months ]

The primary outcome will be the cumulative incidence of AD at one year.
Secondary Outcome Measures:
1. 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.
Open or close this module Eligibility
Minimum Age: 1 Day
Maximum Age: 3 Weeks
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Maureen Keene
Telephone: 503-228-7350
Email: keenem@ohsu.edu
Study Officials: Eric Simpson, MD, MCR
Principal Investigator
Oregon Health and Science University
Locations: United States, Oregon
Oregon Health & Science University Center for Health & Healing
Portland, Oregon, United States, 97239
Contact:Contact: Maureen Keene 503-228-7350 keenem@ohsu.edu
Contact:Principal Investigator: Eric Simpson, MD, MCR
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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