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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
Information provided by (Responsible Party):
Eric Simpson, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Other: Cetaphil Restoraderm Other: Standard of Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized Pilot Trial Comparing Cetaphil® Restoraderm® System and Standard Skin Care in Infants at Risk for Atopic Dermatitis
Actual Study Start Date : June 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Cetaphil

Arm Intervention/treatment
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.
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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 3 Weeks   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375205


Locations
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United States, Oregon
Oregon Health & Science University Center for Health & Healing
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Galderma
Investigators
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Principal Investigator: Eric Simpson, MD, MCR Oregon Health and Science University
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Responsible Party: Eric Simpson, M.D., M.C.R., Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01375205    
Other Study ID Numbers: Galderma Cetaphil Restoraderm
First Posted: June 17, 2011    Key Record Dates
Results First Posted: April 12, 2019
Last Update Posted: February 12, 2020
Last Verified: January 2020
Keywords provided by Eric Simpson, Oregon Health and Science University:
atopic dermatitis
skin care
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases