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
  Purpose

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 Intervention
Atopic Dermatitis
Other: Cetaphil Restoraderm
Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: A Randomized Pilot Trial Comparing Cetaphil® Restoraderm® System and Standard Skin Care in Infants at Risk for Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 250
Study Start Date: June 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
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.
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.
Other Name: Cetaphil Restoraderm

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.

  Eligibility

Ages Eligible for Study:   up to 3 Weeks
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375205

Contacts
Contact: Maureen Keene 503-228-7350 keenem@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Center for Health & Healing Recruiting
Portland, Oregon, United States, 97239
Contact: Maureen Keene    503-228-7350    keenem@ohsu.edu   
Principal Investigator: Eric Simpson, MD, MCR         
Sponsors and Collaborators
Oregon Health and Science University
Galderma
Investigators
Principal Investigator: Eric Simpson, MD, MCR Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Eric Simpson, MD, MCR, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT01375205     History of Changes
Other Study ID Numbers: Galderma Cetaphil Restoraderm
Study First Received: June 15, 2011
Last Updated: June 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
atopic dermatitis
skin care

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014