Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants

• 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: Oregon Health and Science University
• Collaborator: Galderma R&D
• Information provided by (Responsible Party): Eric Simpson, Oregon Health and Science University

Tracking Information

• First Submitted Date: June 15, 2011
• First Posted Date: June 17, 2011
• Results First Submitted Date: January 22, 2019
• Results First Posted Date: April 12, 2019
• Last Update Posted Date: February 12, 2020
• Actual Study Start Date: June 2011
• Actual Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Other
• Condition: Atopic Dermatitis

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 22, 2019): 100
• Original Estimated Enrollment (submitted: June 16, 2011): 250
• Actual Study Completion Date: November 2015
• Actual Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Day to 3 Weeks (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01375205
• Other Study ID Numbers: Galderma Cetaphil Restoraderm
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Eric Simpson, Oregon Health and Science University
• Original Responsible Party: Eric Simpson, MD, MCR, Oregon Health & Science University
• Current Study Sponsor: Oregon Health and Science University
• Original Study Sponsor: Same as current
• Collaborators: Galderma R&D

Investigators

• Principal Investigator: Eric Simpson, MD, MCR; Oregon Health and Science University

• PRS Account: Oregon Health and Science University
• Verification Date: January 2020