Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants
This study is currently recruiting participants.
Verified June 2011 by Oregon Health and Science University
Sponsor:
Oregon Health and Science University
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
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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
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 May 19, 2013