Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT01375205
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2011-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants
Sponsor:
Oregon Health and Science University
Organization:
Study Overview
Official Title:
A Randomized Pilot Trial Comparing Cetaphil® Restoraderm® System and Standard Skin Care in Infants at Risk for Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: