Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT01375205
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:
NCT01375205
Study Brief:
Protocol Section:
NCT01375205