Infant Skin Care Study
This study is looking at which skin care products are the best for babies’ skin
Dr. Eric Simpson, a dermatologist from Oregon Health & Science University (OHSU), is studying eczema prevention in newborns. We are enrolling babies younger than three weeks old with at least one family member affected by seasonal allergies, eczema or asthma. All study participants will receive compensation for their time and travel as well as one year of free skin care.
We are recruiting women between the ages of 18 and 45 who are in their third trimester of pregnancy and full term (greater than 37 weeks of gestation) infants who are up to three weeks old.
All babies in this study will be given free skin care for one year with either the current standard of care for infant skin, Johnson's® Baby Lotion and Head-to-Toe® Baby Wash, or the trial skin care system, Cetaphil® Restoraderm® cleanser and lotion. Participants will be assessed at two, six, and 12 months of age to evaluate the effect of each skin care regimen on eczema development.
What is eczema?Eczema affects about one in five children in the U.S.A. It is an inflammation of the skin that appears red, dry and scaly. The main symptom of eczema is itching, which can range from very mild to very severe. Severe itching makes a child want to scratch all the time. This is often worse at night, which leads to poor sleep for both the child and parents. In the moderate and severe cases, children may scratch their skin until it bleeds, which may lead to skin infections and other complications.
Purpose of the studyThe aim of this study is to determine the effect of two different skin care products on your baby’s skin. The two skin care products we are testing are Cetaphil® Restoraderm® system and Johnson's® Baby Lotion and Head-to-Toe® Baby Wash. We would also like to know whether use of these products can prevent the development of eczema. Some moisturizers may make the skin more sensitive while other moisturizers may protect the skin.
Who is taking part in this study?About 200 pregnant women and newborns from the greater Portland area will be invited to take part in this study. To be eligible, at least one member of the immediate family must have a history of one or more of the following:
- Seasonal allergies
Babies born into families with these health problems are more likely to develop eczema.
What will happen in the study?Study participants will be randomly placed into one of two groups: (1) standard of care group or (2) test emollient group. Both groups will receive skin care and allergy prevention advice and a one year supply of skin care products. Participants in the standard of care group will receive Johnson's® products to be applied as often as desired, and participants in the test emollient group will apply Cetaphil® Restoraderm® products once per day.
What is the time commitment to participate in the study?
Families participating in the study will have regular contact with the research team, who will answer questions and address study concerns. Infants will also be assessed for skin problems. Details of these appointments are below:
During pregnancy (optional visit)
An appointment will be scheduled to see you before the birth of your baby to discuss the study and to make sure you are eligible for the study. This may be combined with your enrollment visit.
Within 3 weeks after the birth of your baby
An enrollment contact will take place to assess your baby's eligibility for the study. This occurs as soon as possible after delivery. Your baby will be randomly assigned to one of the two groups and given skin care products and guidelines for use of the products. This visit may occur in the hospital, at your child's first pediatrician visit, or over the phone.
Fourteen days after study enrollment
A member of the research team will call to check up on your baby.
Two, six and twelve month visits
Your baby's skin will be assessed at these visits to check for signs of eczema and study procedures will be discussed.
All families will participate in the study for 12 months