Official Title

An Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Study Participants

    22
The purpose of this study is to determine whether early use of a bland emollient in newborns, prior to the clinical signs of skin disease, will delay the onset or prevent the development of atopic dermatitis.
All neonates will be treated with Cetaphil cream starting within 1 week of birth. All neonates enrolled will have an increased risk of developing atopic dermatitis because they have a family history of either asthma, hay fever, or atopic dermatitis. These neonates will then be followed for 2 years for the signs and symptoms of atopic dermatitis.
Study Started
Nov 30
2006
Primary Completion
Nov 30
2008
Study Completion
Nov 30
2009
Results Posted
Jul 11
2017
Last Update
Jul 11
2017

Drug emollient (Cetaphil cream)

Cetaphil cream applied daily from birth

Emollient Experimental

Skin barrier protection from birth

Criteria

Inclusion Criteria:

at least one parent diagnosed with Atopic Dermatitis
one parent or sibling with hayfever or asthma

Exclusion Criteria:

newborns with dermatitis at birth
newborns born greater than four weeks prematurely
newborns with medical problems necessitating prolonged hospitalization
newborns diagnosed with any immune deficiency syndrome

Summary

Emollient

All Events

Event Type Organ System Event Term

Incidence of Skin Irritation

Emollient

Incidence of Skin Infection

Emollient

Compliance With Protocol

Emollient

20.0
participants

Development of Eczema

Emollient

Age, Categorical

Race/Ethnicity, Customized

Region of Enrollment

Sex/Gender, Customized

Overall Study

Emollient