Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis, Prevention, Skin Barrier
Brief summary
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.
Detailed description
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.
Interventions
DRUGemollient (Cetaphil cream)
Cetaphil cream applied daily from birth
Sponsors
Galderma R&D
Oregon Health and Science University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Skin Irritation | 1 and 2 year time points |
| Incidence of Skin Infection | 1 and 2 year timepoints |
| Compliance With Protocol | over two years |
Secondary
| Measure | Time frame |
|---|---|
| Development of Eczema | 1 and 2 year time points |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Emollient Skin barrier protection from birth
emollient (Cetaphil cream): Cetaphil cream applied daily from birth | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Emollient |
|---|---|
| Age, Categorical <=18 years | 22 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race/Ethnicity, Customized African American | 2 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Hispanic Caucasian | 2 Participants |
| Race/Ethnicity, Customized non-Hispanic Caucasian | 16 Participants |
| Region of Enrollment United States | 22 participants |
| Sex/Gender, Customized gender/sex was not recorded | 22 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
Compliance With Protocol
Time frame: over two years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Emollient | Compliance With Protocol | 20 participants |
Primary
Incidence of Skin Infection
Time frame: 1 and 2 year timepoints
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Emollient | Incidence of Skin Infection | 0 Participants |
Primary
Incidence of Skin Irritation
Time frame: 1 and 2 year time points
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Emollient | Incidence of Skin Irritation | 0 Participants |
Secondary
Development of Eczema
Time frame: 1 and 2 year time points
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Emollient | Development of Eczema | 5 Participants |