Feasibility Study of Barrier Enhancement for Eczema Prevention (BEEP)

Oregon Health & Science University (OHSU)

Status: Unknown

Conditions: Eczema

Treatments: Drug: Control group; Drug: Cetaphil cream; Drug: Aquaphor ointment; Drug: Sunflower oil

Study type: Interventional

Funder types: Other

Identifiers

NCT01142999

BEEP

Details and patient eligibility

About

The purpose of this protocol is to determine the feasibility of doing larger follow-up studies examining whether emollients used from birth can prevent eczema in high-risk babies and to help investigators find out if emollients (moisturizing skin creams) used from birth can prevent eczema in high-risk babies. Hypothesis: Enhancing the skin barrier from birth using emollients will prevent or delay the onset of eczema, especially in predisposed infants.

Enrollment: 46 patients

Sex: All

Ages: 1 minute to 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participant must have a parent or sibling with a history of at least one of the following: eczema, allergic rhinitis or asthma
2. Infant in overall good health
3. Mother between the ages of 16 and 45 years of age at delivery; infant from birth thru 6 months of age
4. Capable of giving informed consent

Exclusion criteria

1. Preterm birth defined as birth prior to 37 weeks gestation
2. Major congenital anomaly
3. Hydrops fetalis
4. Significant dermatitis at birth not including seborrheic dermatitis ("cradle cap")
5. Any immunodeficiency disorder or severe genetic skin disorder
6. Any other serious condition that would make the use of emollients inadvisable
7. Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

46 participants in 2 patient groups

Intervention (moisturizer group)

Active Comparator group

Description:

One group will be instructed to use a choice of 3 FDA-approved moisturizers and soap substitutes on their newborn infants.

Treatment:

Drug: Cetaphil cream

Drug: Sunflower oil

Drug: Aquaphor ointment

Control group (no moisturizers)

Active Comparator group

Description:

This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants.

Treatment:

Drug: Control group