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

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: emollient (Cetaphil cream)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00806221

IRB00002726

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: Under 1 month old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Emollient

Experimental group

Description:

Skin barrier protection from birth

Treatment:

Drug: emollient (Cetaphil cream)