Eczema Prevention Study

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00806221
• Other study ID #: IRB00002726
• Status: Recruiting
• Phase: Phase 2
• First received: December 8, 2008
• Last updated: December 9, 2008
• Start date: November 2006
• Est. completion date: November 2010

Study information

• Verified date: December 2008
• Source: Oregon Health and Science University
• Contact: Maureen Keene
• Phone: 503-228-7350
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Month

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• emollient (Cetaphil cream)
Cetaphil cream applied daily from birth

Locations

Country	Name	City	State
United States	Oregon Health & Science University, Department of Dermatology	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	Galderma, National Eczema Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of skin irritation		1 and 2 year time points	Yes
Primary	Incidence of skin infection		1 and 2 year timepoints	Yes
Primary	Compliance with protocol		over two years	No
Secondary	Development of Eczema		1 and 2 year time points	No
Secondary	Skin Barrier Function Measurements		over 2 years	No