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OpenTrials
Completed

NCT Number: NCT00806221

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oregon Health & Science University, Department of Dermatology

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

emollient (Cetaphil cream)

Drug

Cetaphil cream applied daily from birth

Primary outcomes

  1. Incidence of Skin Irritation

    Time frame: 1 and 2 year time points

  2. Incidence of Skin Infection

    Time frame: 1 and 2 year timepoints

  3. Compliance With Protocol

    Time frame: over two years

Secondary outcomes

  1. Development of Eczema

    Time frame: 1 and 2 year time points

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Galderma R&D

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Dec 10, 2008
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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