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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00806221
First Posted: December 10, 2008
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Galderma
Information provided by (Responsible Party):
Eric Simpson, Oregon Health and Science University
  Purpose
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.

Condition Intervention Phase
Atopic Dermatitis Drug: emollient (Cetaphil cream) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Eric Simpson, Oregon Health and Science University:

Primary Outcome Measures:
  • Incidence of Skin Irritation [ Time Frame: 1 and 2 year time points ]
  • Incidence of Skin Infection [ Time Frame: 1 and 2 year timepoints ]
  • Compliance With Protocol [ Time Frame: over two years ]

Secondary Outcome Measures:
  • Development of Eczema [ Time Frame: 1 and 2 year time points ]

Enrollment: 22
Study Start Date: November 2006
Study Completion Date: November 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Emollient
Skin barrier protection from birth
Drug: emollient (Cetaphil cream)
Cetaphil cream applied daily from birth

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806221


Locations
United States, Oregon
Oregon Health & Science University, Department of Dermatology
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Galderma
Investigators
Principal Investigator: Eric Simpson, MD Oregon Health and Science University
  More Information

Responsible Party: Eric Simpson, Professor, Dermatology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00806221     History of Changes
Other Study ID Numbers: IRB00002726
First Submitted: December 8, 2008
First Posted: December 10, 2008
Results First Submitted: May 17, 2017
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017
Last Verified: June 2017

Keywords provided by Eric Simpson, Oregon Health and Science University:
Atopic Dermatitis
Prevention
Skin Barrier

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Emollients
Dermatologic Agents