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Eczema Prevention Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
National Eczema Association
Galderma
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00806221
First received: December 8, 2008
Last updated: December 9, 2008
Last verified: December 2008
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Eczema
Drug Information available for: Cetaphil
U.S. FDA Resources

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

Primary Outcome Measures:
  • Incidence of skin irritation [ Time Frame: 1 and 2 year time points ] [ Designated as safety issue: Yes ]
  • Incidence of skin infection [ Time Frame: 1 and 2 year timepoints ] [ Designated as safety issue: Yes ]
  • Compliance with protocol [ Time Frame: over two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Development of Eczema [ Time Frame: 1 and 2 year time points ] [ Designated as safety issue: No ]
  • Skin Barrier Function Measurements [ Time Frame: over 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: November 2006
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (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

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806221

Contacts
Contact: Maureen Keene 503-228-7350

Locations
United States, Oregon
Oregon Health & Science University, Department of Dermatology Recruiting
Portland, Oregon, United States, 97239
Contact: Maureen Keene     503-228-7350        
Principal Investigator: Eric Simpson, MD            
Sub-Investigator: Jon Hanifin, MD            
Sub-Investigator: Alfons Krol, MD            
Sub-Investigator: Susan Tofte, RN, MS, FNP            
Sponsors and Collaborators
Oregon Health and Science University
National Eczema Association
Galderma
Investigators
Principal Investigator: Eric Simpson, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Eric Simpson, MD/ Principal Investigator, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00806221     History of Changes
Other Study ID Numbers: IRB00002726
Study First Received: December 8, 2008
Last Updated: December 9, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 21, 2013