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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:
Collaborator:
Galderma
Information provided by (Responsible Party):
Eric Simpson, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00806221
First received: December 8, 2008
Last updated: June 9, 2017
Last verified: June 2017
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 8, 2008
Results First Received: May 17, 2017
Last Updated: June 9, 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

ClinicalTrials.gov processed this record on August 21, 2017