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

June 9, 2017 updated by: Eric Simpson, Oregon Health and Science University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University, Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Emollient
Skin barrier protection from birth
Drug: emollient (Cetaphil cream)
Cetaphil cream applied daily from birth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Skin Irritation
Time Frame: 1 and 2 year time points
1 and 2 year time points
Incidence of Skin Infection
Time Frame: 1 and 2 year timepoints
1 and 2 year timepoints
Compliance With Protocol
Time Frame: over two years
over two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Development of Eczema
Time Frame: 1 and 2 year time points
1 and 2 year time points

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

December 8, 2008

First Submitted That Met QC Criteria

December 9, 2008

First Posted (Estimate)

December 10, 2008

Study Record Updates

Last Update Posted (Actual)

July 11, 2017

Last Update Submitted That Met QC Criteria

June 9, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00002726

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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