NCT00806221

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 8, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
7.7 years until next milestone

Results Posted

Study results publicly available

July 11, 2017

Completed
Last Updated

July 11, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

December 8, 2008

Results QC Date

May 17, 2017

Last Update Submit

June 9, 2017

Conditions

Atopic Dermatitis

Keywords

Atopic DermatitisPreventionSkin Barrier

Outcome Measures

Primary Outcomes (3)

  • Incidence of Skin Irritation

    1 and 2 year time points

  • Incidence of Skin Infection

    1 and 2 year timepoints

  • Compliance With Protocol

    over two years

Secondary Outcomes (1)

  • Development of Eczema

    1 and 2 year time points

Study Arms (1)

Emollient

EXPERIMENTAL

Skin barrier protection from birth

Drug: emollient (Cetaphil cream)

Interventions

emollient (Cetaphil cream)DRUG

Cetaphil cream applied daily from birth

Emollient

Eligibility Criteria

AgeUp to 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • at least one parent diagnosed with Atopic Dermatitis
  • one parent or sibling with hayfever or asthma

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University, Department of Dermatology

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Emollients

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Dermatologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Results Point of Contact

Title
Eric Simpson, MD, MCR
Organization
Oregon Health & Science University
simpsone@ohsu.edu
503-494-2121

Study Officials

  • Eric Simpson, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Dermatology

Study Record Dates

First Submitted

December 8, 2008

First Posted

December 10, 2008

Study Start

November 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2009

Last Updated

July 11, 2017

Results First Posted

July 11, 2017

Record last verified: 2017-06

Locations

US(1)