NCT01142999

Brief Summary

The purpose of this protocol is to determine the feasibility of doing larger follow-up studies examining whether emollients used from birth can prevent eczema in high-risk babies and to help investigators find out if emollients (moisturizing skin creams) used from birth can prevent eczema in high-risk babies. Hypothesis: Enhancing the skin barrier from birth using emollients will prevent or delay the onset of eczema, especially in predisposed infants.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

August 5, 2011

Status Verified

June 1, 2010

Enrollment Period

1.3 years

First QC Date

June 10, 2010

Last Update Submit

August 4, 2011

Conditions

Eczema

Outcome Measures

Primary Outcomes (1)

  • Proportion of families willing to be randomized.

    Determine proportion of families willing to be randomized in order to design larger study in the future.

    6 months

Secondary Outcomes (10)

  • Proportion of families eligible for the trial, willing to participate

    6 months

  • Proportion of families who found the interventions acceptable

    6 months

  • Reported adherence with intervention

    6 months

  • Proportion of families for whom the blinding of the assessor to the allocation ostatus was not compromised

    6 months

  • Amount of contamination as a result of increased awareness in the control group

    6 months

  • +5 more secondary outcomes

Study Arms (2)

Intervention (moisturizer group)

ACTIVE COMPARATOR

One group will be instructed to use a choice of 3 FDA-approved moisturizers and soap substitutes on their newborn infants.

Drug: Sunflower oilDrug: Aquaphor ointmentDrug: Cetaphil cream

Control group (no moisturizers)

ACTIVE COMPARATOR

This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants.

Drug: Control group

Interventions

Sunflower oilDRUG

One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.

Also known as: Moisturizers
Intervention (moisturizer group)
Control groupDRUG

This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants.

Control group (no moisturizers)
Aquaphor ointmentDRUG

One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.

Intervention (moisturizer group)
Cetaphil creamDRUG

One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.

Intervention (moisturizer group)

Eligibility Criteria

Age1 Minute - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Participant must have a parent or sibling with a history of at least one of the following: eczema, allergic rhinitis or asthma
  • Infant in overall good health
  • Mother between the ages of 16 and 45 years of age at delivery; infant from birth thru 6 months of age
  • Capable of giving informed consent

You may not qualify if:

  • Preterm birth defined as birth prior to 37 weeks gestation
  • Major congenital anomaly
  • Hydrops fetalis
  • Significant dermatitis at birth not including seborrheic dermatitis ("cradle cap")
  • Any immunodeficiency disorder or severe genetic skin disorder
  • Any other serious condition that would make the use of emollients inadvisable
  • Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Eczema

Interventions

Sunflower OilControl Groups

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Plant OilsPlant PreparationsBiological ProductsComplex MixturesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Eric L. Simpson, M.D., M.C.R.

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 10, 2010

First Posted

June 14, 2010

Study Start

May 1, 2010

Primary Completion

August 1, 2011

Study Completion

September 1, 2012

Last Updated

August 5, 2011

Record last verified: 2010-06

Locations

US(1)