NCT02916888

Brief Summary

The purpose of this study is to investigate the differences in the quality of life of patients and caregivers who are treated by general pediatricians versus pediatric dermatologists for eczema (atopic dermatitis or AD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2016

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

September 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 11, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

September 23, 2016

Last Update Submit

January 9, 2018

Conditions

EczemaDermatitisDermatitis, AtopicGenetic Disease, InbornHypersensitivityHypersensitivity, ImmediateImmune System DiseasesSkin DiseasesSkin Diseases, EczematousSkin Diseases, Genetic

Keywords

Atopic dermatitisTopical corticosteroidPediatricEczemaQuality of life

Outcome Measures

Primary Outcomes (1)

  • Change in quality of life of patients

    Measured using Infant's Dermatitis Quality of Life Index (IDQoL) or Children's Dermatology Life Quality Index(CDLQI) depending on age

    2 weeks

Secondary Outcomes (3)

  • Change in quality of life of patient caregivers

    2 weeks

  • Change in clinical severity of atopic dermatitis

    2 weeks

  • Change in topical corticosteroid phobia in caregivers

    2 weeks

Study Arms (2)

Care provided by general pediatrician

Standard of care management of atopic dermatitis by general pediatrician. This includes an initial visit with a 2-week follow-up.

Other: Care provided by general pediatrician

Care provided by pediatric dermatologist

Standard of care management of atopic dermatitis by pediatric dermatologist. This includes an initial visit with a 2-week follow-up.

Other: Care provided by pediatric dermatologist

Interventions

Care provided by general pediatricianOTHER

Standard of care management of atopic dermatitis by a general pediatrician.

Care provided by general pediatrician
Care provided by pediatric dermatologistOTHER

Standard of care management of atopic dermatitis by a pediatric dermatologist.

Care provided by pediatric dermatologist

Eligibility Criteria

AgeUp to 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients under 7 years old that have atopic dermatitis from the Greater New Haven area.

You may qualify if:

  • Meet the clinical criteria for the diagnosis of atopic dermatitis
  • Have disease over at least 5% of their total body surface area.
  • Less than 7 years of age.
  • Families able to comprehend written instructions in English and able to complete questionnaires with assistance if needed.
  • Parents/guardians able to understand and willing to sign a parental permission form.

You may not qualify if:

  • Clinically infected atopic dermatitis.
  • Lack of follow-up after initial visit or regimen non-adherence.
  • Patients who are allergic or intolerant of the topical medications employed in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Dermatology Associates

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

  • Eichenfield LF, Tom WL, Chamlin SL, Feldman SR, Hanifin JM, Simpson EL, Berger TG, Bergman JN, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Krol A, Margolis DJ, Paller AS, Schwarzenberger K, Silverman RA, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014 Feb;70(2):338-51. doi: 10.1016/j.jaad.2013.10.010. Epub 2013 Nov 27.

    PMID: 24290431BACKGROUND

Biospecimen

Retention: NONE RETAINED

Saliva samples for salivary cortisol detection

MeSH Terms

Conditions

EczemaDermatitisDermatitis, AtopicGenetic Diseases, InbornHypersensitivityHypersensitivity, ImmediateImmune System DiseasesSkin DiseasesSkin Diseases, EczematousSkin Diseases, Genetic

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Richard Antaya, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2016

First Posted

September 28, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 11, 2018

Record last verified: 2018-01

Locations

US(1)