A Randomized, Investigator-Blinded Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis

Yale University1 site in 1 country45 target enrollmentJuly 2012

ConditionsAtopic Dermatitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atopic Dermatitis
Sponsor: Yale University
Enrollment: 45
Locations: 1
Primary Endpoint: Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate the efficacy of two different corticosteroid ointment application regimens for the treatment of eczema (atopic dermatitis).

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

July 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yale University

Responsible Party

Principal Investigator

Richard Antaya

Professor of Dermatology and Pediatrics

Yale University

Eligibility Criteria

Inclusion Criteria

•Meet the clinical criteria for the diagnosis of atopic dermatitis
•Have disease over at least 5% of their total body surface area.
•Less than 18 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.
•Children between the ages of 7-17 years willing to sign an age-appropriate assent form.

Exclusion Criteria

•Patients who are allergic or intolerant of the topical medications employed in this study.
•Lack of follow-up after initial visit or regimen noncompliance.
•Patients who do not have access to a bathtub.

Outcomes

Primary Outcomes

Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI)

Time Frame: 2 weeks

Secondary Outcomes

Adverse effects associated with each corticosteroid application regimen(3 months)
Frequency of atopic dermatitis flares in the 3 months following the two-week treatment regimen(3 months)
Effect of corticosteroid ointment application regimens on serum cortisol(2 weeks after application of topical corticosteroids)