A Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis

Not Applicable

Completed

• Conditions: Atopic Dermatitis
• Interventions: Other: Soak and smear; Other: Dry Smear

• Registration Number: NCT01675232
• Lead Sponsor: Yale University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-02
• Study First Submitted QC: 2012-08-25
• Study First Posted: 2012-08-29
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-25
• Last Update Posted: 2014-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Soak and smear	Soak and smear	Application of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment immediately to wet skin once a day and dry skin once a day.
Dry smear	Dry Smear	Application of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment to dry skin twice a day.

Primary Outcome Measures

Name	Time	Method
Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI)	2 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse effects associated with each corticosteroid application regimen	3 months	Characterize and quantify adverse effects associated with each corticosteroid application regimen.
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

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States