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

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

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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Other: Soak and smear
* Other: Dry Smear


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Weeks
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Soak and smear<br>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. | Other: Soak and smear<br>* Corticosteroid ointment applied to wet skin once a day and dry skin once a day.<br>|
| Active Comparator: Dry smear<br>Application of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment to dry skin twice a day. | Other: Dry Smear<br>* Corticosteroid ointment applied to dry skin twice a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI) |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of corticosteroid ointment application regimens on serum cortisol |  | 2 weeks after application of topical corticosteroids | 
| Frequency of atopic dermatitis flares in the 3 months following the two-week treatment regimen |  | 3 months | 
| Adverse effects associated with each corticosteroid application regimen | Characterize and quantify adverse effects associated with each corticosteroid application regimen. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic dermatitis, Topical corticosteroid, Pediatric, Eczema