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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01675232

Enrollment

Registered

2012-08-29

Start date

2012-07-31

Completion date

2013-07-31

Last updated

2014-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis, Topical corticosteroid, Pediatric, Eczema

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).

Interventions

OTHERSoak and smear

Corticosteroid ointment applied to wet skin once a day and dry skin once a day.

OTHERDry Smear

Corticosteroid ointment applied to dry skin twice a day.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Weeks to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	3 months	Characterize and quantify adverse effects associated with each corticosteroid application regimen.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026