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

July 25, 2014 updated by: Richard Antaya, Yale University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Richard J Antaya, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

August 2, 2012

First Submitted That Met QC Criteria

August 25, 2012

First Posted (Estimate)

August 29, 2012

Study Record Updates

Last Update Posted (Estimate)

July 29, 2014

Last Update Submitted That Met QC Criteria

July 25, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIC-1206010366

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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