Back to resultsA Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Soak and smear
Dry Smear
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, Topical corticosteroid, Pediatric, Eczema
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.
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Soak and smear
Dry smear
Arm Description
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.
Application of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment to dry skin twice a day.
Outcomes
Primary Outcome Measures
Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI)
Secondary Outcome Measures
Effect of corticosteroid ointment application regimens on serum cortisol
Frequency of atopic dermatitis flares in the 3 months following the two-week treatment regimen
Adverse effects associated with each corticosteroid application regimen
Characterize and quantify adverse effects associated with each corticosteroid application regimen.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01675232
Brief Title
A Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis
Official Title
A Randomized, Investigator-Blinded Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic dermatitis, Topical corticosteroid, Pediatric, Eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Soak and smear
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dry smear
Arm Type
Active Comparator
Arm Description
Application of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment to dry skin twice a day.
Intervention Type
Other
Intervention Name(s)
Soak and smear
Intervention Description
Corticosteroid ointment applied to wet skin once a day and dry skin once a day.
Intervention Type
Other
Intervention Name(s)
Dry Smear
Intervention Description
Corticosteroid ointment applied to dry skin twice a day.
Primary Outcome Measure Information:
Title
Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Effect of corticosteroid ointment application regimens on serum cortisol
Time Frame
2 weeks after application of topical corticosteroids
Title
Frequency of atopic dermatitis flares in the 3 months following the two-week treatment regimen
Time Frame
3 months
Title
Adverse effects associated with each corticosteroid application regimen
Description
Characterize and quantify adverse effects associated with each corticosteroid application regimen.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard J Antaya, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis
We'll reach out to this number within 24 hrs