A Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis
This study is currently recruiting participants.
Verified January 2013 by Yale University
Information provided by (Responsible Party):
Richard Antaya, Yale University
First received: August 2, 2012
Last updated: January 28, 2013
Last verified: January 2013
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Investigator-Blinded Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis|
Resource links provided by NLM:
Further study details as provided by Yale University:
Primary Outcome Measures:
- Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Effect of corticosteroid ointment application regimens on serum cortisol [ Time Frame: 2 weeks after application of topical corticosteroids ] [ Designated as safety issue: Yes ]
- Frequency of atopic dermatitis flares in the 3 months following the two-week treatment regimen [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Adverse effects associated with each corticosteroid application regimen [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Characterize and quantify adverse effects associated with each corticosteroid application regimen.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01675232
|Contact: Lucinda Liu, BA||Lucinda.Liu@yale.edu|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06510|
Sponsors and Collaborators
|Principal Investigator:||Richard J Antaya, MD||Yale University|