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
Sponsor:
Information provided by (Responsible Party):
Richard Antaya, Yale University
ClinicalTrials.gov Identifier:
NCT01675232
First received: August 2, 2012
Last updated: January 28, 2013
Last verified: January 2013

August 2, 2012
January 28, 2013
July 2012
July 2013   (final data collection date for primary outcome measure)
Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01675232 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Atopic Dermatitis
  • Other: Soak and smear
    Corticosteroid ointment applied to wet skin once a day and dry skin once a day.
  • Other: Dry Smear
    Corticosteroid ointment applied to dry skin twice a day.
  • 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.
    Intervention: Other: Soak and smear
  • Active Comparator: Dry smear
    Application of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment to dry skin twice a day.
    Intervention: Other: Dry Smear
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
up to 18 Years
No
Contact: Lucinda Liu, BA Lucinda.Liu@yale.edu
United States
 
NCT01675232
HIC-1206010366
No
Richard Antaya, Yale University
Yale University
Not Provided
Principal Investigator: Richard J Antaya, MD Yale University
Yale University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP