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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
History of Changes
  Purpose

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


Condition Intervention
Atopic Dermatitis
 Other: Soak and smear
Other: Dry Smear

Study Type: Interventional
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:

MedlinePlus related topics: Eczema Steroids
U.S. FDA Resources

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.


Estimated Enrollment: 100
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01675232

Contacts
Contact: Lucinda Liu, BA Lucinda.Liu@yale.edu

Locations
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Richard J Antaya, MD Yale University
  More Information

No publications provided

Responsible Party: Richard Antaya, Professor of Dermatology and Pediatrics, Yale University
ClinicalTrials.gov Identifier: NCT01675232     History of Changes
Other Study ID Numbers: HIC-1206010366
Study First Received: August 2, 2012
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Atopic dermatitis
Topical corticosteroid
Pediatric
Eczema

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
 Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013