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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01675232
First Posted: August 29, 2012
Last Update Posted: July 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Richard Antaya, Yale University
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Richard Antaya, Yale University:

Primary Outcome Measures:
  • Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI) [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • Effect of corticosteroid ointment application regimens on serum cortisol [ Time Frame: 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 ]
  • Adverse effects associated with each corticosteroid application regimen [ Time Frame: 3 months ]
    Characterize and quantify adverse effects associated with each corticosteroid application regimen.


Enrollment: 45
Study Start Date: July 2012
Study Completion Date: July 2013
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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675232


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

Responsible Party: Richard Antaya, Professor of Dermatology and Pediatrics, Yale University
ClinicalTrials.gov Identifier: NCT01675232     History of Changes
Other Study ID Numbers: HIC-1206010366
First Submitted: August 2, 2012
First Posted: August 29, 2012
Last Update Posted: July 29, 2014
Last Verified: July 2014

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

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Triamcinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors