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Completed

NCT Number: NCT01675232

A 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).

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 week–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Soak and smear

Other

Corticosteroid ointment applied to wet skin once a day and dry skin once a day.

Dry Smear

Other

Corticosteroid ointment applied to dry skin twice a day.

Primary outcomes

  1. Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI)

    Time frame: 2 weeks

Secondary outcomes

  1. Effect of corticosteroid ointment application regimens on serum cortisol

    Time frame: 2 weeks after application of topical corticosteroids

  2. Frequency of atopic dermatitis flares in the 3 months following the two-week treatment regimen

    Time frame: 3 months

  3. Adverse effects associated with each corticosteroid application regimen

    Time frame: 3 months

    Characterize and quantify adverse effects associated with each corticosteroid application regimen.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

A Randomized, Investigator-Blinded Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 29, 2012
Registry last updated
Jul 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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