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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675232
• Other study ID #: HIC-1206010366
• Status: Completed
• Phase: N/A
• First received: August 2, 2012
• Last updated: July 25, 2014
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2014
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Soak and smear
Corticosteroid ointment applied to wet skin once a day and dry skin once a day.
• Dry Smear
Corticosteroid ointment applied to dry skin twice a day.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI)		2 weeks	No
Secondary	Effect of corticosteroid ointment application regimens on serum cortisol		2 weeks after application of topical corticosteroids	Yes
Secondary	Frequency of atopic dermatitis flares in the 3 months following the two-week treatment regimen		3 months	No
Secondary	Adverse effects associated with each corticosteroid application regimen	Characterize and quantify adverse effects associated with each corticosteroid application regimen.	3 months	Yes