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

NCT01675232 | Completed

• 1 other identifier: HIC-1206010366
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; Topical corticosteroid; Pediatric; Eczema

Outcome Measures

Primary Outcomes (1)

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

  2 weeks

Secondary Outcomes (3)

• Effect of corticosteroid ointment application regimens on serum cortisol

  2 weeks after application of topical corticosteroids

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

  3 months

• Adverse effects associated with each corticosteroid application regimen

  3 months

Study Arms (2)

Soak and smear

ACTIVE COMPARATOR

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

Dry smear

ACTIVE COMPARATOR

Application of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment to dry skin twice a day.

Other: Dry Smear

Interventions

Soak and smear OTHER

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

Soak and smear

Dry Smear OTHER

Corticosteroid ointment applied to dry skin twice a day.

Dry smear

Eligibility Criteria

• Age: 2 Weeks - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

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

Study Officials

• Richard J Antaya, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology and Pediatrics

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 29, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 29, 2014

Record last verified: 2014-07

Locations

US (1)