Completed
A Randomized, Investigator-Blinded Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis
What is being tested
Soak and smear
+ Dry Smear
Other
Who is being recruted
Dermatitis+9
+ Hypersensitivity
+ Hypersensitivity, Immediate
+9 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: July 2012
Summary
Principal SponsorYale University
Last updated: July 29, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2012
Actual date on which the first participant was enrolled.The purpose of this study is to investigate the efficacy of two different corticosteroid ointment application regimens for the treatment of eczema (atopic dermatitis).
Principal SponsorYale University
Last updated: July 29, 2014
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
45 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Range of ages for which participants are eligible to join.
Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
DermatitisHypersensitivityHypersensitivity, ImmediateImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin Diseases, GeneticSkin and Connective Tissue DiseasesSkin Diseases, EczematousGenetic Diseases, InbornDermatitis, AtopicEczema
Criteria
6 inclusion criteria required to participate
Children between the ages of 7-17 years willing to sign an age-appropriate assent form
Families able to comprehend written instructions in English and able to complete questionnaires with assistance if needed
Have disease over at least 5% of their total body surface area
Less than 18 years of age
Show More Criteria
3 exclusion criteria prevent from participating
Lack of follow-up after initial visit or regimen noncompliance
Patients who are allergic or intolerant of the topical medications employed in this study
Patients who do not have access to a bathtub
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorApplication of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment immediately to wet skin once a day and dry skin once a day.
Group II
Active ComparatorApplication of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment to dry skin twice a day.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center