Pediatric Atopic Dermatitis (AD) Internet Survey
Primary Purpose
Atopic Dermatitis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Weekly Internet survey
Topical Triamcinolone
Sponsored by
About this trial
This is an interventional health services research trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria:
- Any child age 2 to 8 with a diagnosis of atopic dermatitis confirmed by a dermatologist, together with the child's parent/guardian. Written consent must be given by parent/guardian.
Exclusion Criteria:
- Child is less than 2 or greater than 8 years of age.
- Known allergy or sensitivity to topical triamcinolone in the child.
- Inability to complete all study-related visits, or inability to complete the Internet survey due to inadequate Internet access.
- Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study. Subjects who are on systemic anti-inflammatory treatments for atopic dermatitis must be on a stable dose for at least 3 months prior to enrollment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Weekly Internet survey w medication
Topical triamcinolone only
Arm Description
Weekly survey via email plus topical triamcinolone
Standard of care
Outcomes
Primary Outcome Measures
Adherence to topical triamcinolone
Secondary Outcome Measures
Eczema Area Severity Index
Investigator's Global Assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01385527
Brief Title
Pediatric Atopic Dermatitis (AD) Internet Survey
Official Title
Using an Internet Survey to Improve Adherence in Pediatric Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
study was never initiated, No participants enrolled
Study Start Date
June 2011 (Actual)
Primary Completion Date
October 27, 2014 (Actual)
Study Completion Date
October 27, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate whether participation in an Internet-based intervention helps improve atopic dermatitis treatment outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Weekly Internet survey w medication
Arm Type
Experimental
Arm Description
Weekly survey via email plus topical triamcinolone
Arm Title
Topical triamcinolone only
Arm Type
Active Comparator
Arm Description
Standard of care
Intervention Type
Behavioral
Intervention Name(s)
Weekly Internet survey
Intervention Description
Parents will complete a weekly online survey about medication use.
Intervention Type
Drug
Intervention Name(s)
Topical Triamcinolone
Intervention Description
Topical triamcinolone to all affected areas once daily
Primary Outcome Measure Information:
Title
Adherence to topical triamcinolone
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Eczema Area Severity Index
Time Frame
12 weeks
Title
Investigator's Global Assessment
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any child age 2 to 8 with a diagnosis of atopic dermatitis confirmed by a dermatologist, together with the child's parent/guardian. Written consent must be given by parent/guardian.
Exclusion Criteria:
Child is less than 2 or greater than 8 years of age.
Known allergy or sensitivity to topical triamcinolone in the child.
Inability to complete all study-related visits, or inability to complete the Internet survey due to inadequate Internet access.
Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study. Subjects who are on systemic anti-inflammatory treatments for atopic dermatitis must be on a stable dose for at least 3 months prior to enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Feldman, MD, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pediatric Atopic Dermatitis (AD) Internet Survey
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