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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Withdrawn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
Wake Forest University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Atopic Dermatitis

Eligibility Criteria

2 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 28, 2011
    Last Updated
    July 3, 2018
    Sponsor
    Wake Forest University
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    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    Withdrawn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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