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Pediatric Atopic Dermatitis (AD) Internet Survey

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ClinicalTrials.gov Identifier: NCT01385527
Recruitment Status : Withdrawn (study was never initiated, No participants enrolled)
First Posted : June 30, 2011
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Brief Summary:
The purpose of this study is to evaluate whether participation in an Internet-based intervention helps improve atopic dermatitis treatment outcomes.

Condition or disease Intervention/treatment
Atopic Dermatitis Behavioral: Weekly Internet survey Drug: Topical Triamcinolone

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Using an Internet Survey to Improve Adherence in Pediatric Atopic Dermatitis
Actual Study Start Date : June 2011
Primary Completion Date : October 27, 2014
Study Completion Date : October 27, 2014


Arm Intervention/treatment
Experimental: Weekly Internet survey w medication
Weekly survey via email plus topical triamcinolone
Behavioral: Weekly Internet survey
Parents will complete a weekly online survey about medication use.
Drug: Topical Triamcinolone
Topical triamcinolone to all affected areas once daily
Active Comparator: Topical triamcinolone only
Standard of care
Drug: Topical Triamcinolone
Topical triamcinolone to all affected areas once daily



Primary Outcome Measures :
  1. Adherence to topical triamcinolone [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Eczema Area Severity Index [ Time Frame: 12 weeks ]
  2. Investigator's Global Assessment [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01385527


Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Steven R Feldman, MD, PhD Wake Forest University Health Sciences

Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT01385527     History of Changes
Other Study ID Numbers: 00016545
First Posted: June 30, 2011    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action