Pediatric Atopic Dermatitis (AD) Internet Survey

This study is currently recruiting participants.

Verified February 2013 by Wake Forest University

Sponsor:

Information provided by (Responsible Party):

Steven R. Feldman, Wake Forest University

ClinicalTrials.gov Identifier:

NCT01385527

First received: June 28, 2011

Last updated: February 21, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 28, 2011

Last Updated Date

February 21, 2013

Start Date ^ICMJE

June 2011

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Adherence to topical triamcinolone [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01385527 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Eczema Area Severity Index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Investigator's Global Assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pediatric Atopic Dermatitis (AD) Internet Survey

Official Title ^ICMJE

Using an Internet Survey to Improve Adherence in Pediatric Atopic Dermatitis

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research

Condition ^ICMJE

Atopic Dermatitis

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Weekly Internet survey plus topical triamcinolone
Interventions:
- Behavioral: Weekly Internet survey
- Drug: Topical Triamcinolone
Active Comparator: Topical triamcinolone only (standard-of-care)
Intervention: Drug: Topical Triamcinolone

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

2 Years to 8 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Susie C Dowd	3367163775	sdowd@wakehealth.edu
Contact: Scott A Davis, MA	3367162702	scdavis@wakehealth.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01385527

Other Study ID Numbers ^ICMJE

00016545

Has Data Monitoring Committee

Responsible Party

Steven R. Feldman, Wake Forest University

Study Sponsor ^ICMJE

Wake Forest University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Steven R Feldman, MD, PhD

Wake Forest University

Information Provided By

Wake Forest University

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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