Pediatric Atopic Dermatitis (AD) Internet Survey | NCT01385527

Studies
Pediatric Atopic Dermatitis (AD) Internet Survey

NCT01385527

Sponsor

Wake Forest University

Status

Withdrawn

Last Update Posted

Jul 6, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Atopic Dermatitis

Interventions

Weekly Internet survey
Topical Triamcinolone

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

study was never initiated, No participants enrolled

Expanded Access Info

Start Date

Jun 2011Actual

Primary Completion Date

Oct 27, 2014Actual

Completion Date

Oct 27, 2014Actual

First Submitted Date

Jun 28, 2011

First Submission Date that Met QC Criteria

Jun 28, 2011

First Posted Date

Jun 30, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2018

Last Update Posted Date

Jul 6, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Weekly Internet survey w medication	Experimental	Weekly survey via email plus topical triamcinolone	Behavioral: Weekly Internet survey Drug: Topical Triamcinolone
Topical triamcinolone only	Active Comparator	Standard of care	Drug: Topical Triamcinolone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Weekly Internet survey	Behavioral	Parents will complete a weekly online survey about medication use.	Weekly Internet survey w medication

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adherence to topical triamcinolone		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Eczema Area Severity Index		12 weeks
Investigator's Global Assessment		12 weeks

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

8 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven R Feldman, MD, PhD	Wake Forest University Health Sciences	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014221	Triamcinolone

Ancestor Terms

ID	Term
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided