NCT01385527

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2014

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

3.4 years

First QC Date

June 28, 2011

Last Update Submit

July 3, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adherence to topical triamcinolone

    12 weeks

Secondary Outcomes (2)

  • Eczema Area Severity Index

    12 weeks

  • Investigator's Global Assessment

    12 weeks

Study Arms (2)

Weekly Internet survey w medication

EXPERIMENTAL

Weekly survey via email plus topical triamcinolone

Behavioral: Weekly Internet surveyDrug: Topical Triamcinolone

Topical triamcinolone only

ACTIVE COMPARATOR

Standard of care

Drug: Topical Triamcinolone

Interventions

Parents will complete a weekly online survey about medication use.

Weekly Internet survey w medication

Topical triamcinolone to all affected areas once daily

Topical triamcinolone onlyWeekly Internet survey w medication

Eligibility Criteria

Age2 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Steven R Feldman, MD, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2011

First Posted

June 30, 2011

Study Start

June 1, 2011

Primary Completion

October 27, 2014

Study Completion

October 27, 2014

Last Updated

July 6, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share