Measuring Adherence to Topical Therapy in Children With Atopic Dermatitis and the Impact of a Return Visit

Wake Forest University1 site in 1 country30 target enrollmentApril 2008

ConditionsAtopic Dermatitis

Interventionstacrolimus ointment

Drugstacrolimus ointment

Overview

Phase: Phase 4
Intervention: tacrolimus ointment
Conditions: Atopic Dermatitis
Sponsor: Wake Forest University
Enrollment: 30
Locations: 1
Primary Endpoint: Adherence
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this research study is to better understand how the study drug works when people use it to treat atopic dermatitis.

Detailed Description

To evaluate adherence to topical therapy using adherence data collected by the MEMS cap (Medication Electronic Monitoring System) in pediatric patients with atopic dermatitis (AD) and the impact of a return visit.

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

September 2009

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Wake Forest University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female subjects age 2-
•Stable or worsening atopic dermatitis affecting 5% or greater body surface area. Face and genital areas can be included in the body surface area determination and treatment area.
•The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
•The ability to understand and sign a written informed consent/assent form, which must be obtained prior to treatment.

Exclusion Criteria

•Known allergy to tacrolimus or to any component of the formulations.
•The use of systemic therapy for atopic dermatitis within the past 4 weeks.
•Use of prescription topical therapy for atopic dermatitis (e.g., corticosteroids or retinoids) within the past 2 weeks.
•Use of any investigational therapy within the past 4 weeks.
•Pregnant females, females who are breast feeding, or females of childbearing potential who are not practicing an acceptable method of birth control (abstinence, birth control pill/patch, barrier with spermicidal jelly, IUD, etc.), as determined by the investigator. Acceptable contraception must be used during the entire study. A pregnancy test will be performed on females of childbearing potential at baseline and at week
•Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.