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

Phase 4

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Male or female subjects age 2-15.
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 4.
Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.

Arm && Interventions

Group	Intervention	Description
Active Drug	tacrolimus ointment	tacrolimus ointment

Primary Outcome Measures

Name	Time	Method
Adherence	Week 4	adherence to topical therapy in children via MEMS cap in a "real-life" clinic population measured as the % of required applications completed

Secondary Outcome Measures

Name	Time	Method
EASI	Week 4	Eczema Area and Severity Index (EASI): Disease severity will be assessed by a physician with the Eczema Area and Severity Index (EASI). This measure is commonly used and well validated instrument of eczema severity. It is weighted for area in each of the four body regions (which differs for adults and children under 7) and scores erythema, excoriation, induration/papulation, and lichenification. The total scores range from 0-72. Higher scores represent more severe eczema.
The % Change From Baseline to Week 4 (or End of Treatment) in the IGA.	Week 4	Investigator Global Assessment: Investigator's Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick and simple way to quantify disease severity both for clinical studies and in a non-study clinic setting. Score ranges from '0' = clear or "No inflammatory signs of AD" to '4' = Very Severe Disease with "severe erythema and severe papulation/infiltration with oozing/crusting."