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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: tacrolimus ointment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Drug<br>tacrolimus ointment | Drug: tacrolimus ointment<br>* tacrolimus ointment to be applied twice daily to affected areas during duration of study<br>* Other names: Protopic Ointment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | adherence to topical therapy in children via MEMS cap in a real-life clinic population measured as the % of required applications completed | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The % Change From Baseline to Week 4 (or End of Treatment) in the IGA. | 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. | Week 4 | 
| EASI | 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. | Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atopic dermatitis, eczema