The purpose of this research study is to better understand how the study drug works when people use it to treat atopic dermatitis.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
tacrolimus ointment to be applied twice daily to affected areas during duration of study
Dept of Dermatology, WFUHS
Winston-Salem, North Carolina, United States
Adherence
adherence to topical therapy in children via MEMS cap in a "real-life" clinic population measured as the % of required applications completed
Time frame: Week 4
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."
Time frame: 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.
Time frame: Week 4
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