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.
1. Male or female subjects age 2-15.
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
3. The ability and willingness to follow all study procedures, attend all scheduled
visits, and successfully complete the study.
4. The ability to understand and sign a written informed consent/assent form, which must
be obtained prior to treatment.
1. Known allergy to tacrolimus or to any component of the formulations.
2. The use of systemic therapy for atopic dermatitis within the past 4 weeks.
3. Use of prescription topical therapy for atopic dermatitis (e.g., corticosteroids or
retinoids) within the past 2 weeks.
4. Use of any investigational therapy within the past 4 weeks.
5. 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.
6. Any other condition which, in the judgment of the investigator, would put the subject
at unacceptable risk for participation in the study.