The purpose of this research study is to better understand adherence to Locoid when people
use it to treat atopic dermatitis.
An investigator-blinded prospective study of subjects with mild to moderate atopic dermatitis
(>5% Body Surface area and 2 or 3 on the Investigator Global Assessment (IGA) scale). The
drug will be used within FDA-approved labeling. Subjects will be randomized to each of the
following topical hydrocortisone 17-butyrate 0.1% preparations— ointment, cream or lipocream—
in the manufacturer's original tube fitted with a Medication Event Monitoring System (MEMS)
cap. This cap records dates and times the assembly is opened and this data can be downloaded
and tabulated with the associated software.
The study will consist of a 2-week Treatment Phase (visits at Baseline and Week 2). Subjects
will be instructed to apply the medication twice daily (morning and evening) for 2 weeks to
all of their AD lesions.
Adherence will be measured by MEMs cap.
- Male or female ≥ 18 years of age.
- Subjects must have diagnosis of mild to moderate atopic dermatitis using IGA criteria.
(2 or 3 on severity scale)
- Subjects must have >5% TBSA and <30% to be enrolled.
- Women of child bearing potential will be allowed to participate in the study, and
these subjects will be required to use at least one form of birth control.
- Known allergy or sensitivity to topical Locoid® cream, ointment or lipocream in the
- Inability to complete all study-related visits.
- Introduction of any other prescription medication, topical or systemic, for atopic
dermatitis while participating in the study.
- Requiring >130 gm of cream in a 2 week period.
- Having facial or groin involvement of their disease.
- Pregnant women and women who are breast feeding are to be excluded. Women of child
bearing potential will be allowed to participate in the study, and these subjects will
be required to use at least one form of birth control.