Patients with mild to moderate atopic dermatitis will be asked to participate in helping the
study team determine how well the medication works for atopic dermatitis. Participants will
not be told that adherence will be monitored. Patients will be dispensed topical crisaborole
2% ointment (Eucrisa®) in a medication tube fitted with a Medication Event Monitoring System
(MEMS) cap if they agree to participate. This cap records dates and times the bottle is
opened and this data can be downloaded and tabulated with the associated software.
Investigators and subjects will be blinded to the adherence data until the final treatment
(12 month) session. The study subjects will be randomized to two groups. After baseline
visit, both groups will come for a follow-up visit at 1 month, 3 months, 6 months, and 12
months. The intervention group will also be asked to complete an online treatment response
survey designed to improve adherence at weekly intervals for 6 weeks, then monthly
thereafter.
The study will consist of a 12-month Treatment Phase. Study subjects will be instructed to
apply the medication twice daily (morning and evening) to all of their AD lesions. They will
be instructed to apply the smallest amount of study medication possible that is sufficient to
cover all lesions. These instructions are standard-of-care for patients with AD.
Subjects will be asked to bring their medication tubes with them at each visit. At each
visit, the study coordinator will weigh the medication tube and download the MEMS cap data.
Disclosure of the adherence monitoring will occur at the 12 month visit (or end of
treatment), at which time the results of the subject's adherence behavior will be used to
supply individualized treatment options for each subject (feedback session).
At each visit, drug tubes will be measured for weight to determine the amount of study
medication used. This data will be correlated with the extent of BSA involved and the
response of the disease. The MEMS caps will be downloaded at each visit.