Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for males and females aged 2-64 with mild to moderate atopic dermatitis covering 5% or more of their body. Participants must be able to follow the study procedures, provide consent, and not be using certain other treatments or have conditions that would increase risk.Inclusion Criteria
I can follow the study's procedures and attend all visits.
I am between the ages of 2 and 64.
The ability to understand and sign a written informed consent/assent form, which must be obtained prior to treatment
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Exclusion Criteria
I haven't used systemic therapy for eczema in the last 4 weeks.
I haven't used prescription skin creams for eczema in the last 2 weeks.
Any other condition, which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study
+3 more
Participant Groups
The effectiveness of Eucrisa (crisaborole) ointment in treating atopic dermatitis is being tested. Patients will apply it twice daily for a year, with usage monitored by special caps on the tubes. An online survey aims to improve adherence.
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2 - Online Treatment ResponseExperimental Treatment2 Interventions
Subjects receive study medication, EUCRISA (crisaborole) ointment 2%, and electronic treatment response emails
Group II: Arm 1 - Standard of CareActive Control1 Intervention
Subjects receive study medication, EUCRISA (crisaborole) ointment 2%, and follow standard of care
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wake Forest University Heath SciencesWinston-Salem, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor