Eucrisa for Atopic Dermatitis

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences

Criteria

Inclusion Criteria:

• Male or female subjects age 2-64.

• 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 area.

• The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.

• The ability to understand and sign a written informed consent/assent form, which must be obtained prior to treatment.

Exclusion Criteria:

• Known allergy to crisaborole or to any component of the formulations.

• The use of systemic therapy for atopic dermatitis within the past 4 weeks.

• Use of prescription topical therapy for atopic dermatitis (e.g., corticosteroids or retinoids) within the past 2 weeks.

• Use of any investigational therapy within the past 4 weeks.

• 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 6 month and 12 month.

• Any other condition, which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.