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NCT03250663 · ClinicalTrials.gov registry record · Phase 1
Eucrisa for Atopic Dermatitis
A Phase 1 study of Mild to Moderate Atopic Dermatitis, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT03250663 is a Phase 1 study of Mild to Moderate Atopic Dermatitis that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 28 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03250663, a Phase 1 study of Mild to Moderate Atopic Dermatitis, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study 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 cap
Conditions Studied
Interventions
- BEHAVIORAL Online Treatment response
- DRUG EUCRISA
Study Locations (1)
North Carolina
- Wake Forest University Heath Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2017-10-01 |
| Est. Completion | 2022-07-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03250663
The ClinicalTrials.gov registry entry for NCT03250663 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Mild to Moderate Atopic Dermatitis appearing as the primary indexed condition, and to 2 interventions - of which Online Treatment response is the first listed.
NCT03250663 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT03250663 about?
NCT03250663 is a clinical study titled "Eucrisa for Atopic Dermatitis". 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®)...
What is the current status of trial NCT03250663?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2017-10-01. Estimated completion is 2022-07-27.
What conditions does trial NCT03250663 study?
This clinical trial studies the following conditions: Mild to Moderate Atopic Dermatitis.
What interventions are being tested in trial NCT03250663?
The interventions under investigation include: Online Treatment response (BEHAVIORAL), EUCRISA (DRUG).
Who is sponsoring clinical trial NCT03250663?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03250663 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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