CLINICAL TRIALS PROFILE FOR CRISABOROLE
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All Clinical Trials for Crisaborole
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT03233529 ↗ | Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis | Completed | Pfizer | Phase 2 | 2017-07-31 | This study is being conducted to characterize the mechanism of action of crisaborole ointment 2%, by evaluation of efficacy and changes in key skin biomarkers in atopic dermatitis (AD) lesions treated with crisaborole ointment 2% over vehicle, in subjects with mild to moderate AD. Two identified AD skin lesions for each subject will be treated for the first 15 days, one with crisaborole ointment 2% and one with vehicle, in a blinded manner, and biopsies for biomarker analysis will be performed on the lesions. Following completion of the blinded treatment period, subjects will start the 28 day open label period during which all AD affected skin lesions will be treated with crisaborole ointment 2% twice daily. |
| NCT03250663 ↗ | Eucrisa for Atopic Dermatitis | Active, not recruiting | Wake Forest University Health Sciences | Phase 1 | 2017-10-01 | 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. |
| NCT03260595 ↗ | A Study of Crisaborole Ointment 2% in Adult Japanese Healthy Subjects and Adult Japanese Subjects With Mild To Moderate Atopic Dermatitis | Completed | Pfizer | Phase 1 | 2017-09-13 | This is a Phase 1 parallel-cohort study of crisaborole ointment 2% to evaluate the skin irritation potential in adult Japanese healthy subjects in Cohort 1, and to evaluate the safety, tolerability and PK in adult Japanese subjects with mild to moderate AD in Cohort 2. |
| NCT03351114 ↗ | Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea | Completed | Pfizer | Phase 2 | 2018-09-01 | This is a pilot study to determine the safety and clinical efficacy of crisaborole 2% ointment in the treatment of morphea. |
| NCT03351114 ↗ | Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea | Completed | Duke University | Phase 2 | 2018-09-01 | This is a pilot study to determine the safety and clinical efficacy of crisaborole 2% ointment in the treatment of morphea. |
| NCT03356977 ↗ | A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis | Completed | Pfizer | Phase 4 | 2018-01-16 | This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD. |
| NCT03539601 ↗ | A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD | Terminated | Pfizer | Phase 4 | 2018-04-27 | This 4-week study will evaluate the safety and efficacy of crisaborole ointment 2%; crisaborole vehicle; topical corticosteroid and topical calcineurin inhibitor, applied twice daily (BID) in subjects who are at least 2 years of age with mild-moderate AD. A Sub-Study of Optical Coherence Tomography and Biomarkers in Subjects ages 2 to <18 years old, with Mild to Moderate Atopic Dermatitis, treated with Crisaborole Ointment, 2% or Crisaborole Vehicle Ointment or Hydrocortisone Butyrate 0.1% Cream applied BID will also be conducted at select sites. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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