Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04091087 | Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis | PHASE2 | COMPLETED | 66 | — | — | Jun 26, 2020 | Oct 19, 2021 | May 2, 2022 | 4 | United States |
TSS assesses severity of stasis dermatitis lesions. There were following 4 clinical signs of all treatable stasis dermatitis lesions: erythema, papulation/elevation, superficial erosion/denudation, and scaling. Each of 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). TSS = sum of scores from all clinical signs; ranging from 0 (none) to 12 (most severe), where higher score indicated greater severity. The assessment was completed in person by the home visit practitioner.
| Arm | Type | Description |
|---|---|---|
| crisaborole ointment | EXPERIMENTAL | crisaborole ointment |
| vehicle ointment | SHAM_COMPARATOR | vehicle ointment |
| Name | Type | Description |
|---|---|---|
| crisaborole ointment | DRUG | crisaborole ointment |
| vehicle ointment | OTHER | vehicle ointment |
Inclusion Criteria: * Participants who are ≥45 years of age and in generally stable health * Participants who are in generally stable health and have a known diagnosis of Stasis Dermatitis or newly diagnosed Stasis Dermatitis * Participants whose mental and physical status allows them to be able to...