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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03727074 | Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream With Efudex® (5-FU) Cream | PHASE3 | COMPLETED | 462 | — | — | Dec 21, 2018 | Dec 19, 2019 | Mar 18, 2020 | 1 | United States |
Proportion of subjects, in the Per-Protocol (PP) population, with treatment success, defined as complete clearing (100% clearance of all AK lesions within the designated treatment area) at the End of Study visit
| Arm | Type | Description |
|---|---|---|
| 5-FU Cream | EXPERIMENTAL | topical cream |
| Efudex® | ACTIVE_COMPARATOR | topical cream |
| Vehicle | PLACEBO_COMPARATOR | topical cream |
| Name | Type | Description |
|---|---|---|
| 5-FU Cream | DRUG | topical cream twice a day |
| Efudex® | DRUG | topical cream twice a day |
| Vehicle | DRUG | topical cream twice a day |
Inclusion Criteria: 1. Male and female 18 years of age and older. 2. Subject is able to understand and willing to sign Institutional Review Board (IRB) approved written informed consent for this study. 3. Subject must be generally healthy, based on medical records, and free from any clinically sign...