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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02828241 | A Study to Assess the Efficacy, Safety and Tolerability of DFD-04 | PHASE2 | COMPLETED | 61 | — | — | Jul 1, 2016 | Nov 1, 2017 | Jan 23, 2019 | 8 | Germany |
Mean change from Baseline in the inflammatory lesion count at the End of Treatment. A lower score at the end of the study compared to Baseline is considered a better outcome.
Number of subjects with treatment success based on Investigator's Global Assessment (IGA) score at the End of Treatment, defined as an IGA score of 0 (clear) or 1 (almost clear) with composite grade change from Baseline of at least 2 points.
Number of subjects with Treatment Success defined as a score of 0 or 1 and a 2 grade improvement on the CEA scale from Baseline to 12 weeks.
| Arm | Type | Description |
|---|---|---|
| DFD-04 Ointment | EXPERIMENTAL | DFD-04 (Itraconazole) Ointment |
| Placebo Ointment | PLACEBO_COMPARATOR | Placebo Ointment |
| Name | Type | Description |
|---|---|---|
| DFD-04 Ointment | DRUG | - |
| Placebo Ointment | OTHER | - |
Inclusion Criteria: 1. Subjects must be able to understand the requirements of the study and be willing to give written informed consent. 2. Subjects must be willing to provide authorization to use protected health information. 3. Subjects, any gender or race, must be in good general health as dete...