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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05343455 | A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2) | PHASE3 | COMPLETED | 330 | — | — | Mar 29, 2022 | Jun 30, 2023 | Dec 3, 2024 | 24 | United States, Germany |
| NCT05296629 | A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea. | PHASE3 | COMPLETED | 323 | — | — | Mar 14, 2022 | Jun 30, 2023 | Dec 3, 2024 | 27 | United States |
Proportion of subjects with IGA (modified scale without erythema) 'treatment success' - Grade 0 or 1 at Week 16 with at least 2 grade reduction from Baseline to Week 16, in the DFD-29 group compared to Placebo. The modified IGA scale is a 5-point scale from Grade 0 to Grade 4, wherein Grade 0 is Clear, Grade 1 is Near Clear, Grade 2 is Mild, Grade 3 is Moderate and Grade 4 is Severe Rosacea. A lowering of the score with treatment indicates an improvement in the disease condition and a beneficial outcome.
Total inflammatory lesion count (sum of papules, pustules, and nodules) change from Baseline to Week 16, in the DFD-29 group compared to Placebo.
| Arm | Type | Description |
|---|---|---|
| DFD-29 | EXPERIMENTAL | DFD-29 (40 mg) extended release capsules |
| Doxycycline 40 mg | ACTIVE_COMPARATOR | Doxycycline 40 mg modified release capsules |
| Placebo | PLACEBO_COMPARATOR | Placebo capsules matching DFD-29 |
| Name | Type | Description |
|---|---|---|
| DFD-29 | DRUG | DFD-29 (40 mg) extended release capsules |
| Doxycycline | DRUG | Doxycycline 40 mg capsules |
| Placebo | DRUG | Placebo capsules |
Key Inclusion Criteria: * Male and female subjects aged 18 years and above. * Subjects must be in good general health as determined by the investigator and supported by the medical history. * Subjects must have a clinical diagnosis of papulopustular rosacea with IGA grade 3 (moderate) or IGA grade ...