Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DFD-29 · 2 trials · 1 indication
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 ...