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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03340961 | A Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules | PHASE2 | COMPLETED | 205 | — | — | Oct 1, 2017 | Mar 31, 2019 | Mar 1, 2021 | 14 | Germany |
Proportion of subjects with Investigator Global Assessment (IGA) 'treatment success' - Grade 0 or 1 at the end of study with at least 2 grade reduction from Baseline to Week 16.
The total inflammatory lesion count is carried out by visual inspection by the Investigator at every study visit from Screening up to Week 16 (or at early termination). Inflammatory lesions will be recorded on a diagram of a human face, divided in 4 quadrants.
| Arm | Type | Description |
|---|---|---|
| DFD-29 Extended Release Capsules (40 mg) | EXPERIMENTAL | DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks. |
| DFD-29 Extended Release Capsules (20 mg) | EXPERIMENTAL | DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks. |
| Oraycea® (doxycycline) Capsules | EXPERIMENTAL | Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks. |
| Placebo Capsules | PLACEBO_COMPARATOR | Placebo Capsules once per day for 16 weeks. |
| Name | Type | Description |
|---|---|---|
| DFD-29 Extended Release Capsules (40 mg) | DRUG | Oral Treatment |
| DFD-29 Extended Release Capsules (20 mg) | DRUG | Oral Treatment |
| Oraycea® (doxycycline) Capsules | DRUG | Oral Treatment |
| Placebo Capsules | DRUG | Oral Treatment |
Inclusion Criteria: 1. Subjects must be able to understand the requirements of the study and be willing to give written informed consent. 2. Male and female subjects aged 18 years and above. 3. Subjects, any gender or ethnicity (and of Fitzpatrick skin type I - III), must be in good general health ...