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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02445807 | A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis | PHASE3 | COMPLETED | 265 | — | — | Dec 1, 2015 | Jul 1, 2016 | May 15, 2018 | 30 | United States |
The primary efficacy endpoint is the percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at the Day 15 visit. The primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
| Arm | Type | Description |
|---|---|---|
| DFD-06 cream | EXPERIMENTAL | DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days. |
| Vehicle Cream | PLACEBO_COMPARATOR | Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days. |
| Name | Type | Description |
|---|---|---|
| DFD06-Cream | DRUG | Twice daily topical application for 14 days. |
| Vehicle Cream | DRUG | Twice daily topical application for 14 days. |
Inclusion Criteria: 1. Subject understands the study procedures and agrees to participate by giving written informed consent. Subjects must be willing to authorize use and disclosure of protected health information collected for the study. 2. Subject must be at least 18 years of age. 3. Subject mus...