Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DFD06 · 2 trials · 1 indication
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. Primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
HPA axis suppression as measured by serum cortisol levels post cosyntropin test (ACTH test)
| 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. |
| Clobetasol Propionate Cream, 0.05% | ACTIVE_COMPARATOR | applied twice a day for 15 days |
| DFD06 Cream | EXPERIMENTAL | applied twice a day for 15 days |
| Name | Type | Description |
|---|---|---|
| DFD06 Cream | DRUG | Twice daily topical application for 14 days. |
| Vehicle Cream | DRUG | Twice daily topical application for 14 days. |
| Clobetasol Propionate Cream 0.05% | DRUG | - |
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...