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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00940992 | A Study of DER 45-EV Gel to Treat Rosacea | PHASE2 | COMPLETED | 92 | — | — | Jan 1, 2012 | Jan 1, 2013 | Jan 9, 2015 | 10 | United States |
The proportions of subjects with the primary measure of success at week 12 /end of study ,defined as a 2-grade improvement in the IGA (Investigator Global Assessment) relative to Baseline. The Investigator Global Assessment grades are: Grade 0 (Clear), Grade 1 (Almost Clear), Grade 2 (Mild), Grade 3 (Moderate) and Grade 4 (Severe).
The LS mean changes from Baseline in inflammatory lesion count at Week 12.
| Arm | Type | Description |
|---|---|---|
| DER 45 EV Gel, 1% | EXPERIMENTAL | DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks |
| Vehicle | PLACEBO_COMPARATOR | Placebo Gel applied topically once a day for 12 weeks |
| DER 45 EV Gel, 5% | EXPERIMENTAL | DER 45 EV Gel, 5% applied topically once a day for 12 weeks |
| Name | Type | Description |
|---|---|---|
| DER 45 EV | DRUG | Topical application to face for 12 weeks |
| Vehicle | DRUG | Topical application to face for 12 weeks |
Inclusion Criteria: * Males and females, 18 years of age or older * Facial rosacea, with 12 or more inflammatory lesions (with no more than 2 nodules) * Mild, Moderate or Severe (2, 3 or 4) rating of rosacea on the IGA * Females of child-bearing potential must have negative urine pregnancy test res...