Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DER 45 EV · 1 trial · 1 indication
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...
DER 45 EV is an investigational small molecule being developed for the treatment of rosacea, a chronic inflammatory skin condition. It is formulated as a topical gel and is currently in clinical development, having completed a Phase 2 trial.
DER 45 EV is being developed by Sol-Gel Technologies Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SLGL. The company is focused on dermatology treatments.
DER 45 EV is in Phase 2 of clinical development. A Phase 2 trial has been completed, and the drug remains investigational, meaning it is not yet approved by regulatory authorities such as the FDA.
DER 45 EV has been studied in one clinical trial, identified as NCT00940992, titled 'A Study of DER 45-EV Gel to Treat Rosacea.' This Phase 2, randomized, double-blind, placebo-controlled trial enrolled 92 participants in the United States and has been completed.
Yes, DER 45 EV and DER 45-EV refer to the same investigational drug. The clinical trial record uses the name 'DER 45-EV Gel,' while the drug is also referred to as DER 45 EV in development documentation.