Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DFD-04 · 1 trial · 1 indication
Mean change from Baseline in the inflammatory lesion count at the End of Treatment. A lower score at the end of the study compared to Baseline is considered a better outcome.
Number of subjects with treatment success based on Investigator's Global Assessment (IGA) score at the End of Treatment, defined as an IGA score of 0 (clear) or 1 (almost clear) with composite grade change from Baseline of at least 2 points.
Number of subjects with Treatment Success defined as a score of 0 or 1 and a 2 grade improvement on the CEA scale from Baseline to 12 weeks.
| Arm | Type | Description |
|---|---|---|
| DFD-04 Ointment | EXPERIMENTAL | DFD-04 (Itraconazole) Ointment |
| Placebo Ointment | PLACEBO_COMPARATOR | Placebo Ointment |
| Name | Type | Description |
|---|---|---|
| DFD-04 Ointment | DRUG | - |
| Placebo Ointment | OTHER | - |
Inclusion Criteria: 1. Subjects must be able to understand the requirements of the study and be willing to give written informed consent. 2. Subjects must be willing to provide authorization to use protected health information. 3. Subjects, any gender or race, must be in good general health as dete...
DFD-04 is an investigational small molecule being developed for the treatment of rosacea, a chronic inflammatory skin condition. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied for its efficacy, safety, and tolerability in patients with rosacea.
DFD-04 is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker symbol RDY. The company is conducting clinical trials to evaluate the drug's potential as a treatment for rosacea.
DFD-04 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies. The Phase 2 trial has been completed, and the drug is being evaluated for its efficacy, safety, and tolerability in patients with rosacea.
DFD-04 has one completed Phase 2 clinical trial registered under NCT02828241, titled "A Study to Assess the Efficacy, Safety and Tolerability of DFD-04." The trial enrolled 61 participants with rosacea in Germany and was a randomized, double-blind, placebo-controlled study.
DFD-04 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of rosacea. The drug has completed a Phase 2 trial, but it has not yet received regulatory approval from the FDA or any other health authority.