Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as DFD-04 Ointment
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 topical therapy being developed for the treatment of rosacea, a chronic inflammatory skin condition. It is formulated as an ointment and is being studied by Dr. Reddy's Laboratories Ltd. DFD-04 is not yet approved and remains in clinical development.
DFD-04 is being evaluated for the treatment of rosacea, a dermatologic condition characterized by facial redness and inflammation. Its development focuses on assessing efficacy, safety, and tolerability in adults with rosacea. The drug is investigational and has not been approved for any indication.
DFD-04 is being developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is the sponsor of the clinical program evaluating the ointment in rosacea.
DFD-04 is in Phase 2 clinical development for rosacea. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not received regulatory approval for any indication.
DFD-04 has been studied in one completed Phase 2 trial, NCT02828241, titled a study to assess the efficacy, safety and tolerability of DFD-04. The trial enrolled 61 participants with rosacea in Germany, was randomized, double-blind, and placebo-controlled, and included adults aged 18 years and older.
Yes, DFD-04 Ointment is another name for DFD-04. Both refer to the same investigational topical small molecule developed by Dr. Reddy's Laboratories Ltd for rosacea. The ointment formulation is the version evaluated in the completed Phase 2 trial.