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Also known as DFD-03 Lotion, 0.1%, DFD-03, DFD-03 (0.1% tazarotene) Lotion
DFD-03, 0.1% · 3 trials · 1 indication
Change in inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using a two way analysis of covariance (ANCOVA) model
Change in non-inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using the same ANCOVA model
IGA success at Week 12 (an IGA score of 0 (Clear) or 1 (almost clear) with at least a 2-grade reduction from baseline) - will be analyzed using the Cochran-Mantel-Haenszel (CMH) test for general association
IGA success at Week 12 (an IGA score of 0 (Clear) or 1 (almost clear) with at least a 2-grade reduction from baseline)
Frequency count of treatment emergent adverse events will be compared between DFD-03 Lotion and Tazorac Cream groups.
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | DFD-03 (0.1% tazarotene) Lotion |
| Vehicle | PLACEBO_COMPARATOR | Vehicle (0% tazarotene) Lotion |
| DFD-03 Lotion (0.1% tazarotene) | EXPERIMENTAL | DFD-03 Lotion (0.1% tazarotene) |
| DFD-03 Vehicle (0% tazarotene) | PLACEBO_COMPARATOR | DFD-03 Vehicle Lotion (0% tazarotene) |
| DFD-03 Lotion, 0.1% | EXPERIMENTAL | DFD-03 Lotion, 0.1% to be applied twice daily approximately 12 hours apart, for 1 minute and rinsed off |
| Tazorac Cream, 0.1% | ACTIVE_COMPARATOR | Tazorac Cream, 0.1% to be applied once in the evening and left overnight for approximately 12 hours |
| Vehicle Lotion | PLACEBO_COMPARATOR | Vehicle Lotion to be applied twice daily for 1 minute and rinsed off |
| Vehicle Cream | PLACEBO_COMPARATOR | Vehicle Cream to be applied once in the evening and left overnight for approximately 12 hours |
| Name | Type | Description |
|---|---|---|
| DFD-03 | DRUG | DFD-03 Lotion |
| Placebo Comparator | OTHER | Vehicle (tazarotene 0%) Lotion |
| DFD-03 (0.1% tazarotene) Lotion | DRUG | DFD-03 Lotion (0.1% tazarotene) - twice daily application |
| DFD-03 (0% tazarotene) Lotion (Placebo) | DRUG | DFD-03 Vehicle Lotion (0% tazarotene) - twice daily application |
| DFD-03 Lotion, 0.1% | DRUG | DFD-03 Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute. |
| Tazorac Cream, 0.1% | DRUG | Tazorac Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight. |
| DFD-03 Vehicle Lotion 0% | DRUG | Vehicle Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute. |
| Tazorac Vehicle Cream 0% | DRUG | Vehicle Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight. |
Main Inclusion Criteria: 1. Subject must be at least 9 years of age. 2. A clinical diagnosis of mild to moderate facial acne vulgaris. 3. Inflammatory lesion count (papules and pustules) of at least 20 on the face, Non-inflammatory lesion count (closed and open comedones) of at least 25 on the face...
DFD-03, 0.1% is an investigational topical lotion being developed for the treatment of acne vulgaris. It is applied to the skin and is being studied in patients aged 9 years and older. It has not been approved by the FDA and remains in clinical development.
DFD-03, 0.1% is being developed by Dr. Reddy's Laboratories Ltd, which trades on the New York Stock Exchange under the ticker RDY. The company is studying the lotion as a topical treatment for acne vulgaris in the United States.
DFD-03, 0.1% has completed Phase 3 clinical development. Three trials have been completed in total, including two Phase 3 studies and one Phase 2 study. No trials are currently active, and the drug is not FDA approved.
DFD-03, 0.1% has been studied in three completed trials: NCT03292640 and NCT03290027, both Phase 3 studies in acne vulgaris, and NCT03341910, a Phase 2 safety and local tolerability study. All three were conducted in the United States and enrolled 1,252 participants combined.
Yes. DFD-03, 0.1%, DFD-03 Lotion, 0.1%, DFD-03, and DFD-03 (0.1% tazarotene) Lotion all refer to the same investigational product. The names reflect the 0.1% tazarotene lotion formulation being developed by Dr. Reddy's Laboratories for acne vulgaris.
The DFD-03, 0.1% trials were randomized, double-blind, and placebo-controlled. The two Phase 3 studies, NCT03292640 and NCT03290027, enrolled 547 and 550 participants respectively, and the Phase 2 study NCT03341910 enrolled 155. Participants were 9 years and older, and enrollment was not biomarker selected.