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Also known as DFD06 Cream
DFD06 · 3 trials · 2 indications
The primary efficacy endpoint is the percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at the Day 15 visit. The primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
The percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2-grade reduction from baseline) at the Day 15 visit. Primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
HPA axis suppression as measured by serum cortisol levels post cosyntropin test (ACTH test)
| Arm | Type | Description |
|---|---|---|
| DFD-06 cream | EXPERIMENTAL | DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days. |
| Vehicle Cream | PLACEBO_COMPARATOR | Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days. |
| Clobetasol Propionate Cream, 0.05% | ACTIVE_COMPARATOR | applied twice a day for 15 days |
| DFD06 Cream | EXPERIMENTAL | applied twice a day for 15 days |
| Name | Type | Description |
|---|---|---|
| DFD06-Cream | DRUG | Twice daily topical application for 14 days. |
| Vehicle Cream | DRUG | Twice daily topical application for 14 days. |
| DFD06 Cream | DRUG | Twice daily topical application for 14 days. |
| Clobetasol Propionate Cream 0.05% | DRUG | - |
Inclusion Criteria: 1. Subject understands the study procedures and agrees to participate by giving written informed consent. Subjects must be willing to authorize use and disclosure of protected health information collected for the study. 2. Subject must be at least 18 years of age. 3. Subject mus...
DFD06 is an investigational small molecule cream being developed by Dr. Reddy's Laboratories Ltd for the treatment of chronic stable plaque psoriasis and psoriasis. It is a topical therapy applied directly to affected skin and has been studied in Phase 3 clinical trials in the United States.
DFD06 is being developed for the treatment of moderate to severe plaque psoriasis, including chronic stable plaque psoriasis. It is a topical cream intended for direct application to psoriatic skin lesions. The program has completed Phase 3 trials but has not been approved for marketing.
DFD06 is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is the sponsor of the clinical development program for DFD06 Cream.
DFD06 is in Phase 3 clinical development. Two Phase 3 trials have been completed, and the drug remains investigational. It has not been approved by the FDA for any indication.
DFD06 has been studied in completed trials including NCT02635204 and NCT02445807, both Phase 3 studies of DFD06 Cream in moderate to severe plaque psoriasis, and NCT02131324, a Phase 2 HPA axis suppression study comparing DFD06 Cream with clobetasol propionate cream 0.05%. All trials were conducted in the United States.
Yes, DFD06 is also known as DFD06 Cream and DFD06-Cream. These names refer to the same investigational topical small molecule product developed by Dr. Reddy's Laboratories Ltd for plaque psoriasis.