Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tazarotene, 0.1% · 1 trial · 1 indication
The maximum plasma concentration of tazarotenic acid post dosing on Day 21 (Cmax(ss))
The Area Under the Curve time 0 to 24 hours (AUC0-24ss) of tazarotenic acid at steady state (Day 21)
Number of subjects with at least one TEAE from the time of signing the consent until the end of the study (Approximately 21 days).
| Arm | Type | Description |
|---|---|---|
| DFD-03 Lotion | EXPERIMENTAL | DFD-03 Lotion will be applied to the affected areas twice daily for 1 minute and rinsed off. 29 subjects will be enrolled into this arm. |
| Tazorac Cream | ACTIVE_COMPARATOR | Tazorac Cream will be applied to the affected areas once daily and left on for \~12 hours. 29 subjects will be enrolled into this arm. |
| Name | Type | Description |
|---|---|---|
| Tazarotene Lotion, 0.1% | DRUG | DFD-03 (Tazarotene Lotion, 0.1%) applied Twice Daily for 1 minute and rinsed off |
| Tazarotene Cream, 0.1% | DRUG | Tazorac® (tazarotene) Cream, 0.1% applied Once Daily and left for approximately 12 hours |
Inclusion Criteria: 1. Subject understands the study procedures, is willing to comply with the study procedures and required visits, and agrees to participate by giving written informed consent. Subjects under the legal age of consent must provide written assent and must have the written informed c...
Tazarotene 0.1% is a topical medication used for the treatment of moderate acne vulgaris. It is a small molecule being developed by Dr. Reddy's Laboratories Ltd. The drug is currently in Phase 2 clinical development for this dermatological condition.
Tazarotene is a retinoid that works by modulating gene expression in skin cells, though the specific molecular target is not disclosed in the available information. It is applied topically to treat acne vulgaris by affecting skin cell growth and differentiation.
Tazarotene 0.1% is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with moderate acne vulgaris.
Tazarotene 0.1% is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing development is focused on assessing its safety and effectiveness for treating moderate acne vulgaris.
Tazarotene 0.1% has one completed Phase 2 clinical trial registered under NCT03599193. This study, titled 'A Bioavailability Study of DFD-03 Compared to Tazorac® in Patients With Moderate Acne Vulgaris,' enrolled 58 participants in the United States. The trial was active-controlled and included patients aged 9 years and older.
Yes, Tazarotene 0.1% is also known as DFD-03. The clinical trial NCT03599193 refers to the drug as DFD-03, which is being compared to Tazorac® (a brand name for tazarotene) in patients with moderate acne vulgaris. Both names refer to the same investigational product.