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Also known as Econazole Nitrate Cream, 1%
Econazole Nitrate, 1% · 1 trial · 1 indication
To be considered a Therapeutic Cure, the patient must have both Clinical Cure (patient's total severity score must be ≤ 2 with no individual severity score \> 1) and Mycological Cure (patient must have a negative KOH test and a negative fungal culture) of tinea pedis
To be considered a Therapeutic Cure, the patient must have both Clinical Cure (patient's total severity score must be ≤ 2 with no individual severity score \> 1) and Mycological Cure (patient must have a negative KOH test and a negative fungal culture) of tinea pedis
| Arm | Type | Description |
|---|---|---|
| Test | EXPERIMENTAL | Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days |
| Reference Standard | ACTIVE_COMPARATOR | Econazole Nitrate Cream, 1%, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days |
| Placebo | PLACEBO_COMPARATOR | Placebo Cream, topical, sufficient amount to cover all affected areas on the feet once daily for 28 days |
| Name | Type | Description |
|---|---|---|
| Econazole Nitrate Cream, 1% | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Healthy male or non-pregnant, non-lactating female ≥ 18 years of age. * Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hype...
Econazole Nitrate, 1% is a topical cream being developed for the treatment of tinea pedis, commonly known as athlete's foot. It is an antifungal product in the infectious disease therapeutic area. The cream is applied to the affected skin area.
Econazole Nitrate Cream, 1% is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the development and regulatory submission of this topical antifungal product.
Econazole Nitrate, 1% is in Phase 3 clinical development. The program includes one completed Phase 3 trial. It is an investigational product and has not been approved by the FDA for the treatment of tinea pedis.
Econazole Nitrate, 1% has been studied in a completed Phase 3 trial, NCT03129321, titled Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis. The trial enrolled 876 participants and was randomized, double-blind, and placebo-controlled.
Yes, Econazole Nitrate, 1% and Econazole Nitrate Cream, 1% refer to the same product. The alternative name specifies the cream formulation. Both names are used interchangeably for the topical antifungal developed by Viatris Inc. for tinea pedis.