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Also known as Bifonazole cream 1%
Bifonazole 1% · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 2 | PLACEBO_COMPARATOR | - |
| Arm 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bifonazole cream 1% | DRUG | 1 squeeze of Bifonazole cream sufficient to cover the infected nail bed(s) with a thin layer once daily for 28 days after nail ablation with urea paste |
| Placebo cream | DRUG | 1 squeeze of Placebo cream sufficient to cover the infected nail bed(s) with a thin layer once daily for 28 days after nail ablation with urea paste |
Inclusion Criteria: * Age of at least 18 years; * Positive clinical findings of onychomycosis according to the judgement of the investigator (e.g. thickening, discoloration, structural changes, misshaped nails); * Positive mycological findings (positive microscopy and positive culture with identifi...
Bifonazole 1% is an investigational small molecule being studied for the treatment of onychomycosis, a fungal infection of the nails. It is applied as a topical cream. Development is in Phase 3, and the drug has not been approved for this use.
Bifonazole 1% is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor behind the clinical development program for this topical antifungal cream in onychomycosis.
Bifonazole 1% is in Phase 3 development for onychomycosis. One Phase 3 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved for the treatment of onychomycosis.
Bifonazole 1% has been evaluated in one completed Phase 3 trial, NCT00781820, titled Comparative Efficacy of Bifonazole Cream vs Placebo After Nail Ablation With Urea Paste. The randomized, double-blind, placebo-controlled study enrolled 693 adults with onychomycosis across Czechia, Germany, and Poland.
Yes. Bifonazole 1% and Bifonazole cream 1% refer to the same product, a topical cream formulation containing 1% bifonazole. The alternative name reflects the dosage form used in the onychomycosis development program.