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Bifonazole once daily

Phase 2

Tinea Pedis | Small molecule | Infectious Disease |Bayer AG|Last Updated: Jan 27, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment220

FDA Designations

No designations recorded

Clinical trial landscape

Bifonazole once daily · 1 trial · 1 indication

Phase 2 1
NCT01013909Comparative Safety and Efficacy Study of New Bifonazol Spray vs Terbinafine Solution vs PlaceboTinea Pedis
COMPLETED220 Analytics
PHASE2COMPLETED
Comparative Safety and Efficacy Study of New Bifonazol Spray vs Terbinafine Solution vs Placebo
Tinea PedisUnlock trial analytics

Study Endpoints

Primary Endpoints

Assessment of erythema, scaling, vesiculation maceration, and pruritus based on a categorial scale (0=absent to 3 =severe), assessment of mycological cure based on cultures and microscopy
After 6 applications (7 and 42 days after start of treatment)
Local side effects on the skin
From day 1 through day 42

Secondary Endpoints

Clinical cure
After 6 applications (7 and 42 days after start of treatment)
Mycological cure
After 6 applications (7 and 42 days after start of treatment)
Rate of negative culture
After 6 applications (7 and 42 days after start of treatment)
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -
Arm 3PLACEBO_COMPARATOR -
Arm 4PLACEBO_COMPARATOR -
Arm 5ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Bifonazole spray once dailyDRUGApplication of one dose daily by means of an metered dose
Bifonazole spray twice dailyDRUGApplication of two dose daily by means of an metered dose
PlaceboDRUGApplication of one dose daily by means of an metered dose
Lamisil OnceDRUGOne application of Lamisil Once
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Male or female subjects aged between 18 and 70 years * Positive clinical findings of athlete's foot, limited to interdigital spaces, with a total athlete's foot severity score (AFSS) of at least 5 and not exceeding 10 points for the signs and symptoms of athlete's foot, and no...

Countries:Germany
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Frequently asked questions about Bifonazole once daily

What is Bifonazole once daily used for?

Bifonazole once daily is an investigational small molecule being studied for the treatment of Tinea Pedis, a fungal infection of the feet. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

What does Bifonazole once daily target?

Bifonazole once daily is an antifungal agent. It is being evaluated for its efficacy and safety in treating Tinea Pedis, a common fungal skin infection. The specific molecular target of this drug has not been disclosed in the available clinical trial information.

Who makes Bifonazole once daily?

Bifonazole once daily is being developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY on the OTC market.

What phase is Bifonazole once daily in?

Bifonazole once daily is in Phase 2 clinical development. It is an investigational drug and has not yet received regulatory approval. The drug is being studied for the treatment of Tinea Pedis.

What clinical trials is Bifonazole once daily in?

Bifonazole once daily has one completed Phase 2 clinical trial, NCT01013909, titled 'Comparative Safety and Efficacy Study of New Bifonazol Spray vs Terbinafine Solution vs Placebo'. This randomized, placebo-controlled trial enrolled 220 participants with Tinea Pedis in Germany.

Is Bifonazole once daily the same as Bifonazole?

Bifonazole once daily is a formulation of bifonazole, an antifungal medication. The 'once daily' designation indicates the intended dosing frequency. In clinical trials, it is being studied as a spray formulation for the treatment of Tinea Pedis.