Recent Updates
Recently added Catalysts

Bifonazole once daily

Phase 2

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

Bifonazole once daily target and mechanism

ModalitySmall molecule

Also known as Bifonazole spray once daily

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment220

FDA Designations

No designations recorded

Bifonazole once daily clinical trials

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)
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about Bifonazole once daily

What is bifonazole once daily used for?

Bifonazole once daily is an investigational topical treatment being studied for tinea pedis, commonly known as athlete's foot. It is a small molecule antifungal developed by Bayer AG. The formulation is designed for once-daily application to the affected skin area.

Who makes bifonazole once daily?

Bifonazole once daily is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the sponsor of the clinical program evaluating this topical antifungal formulation for tinea pedis.

What phase is bifonazole once daily in?

Bifonazole once daily is in Phase 2 clinical development for tinea pedis. It is investigational and has not been approved by the FDA for this use. The program includes one completed Phase 2 trial, with no active trials currently listed.

What clinical trials is bifonazole once daily in?

Bifonazole once daily was evaluated in the completed Phase 2 trial NCT01013909, titled Comparative Safety and Efficacy Study of New Bifonazol Spray vs Terbinafine Solution vs Placebo. The trial enrolled 220 participants in Germany, was randomized and placebo-controlled, and included adults 18 years and older of all sexes.

Is bifonazole once daily the same as bifonazole spray once daily?

Yes, bifonazole once daily is also known as bifonazole spray once daily. Both names refer to the same Bayer AG topical antifungal product candidate being studied for tinea pedis. The spray formulation is the dosage form used in the Phase 2 trial.

How does bifonazole once daily work?

Bifonazole once daily is a small molecule antifungal. It is applied topically as a spray to treat tinea pedis, a fungal infection of the feet. The once-daily dosing schedule is intended to simplify treatment compared with more frequent application regimens.