An Investigator-blind, Randomized, Multicenter, 5-arm, Placebo- and Active Controlled Parallel Group Pilot Trial to Explore the Efficacy and Tolerability of Topical Bifonazole Liquid Spray in Patients With Athlete's Foot. (Porsche)

NCT01013909 Phase 2 COMPLETED

The study shall prove whether 6 consecutive doses of Bifonazole spray show comparable efficacy to a Terbinafine solution applied once.

Details

Lead sponsor	Bayer
Phase	Phase 2
Status	COMPLETED
Enrolment	220
Start date	2009-12
Completion	2010-05

Conditions

• Tinea Pedis

Interventions

• Bifonazole spray once daily
• Bifonazole spray twice daily
• Placebo
• Placebo
• Lamisil Once

Primary outcomes

• 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

Countries

Germany