Comparative Safety and Efficacy Study of New Bifonazol Spray vs Terbinafine Solution vs Placebo

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Bifonazole; Terbinafine

Criteria

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 sign or symptom scoring 'severe'

Exclusion Criteria:

• Clinical history suggestive of intolerance or allergies to one of the products or the ingredients of the products

• Plantar tinea pedis ("Mocassin-type")

• Onychomycosis of any toe

• Previous treatment with a systemic antifungal within 6 months prior to screening

• Previous treatment of feet with a topical antifungal within 4 weeks prior to screening

• Previous treatment with a topical antifungal applied to other areas of the body than feet within 2 weeks prior to screening

• Previous treatment of any topical medication applied to the feet within 2 weeks prior to screening