Trial Condition(s):

Tinea Pedis

Comparative safety and efficacy study of new Bifonazol spray vs Terbinafine solution vs placebo (Porsche)

Bayer Identifier:

13957

ClinicalTrials.gov Identifier:

NCT01013909

EudraCT Number:

2008-005654-21

Study Completed

Trial Purpose

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

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

Trial Summary

Enrollment Goal
220
Trial Dates
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Phase
2
Could I receive a placebo?
Yes
Products
Bifonazole (BAYH4502)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Praxis Hr. Dr. K.-G. Meyer

Berlin, Germany, 10437

Status
Completed
 
Locations

Praxis Hr. Dr. T. Wildfeuer

Berlin, Germany, 13055

Status
Completed
 
Locations

Praxis Hr. Dr. P. Uhl

Berlin, Germany, 13439

Status
Completed
 
Locations

Praxis Fr. Dr. med. E. Zahn

Berlin, Germany, 13187

Status
Completed
 

Trial Design