Trial Condition(s):

Onychomycosis

Comparative efficacy of Bifonazole cream vs placebo after nail ablation with urea paste

Bayer Identifier:

12999

ClinicalTrials.gov Identifier:

NCT00781820

EudraCT Number:

2008-003215-13

Study Completed

Trial Purpose

The study is focused to prove that the efficacy of a 1% Bifonazole cream is superior to a placebo cream after non-surgical nail ablation with a 40% urea paste.

Inclusion Criteria
- Age of at least 18 years;
 - Positive clinical findings of onychomycosis according to the judgement of the investigator (e.g. thickening, discoloration, structural changes, misshaped nails);
 - Positive mycological findings (positive microscopy and positive culture with identification of pathogen) in material taken from affected nail sites before the start of treatment;
 - Nail mycosis with an affected nail area between 20% and 50% in the target nail,
 - Nail mycosis in not more than 3 nails (each nail not more than 50% infected area)
Exclusion Criteria
- Doubtful or negative mycological findings;
 - Proximal subungual onychomycosis (PSO);
 - Topical antimycotic treatment of feet or hands within 4 weeks prior to screening, topical  treatment of onychomycosis of feet or hands within 12 weeks prior to screening;
 - Systemic antimycotic treatment within 12 weeks prior to screening;
 - Failure to treat tinea pedis/manus (diagnosed  at screening) successfully with topical  treatment between screening visit and visit 1 (baseline);
 - Tinea pedis/manus at visit 1 (baseline);
 - Uncontrolled diabetes mellitus
 - Psoriasis
 - Peripheral arterial disease
 - Chronic venous insufficiency;
 - Diabetic neuropathy;
 - History of hypersensitivity to bifonazole, or any other similar pharmacological agents or components of the products;
 - Known sensitivity to plasters.

Trial Summary

Enrollment Goal
693
Trial Dates
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Phase
3
Could I receive a placebo?
Yes
Products
Mycospor/Canesten Extra (Bifonazole, BAYH4502)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Universitätsklinikum Aachen

Aachen, Germany, 52074

Status
Completed
 
Locations

Praxis Hr. Dr. G. Esterle

Dresden, Germany, 01277

Status
Completed
 
Locations

Praxis Fr. Dr. B. Gerlach

Dresden, Germany, 01097

Status
Completed
 
Locations

Praxis Fr. Dr. M. Lübke

Berlin, Germany, 10369

Status
Completed
 
Locations

Praxis Dr. Hr. Dr. Florian Garbe

Berlin, Germany, 13597

Status
Completed
 
Locations

Praxis Fr. Dr. med. R. Pels

Berlin, Germany, 12157

Status
Completed
 
Locations

Praxis Hr. Dr. H. Prés

Berlin, Germany, 10435

Status
Completed
 
Locations

Praxis Hr. Dr. T. Wildfeuer

Berlin, Germany, 13055

Status
Completed
 
Locations

Praxis Fr. Dr. med. E. Zahn

Berlin, Germany, 13187

Status
Completed
 
Locations

Praxis Hr. Dipl. med. Ridwan Weber

Augsburg, Germany, 86163

Status
Completed
 
Locations

Praxis Fr. Dr. med. Marianne Lochno

Löbau, Germany, 02708

Status
Completed
 
Locations

Praxis Hr. Prof. Dr. med. Jürgen Weiß

Hannover, Germany, 30159

Status
Completed
 
Locations

Praxis Hr. Dr. med. Abdou Zarzour

Halle, Germany, 06108

Status
Completed
 
Locations

Praxis Hr. Dr. Martin Kuppinger

Potsdam, Germany, 14482

Status
Completed
 
Locations

Praxis Hr. PD Dr. T. Dirschka

Wuppertal, Germany, 42275

Status
Completed
 
Locations

Praxis Hr. Dr. T.-M. Ernst

Berlin, Germany, 13437

Status
Completed
 
Locations

Praxis Hr. Dr. K.-G. Meyer

Berlin, Germany, 10437

Status
Completed
 
Locations

Praxis Hr. Dr. P. Uhl

Berlin, Germany, 13439

Status
Completed
 
Locations

Praxis Fr. Dr. Sabine Fischer

Leipzig, Germany, 04315

Status
Completed
 
Locations

Praxis Fr. Dr. M. Simon

Berlin, Germany, 10827

Status
Completed
 
Locations

Praxis Hr. Dr. G. Popp

Augsburg, Germany, 86179

Status
Completed
 
Locations

Praxis Fr. Dr. K. Weis

Reichenbach, Germany, 08468

Status
Completed
 
Locations

Gemeinschaftspraxis Dr.med. M. Miehe/PD Dr.med. U. Serfling

Berlin, Germany, 13507

Status
Completed
 
Locations

Praxis Fr. Dr. med. Emilia Ponce de Pöschl

Oberschleißheim, Germany, 85764

Status
Completed
 
Locations

Praxis Hr. Dr. med. Adrian Roye

Murnau, Germany, 82418

Status
Completed
 
Locations

Praxis Hr. Dr. med. Wilfried Steinborn

Straubing, Germany, 94315

Status
Completed
 
Locations

Praxis Fr. Dr. Britta Fordran

Chemnitz, Germany, 09117

Status
Completed
 
Locations

Praxis Fr. Dr. med. Andrea Gräfe

Northeim, Germany, 37154

Status
Completed
 
Locations

SCIderm GmbH

Hamburg, Germany, 20354

Status
Completed
 
Locations

Hautzentrum Dülmen Drs. Bockhorst & Dominicus

Dülmen, Germany, 48249

Status
Completed
 
Locations

Praxis Hr. Dr. G. Falker

Frankenberg, Germany, 35066

Status
Completed
 
Locations

Praxis Fr. Dr. E. Thomas

Marburg, Germany, 35037

Status
Completed
 
Locations

Gabinet Dermatologiczno-Kosmetyczny

Bialystok, Poland, 15-660

Status
Completed
 
Locations

Gabinet Dermatologiczny dr Joanna Kolinek

Pruszkow, Poland, 05-800

Status
Completed
 
Locations

NZOZ Dermatologia

Olsztyn, Poland, 10-501

Status
Completed
 
Locations

Dr. Korandova

Olomouc, Czech Republic, 77900

Status
Completed
 
Locations

Dr. Ivona Zikova

Louny, Czech Republic, 44001

Status
Completed
 
Locations

Dr. Jaroslav Dragon

Usti nad Labem, Czech Republic, 40010

Status
Completed
 
Locations

Dr. Sonja Lacinova

Chomutov, Czech Republic, 43012

Status
Completed
 
Locations

Poliklinika Dermatologic Department

Kutna Hora, Czech Republic, 28401

Status
Completed
 
Locations

Dermatologicka ambulance

Hlinsko, Czech Republic, 539 01

Status
Completed
 
Locations

Praxis Fr. Dr. C. Weidner

Gera, Germany, 07551

Status
Completed
 
Locations

Praxisgemeinschaft Aschoffplatz

Freiburg, Germany, 79104

Status
Completed
 
Locations

Praxis Hr. Dr. D.Lichtenthaeler

Lübeck, Germany, 23558

Status
Completed
 
Locations

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland, 80-952

Status
Completed
 
Locations

Indywidualna Specjalistyczna Praktyka Lekarska

Gdansk, Poland, 80-177

Status
Completed
 
Locations

SP Szpital Kliniczny Nr.1

Wroclaw, Poland, 50-369

Status
Completed
 
Locations

Kozni ordinace

Praha, Czech Republic, 15500

Status
Completed
 
Locations

Dr. Sekerova

Slany, Czech Republic, 27401

Status
Completed
 
Locations

Dr. Trestik

Svitavy, Czech Republic, 56802

Status
Completed
 
Locations

Dermatologicka ambulance

Rychnov nad Kneznou, Czech Republic, 516 01

Status
Completed
 

Trial Design