Trial Condition(s):
Onychomycosis
Comparative efficacy of Bifonazole cream vs placebo after nail ablation with urea paste
Bayer Identifier:
12999
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Universitätsklinikum Aachen Aachen, Germany, 52074 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. G. Esterle Dresden, Germany, 01277 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. B. Gerlach Dresden, Germany, 01097 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. M. Lübke Berlin, Germany, 10369 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. Hr. Dr. Florian Garbe Berlin, Germany, 13597 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. med. R. Pels Berlin, Germany, 12157 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. H. Prés Berlin, Germany, 10435 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. T. Wildfeuer Berlin, Germany, 13055 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. med. E. Zahn Berlin, Germany, 13187 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dipl. med. Ridwan Weber Augsburg, Germany, 86163 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. med. Marianne Lochno Löbau, Germany, 02708 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Prof. Dr. med. Jürgen Weiß Hannover, Germany, 30159 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. med. Abdou Zarzour Halle, Germany, 06108 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. Martin Kuppinger Potsdam, Germany, 14482 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. PD Dr. T. Dirschka Wuppertal, Germany, 42275 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. T.-M. Ernst Berlin, Germany, 13437 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. K.-G. Meyer Berlin, Germany, 10437 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. P. Uhl Berlin, Germany, 13439 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. Sabine Fischer Leipzig, Germany, 04315 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. M. Simon Berlin, Germany, 10827 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. G. Popp Augsburg, Germany, 86179 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. K. Weis Reichenbach, Germany, 08468 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gemeinschaftspraxis Dr.med. M. Miehe/PD Dr.med. U. Serfling Berlin, Germany, 13507 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. med. Emilia Ponce de Pöschl Oberschleißheim, Germany, 85764 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. med. Adrian Roye Murnau, Germany, 82418 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. med. Wilfried Steinborn Straubing, Germany, 94315 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. Britta Fordran Chemnitz, Germany, 09117 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. med. Andrea Gräfe Northeim, Germany, 37154 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SCIderm GmbH Hamburg, Germany, 20354 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hautzentrum Dülmen Drs. Bockhorst & Dominicus Dülmen, Germany, 48249 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. G. Falker Frankenberg, Germany, 35066 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. E. Thomas Marburg, Germany, 35037 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gabinet Dermatologiczno-Kosmetyczny Bialystok, Poland, 15-660 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gabinet Dermatologiczny dr Joanna Kolinek Pruszkow, Poland, 05-800 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations NZOZ Dermatologia Olsztyn, Poland, 10-501 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Korandova Olomouc, Czech Republic, 77900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Ivona Zikova Louny, Czech Republic, 44001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Jaroslav Dragon Usti nad Labem, Czech Republic, 40010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Sonja Lacinova Chomutov, Czech Republic, 43012 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Poliklinika Dermatologic Department Kutna Hora, Czech Republic, 28401 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dermatologicka ambulance Hlinsko, Czech Republic, 539 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. C. Weidner Gera, Germany, 07551 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxisgemeinschaft Aschoffplatz Freiburg, Germany, 79104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. D.Lichtenthaeler Lübeck, Germany, 23558 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Uniwersyteckie Centrum Kliniczne Gdansk, Poland, 80-952 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Indywidualna Specjalistyczna Praktyka Lekarska Gdansk, Poland, 80-177 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SP Szpital Kliniczny Nr.1 Wroclaw, Poland, 50-369 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kozni ordinace Praha, Czech Republic, 15500 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Sekerova Slany, Czech Republic, 27401 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Trestik Svitavy, Czech Republic, 56802 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dermatologicka ambulance Rychnov nad Kneznou, Czech Republic, 516 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A double-blind, randomized, multicenter, placebo- controlled phase 3 trial to prove the superiority of Bifonazole vs. placebo after 4 weeks of onychomycosis treatment/ as a follow-up of a 2 weeks treatment of non-surgical nail ablation of diseased nail matrix with 40% urea paste
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Overall cure rate comprising clinical cure and mycological cure microscopy + culture negativeTimeframe: 14 days after end of treatment (=visit 3)
Secondary Outcome
- Clinical cure rateTimeframe: 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)
- Culture negativeTimeframe: 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)
- Microscopy negativeTimeframe: 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)
- Relapse rate (overall cure at visit 3 but positive clinical or mycological findings at visit 4Timeframe: 3 and 6 months after end of treatment (=visit 4 and 5)
- Mycological cure rate (microscopy + culture negative)Timeframe: 3 and 6 months after end of treatment (=visit 4 and 5)
- Culture negativeTimeframe: 6 months after end of treatment (=visit 5)
- Incidence of adverse eventsTimeframe: 2 weeks, 3 and 6 months after end of treatment (=visit 3, 4, and 5)
Additional Information
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