Comparative Efficacy of Bifonazole Cream vs Placebo After Nail Ablation With Urea Paste
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
2 other identifiers
interventional
693
3 countries
51
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2008
Shorter than P25 for phase_3
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 28, 2008
CompletedFirst Posted
Study publicly available on registry
October 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedJune 11, 2013
June 1, 2013
1.3 years
October 28, 2008
June 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall cure rate comprising clinical cure and mycological cure microscopy + culture negative
14 days after end of treatment (=visit 3)
Secondary Outcomes (7)
Clinical cure rate
14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)
Culture negative
14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)
Microscopy negative
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 4
3 and 6 months after end of treatment (=visit 4 and 5)
Mycological cure rate (microscopy + culture negative)
3 and 6 months after end of treatment (=visit 4 and 5)
- +2 more secondary outcomes
Study Arms (2)
Arm 2
PLACEBO COMPARATORArm 1
EXPERIMENTALInterventions
1 squeeze of Bifonazole cream sufficient to cover the infected nail bed(s) with a thin layer once daily for 28 days after nail ablation with urea paste
1 squeeze of Placebo cream sufficient to cover the infected nail bed(s) with a thin layer once daily for 28 days after nail ablation with urea paste
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (51)
Unknown Facility
Chomutov, 43012, Czechia
Unknown Facility
Hlinsko, 539 01, Czechia
Unknown Facility
Kutná Hora, 28401, Czechia
Unknown Facility
Louny, 44001, Czechia
Unknown Facility
Olomouc, 77900, Czechia
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Prague, 15500, Czechia
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Rychnov nad Kněžnou, 516 01, Czechia
Unknown Facility
Slaný, 27401, Czechia
Unknown Facility
Svitavy, 56802, Czechia
Unknown Facility
Ústí nad Labem, 40010, Czechia
Unknown Facility
Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany
Unknown Facility
Augsburg, Bavaria, 86163, Germany
Unknown Facility
Augsburg, Bavaria, 86179, Germany
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Murnau am Staffelsee, Bavaria, 82418, Germany
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Oberschleißheim, Bavaria, 85764, Germany
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Straubing, Bavaria, 94315, Germany
Unknown Facility
Potsdam, Brandenburg, 14482, Germany
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Hamburg, Hamburg, 20354, Germany
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Frankenberg, Hesse, 35066, Germany
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Marburg, Hesse, 35037, Germany
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Hanover, Lower Saxony, 30159, Germany
Unknown Facility
Northeim, Lower Saxony, 37154, Germany
Unknown Facility
Aachen, North Rhine-Westphalia, 52074, Germany
Unknown Facility
Dülmen, North Rhine-Westphalia, 48249, Germany
Unknown Facility
Wuppertal, North Rhine-Westphalia, 42275, Germany
Unknown Facility
Chemnitz, Saxony, 09117, Germany
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Dresden, Saxony, 01097, Germany
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Dresden, Saxony, 01277, Germany
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Leipzig, Saxony, 04315, Germany
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Löbau, Saxony, 02708, Germany
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Reichenbach, Saxony, 08468, Germany
Unknown Facility
Halle, Saxony-Anhalt, 06108, Germany
Unknown Facility
Lübeck, Schleswig-Holstein, 23558, Germany
Unknown Facility
Berlin, State of Berlin, 10369, Germany
Unknown Facility
Berlin, State of Berlin, 10435, Germany
Unknown Facility
Berlin, State of Berlin, 10437, Germany
Unknown Facility
Berlin, State of Berlin, 10827, Germany
Unknown Facility
Berlin, State of Berlin, 12157, Germany
Unknown Facility
Berlin, State of Berlin, 13055, Germany
Unknown Facility
Berlin, State of Berlin, 13187, Germany
Unknown Facility
Berlin, State of Berlin, 13437, Germany
Unknown Facility
Berlin, State of Berlin, 13439, Germany
Unknown Facility
Berlin, State of Berlin, 13507, Germany
Unknown Facility
Berlin, State of Berlin, 13597, Germany
Unknown Facility
Gera, Thuringia, 07551, Germany
Unknown Facility
Bialystok, 15-660, Poland
Unknown Facility
Gdansk, 80-177, Poland
Unknown Facility
Gdansk, 80-952, Poland
Unknown Facility
Olsztyn, 10-501, Poland
Unknown Facility
Pruszków, 05-800, Poland
Unknown Facility
Wroclaw, 50-369, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 28, 2008
First Posted
October 29, 2008
Study Start
October 1, 2008
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
June 11, 2013
Record last verified: 2013-06