Comparative Efficacy of Bifonazole Cream vs Placebo After Nail Ablation With Urea Paste

NCT ID: NCT00781820

Last Updated: 2013-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 693 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-01-31

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.

Conditions

Onychomycosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Arm 2

Group Type: PLACEBO_COMPARATOR

Placebo cream

Intervention Type: DRUG

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

Arm 1

Group Type: EXPERIMENTAL

Bifonazole cream 1%

Intervention Type: DRUG

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

Interventions

Bifonazole cream 1%

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

Intervention Type: DRUG

Placebo cream

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Bayer Consumer Care Inc.

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Chomutov, , Czechia

Hlinsko, , Czechia

Kutná Hora, , Czechia

Louny, , Czechia

Olomouc, , Czechia

Prague, , Czechia

Rychnov nad Kněžnou, , Czechia

Slaný, , Czechia

Svitavy, , Czechia

Ústí nad Labem, , Czechia

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Augsburg, Bavaria, Germany

Augsburg, Bavaria, Germany

Murnau am Staffelsee, Bavaria, Germany

Oberschleißheim, Bavaria, Germany

Straubing, Bavaria, Germany

Potsdam, Brandenburg, Germany

Hamburg, City state of Hamburg, Germany

Frankenberg, Hesse, Germany

Marburg, Hesse, Germany

Hanover, Lower Saxony, Germany

Northeim, Lower Saxony, Germany

Aachen, North Rhine-Westphalia, Germany

Dülmen, North Rhine-Westphalia, Germany

Wuppertal, North Rhine-Westphalia, Germany

Chemnitz, Saxony, Germany

Dresden, Saxony, Germany

Dresden, Saxony, Germany

Leipzig, Saxony, Germany

Löbau, Saxony, Germany

Reichenbach, Saxony, Germany

Halle, Saxony-Anhalt, Germany

Lübeck, Schleswig-Holstein, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Gera, Thuringia, Germany

Bialystok, , Poland

Gdansk, , Poland

Gdansk, , Poland

Olsztyn, , Poland

Pruszków, , Poland

Wroclaw, , Poland

Countries

Czechia; Germany; Poland

Other Identifiers

2008-003215-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12999

Identifier Type: -

Identifier Source: org_study_id