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

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.

Study Overview

• Status: Completed
• Conditions: Onychomycosis
• Intervention / Treatment: Drug: Placebo cream; Drug: Bifonazole cream 1%

• Study Type: Interventional
• Enrollment (Actual): 693
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czech Republic
  • Chomutov, Czech Republic, 43012
  • Hlinsko, Czech Republic, 539 01
  • Kutna Hora, Czech Republic, 28401
  • Louny, Czech Republic, 44001
  • Olomouc, Czech Republic, 77900
  • Praha, Czech Republic, 15500
  • Rychnov nad Kneznou, Czech Republic, 516 01
  • Slany, Czech Republic, 27401
  • Svitavy, Czech Republic, 56802
  • Usti nad Labem, Czech Republic, 40010
• Germany
  • Berlin, Germany, 10827
  • Berlin, Germany, 13597
  • Berlin, Germany, 10437
  • Berlin, Germany, 13055
  • Berlin, Germany, 13187
  • Berlin, Germany, 13439
  • Berlin, Germany, 13507
  • Berlin, Germany, 10369
  • Berlin, Germany, 10435
  • Berlin, Germany, 12157
  • Berlin, Germany, 13437
  • Hamburg, Germany, 20354
  • Baden-Württemberg
    • Freiburg, Baden-Württemberg, Germany, 79104
  • Bayern
    • Augsburg, Bayern, Germany, 86163
    • Augsburg, Bayern, Germany, 86179
    • Murnau, Bayern, Germany, 82418
    • Oberschleißheim, Bayern, Germany, 85764
    • Straubing, Bayern, Germany, 94315
  • Brandenburg
    • Potsdam, Brandenburg, Germany, 14482
  • Hessen
    • Frankenberg, Hessen, Germany, 35066
    • Marburg, Hessen, Germany, 35037
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30159
    • Northeim, Niedersachsen, Germany, 37154
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 52074
    • Dülmen, Nordrhein-Westfalen, Germany, 48249
    • Wuppertal, Nordrhein-Westfalen, Germany, 42275
  • Sachsen
    • Chemnitz, Sachsen, Germany, 09117
    • Dresden, Sachsen, Germany, 01277
    • Dresden, Sachsen, Germany, 01097
    • Leipzig, Sachsen, Germany, 04315
    • Löbau, Sachsen, Germany, 02708
    • Reichenbach, Sachsen, Germany, 08468
  • Sachsen-Anhalt
    • Halle, Sachsen-Anhalt, Germany, 06108
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23558
  • Thüringen
    • Gera, Thüringen, Germany, 07551
• Poland
  • Bialystok, Poland, 15-660
  • Gdansk, Poland, 80-952
  • Gdansk, Poland, 80-177
  • Olsztyn, Poland, 10-501
  • Pruszkow, Poland, 05-800
  • Wroclaw, Poland, 50-369

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: 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
Placebo Comparator: Arm 2	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall cure rate comprising clinical cure and mycological cure microscopy + culture negative	14 days after end of treatment (=visit 3)

Secondary Outcome Measures

Outcome Measure	Time Frame
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)
Culture negative	6 months after end of treatment (=visit 5)
Incidence of adverse events	2 weeks, 3 and 6 months after end of treatment (=visit 3, 4, and 5)

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: October 28, 2008
• First Submitted That Met QC Criteria: October 28, 2008
• First Posted (Estimate): October 29, 2008

Study Record Updates

• Last Update Posted (Estimate): June 11, 2013
• Last Update Submitted That Met QC Criteria: June 9, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Placebo; Bifonazole; Urea; Nail fungus
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis; Anti-Infective Agents; Antifungal Agents; Bifonazole
• Other Study ID Numbers: 12999; 2008-003215-13 (EudraCT Number)