Clinical trial NCT00781820: Comparative Efficacy of Bifonazole Cream vs Placebo After Nail Ablation With Urea Paste
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Onychomycosis
Keywords: Bifonazole
Placebo
Urea
Nail fungus
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-10-29
Enrollment: 693
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Overall cure rate comprising clinical cure and mycological cure microscopy + culture negative
timeFrame: 14 days after end of treatment (=visit 3)
Secondary outcomes:
measure: Clinical cure rate
timeFrame: 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)
measure: Culture negative
timeFrame: 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)
measure: Microscopy negative
timeFrame: 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)
measure: Relapse rate (overall cure at visit 3 but positive clinical or mycological findings at visit 4
timeFrame: 3 and 6 months after end of treatment (=visit 4 and 5)
measure: Mycological cure rate (microscopy + culture negative)
timeFrame: 3 and 6 months after end of treatment (=visit 4 and 5)
measure: Culture negative
timeFrame: 6 months after end of treatment (=visit 5)
measure: Incidence of adverse events
timeFrame: 2 weeks, 3 and 6 months after end of treatment (=visit 3, 4, and 5)
Other outcomes:
Locations:
city: Chomutov
country: Czech Republic
city: Hlinsko
country: Czech Republic
city: Kutna Hora
country: Czech Republic
city: Louny
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Praha
country: Czech Republic
city: Rychnov nad Kneznou
country: Czech Republic
city: Slany
country: Czech Republic
city: Svitavy
country: Czech Republic
city: Usti nad Labem
country: Czech Republic
city: Freiburg
country: Germany
state: Baden-Württemberg
city: Augsburg
country: Germany
state: Bayern
city: Augsburg
country: Germany
state: Bayern
city: Murnau
country: Germany
state: Bayern
city: Oberschleißheim
country: Germany
state: Bayern
city: Straubing
country: Germany
state: Bayern
city: Potsdam
country: Germany
state: Brandenburg
city: Frankenberg
country: Germany
state: Hessen
city: Marburg
country: Germany
state: Hessen
city: Hannover
country: Germany
state: Niedersachsen
city: Northeim
country: Germany
state: Niedersachsen
city: Aachen
country: Germany
state: Nordrhein-Westfalen
city: Dülmen
country: Germany
state: Nordrhein-Westfalen
city: Wuppertal
country: Germany
state: Nordrhein-Westfalen
city: Halle
country: Germany
state: Sachsen-Anhalt
city: Chemnitz
country: Germany
state: Sachsen
city: Dresden
country: Germany
state: Sachsen
city: Dresden
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Löbau
country: Germany
state: Sachsen
city: Reichenbach
country: Germany
state: Sachsen
city: Lübeck
country: Germany
state: Schleswig-Holstein
city: Gera
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Bialystok
country: Poland
city: Gdansk
country: Poland
city: Gdansk
country: Poland
city: Olsztyn
country: Poland
city: Pruszkow
country: Poland
city: Wroclaw
country: Poland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: