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

Phase 3

Completed

• Conditions: Onychomycosis
• Interventions: Drug: Placebo cream; Drug: Bifonazole cream 1%

• Registration Number: NCT00781820
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-28
• Study First Submitted QC: 2008-10-28
• Study First Posted: 2008-10-29
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-09
• Last Update Posted: 2013-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 693

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Placebo cream	-
Arm 1	Bifonazole cream 1%	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Clinical cure rate	14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)
Culture negative	6 months after end of treatment (=visit 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)
Incidence of adverse events	2 weeks, 3 and 6 months after end of treatment (=visit 3, 4, and 5)