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

Bayer

Status and phase

Completed

Phase 3

Conditions

Onychomycosis

Treatments

Drug: Placebo cream

Drug: Bifonazole cream 1%

Study type

Interventional

Funder types

Industry

Identifiers

NCT00781820

12999

2008-003215-13 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

693 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.