Status:
COMPLETED
Comparative Efficacy of Bifonazole Cream vs Placebo After Nail Ablation With Urea Paste
Lead Sponsor:
Bayer
Conditions:
Onychomycosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
693 Patients enrolled
Trial Details
Trial ID
NCT00781820
Start Date
October 1 2008
End Date
January 1 2010
Last Update
June 11 2013
Active Locations (51)
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1
Chomutov, Czechia, 43012
2
Hlinsko, Czechia, 539 01
3
Kutná Hora, Czechia, 28401
4
Louny, Czechia, 44001