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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Onychomycosis

Intervention / Treatment
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* Drug: Bifonazole cream 1%
* Drug: Placebo cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm 2<br> | Drug: Placebo cream<br>* 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<br>|
| Experimental: Arm 1<br> | Drug: Bifonazole cream 1%<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bifonazole, Placebo, Urea, Nail fungus