Onychomycosis Clinical Trial
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
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.
Status | Completed |
Enrollment | 693 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Czech Republic, Germany, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall cure rate comprising clinical cure and mycological cure microscopy + culture negative | 14 days after end of treatment (=visit 3) | No | |
Secondary | Clinical cure rate | 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5) | No | |
Secondary | Culture negative | 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5) | No | |
Secondary | Microscopy negative | 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5) | No | |
Secondary | 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) | No | |
Secondary | Mycological cure rate (microscopy + culture negative) | 3 and 6 months after end of treatment (=visit 4 and 5) | No | |
Secondary | Culture negative | 6 months after end of treatment (=visit 5) | No | |
Secondary | Incidence of adverse events | 2 weeks, 3 and 6 months after end of treatment (=visit 3, 4, and 5) | Yes |
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