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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781820
• Other study ID #: 12999
• Secondary ID: 2008-003215-13
• Status: Completed
• Phase: Phase 3
• First received: October 28, 2008
• Last updated: June 9, 2013
• Start date: October 2008
• Est. completion date: January 2010

Study information

• Verified date: June 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesCzech Republic: State Institute for Drug ControlPoland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• Bifonazole cream 1%
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
• Placebo cream
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Czech Republic,  Germany,  Poland, 

Outcome

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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