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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


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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