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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00781820

Enrollment

693

Registered

2008-10-29

Start date

2008-10-31

Completion date

2010-01-31

Last updated

2013-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Onychomycosis

Keywords

Bifonazole, Placebo, Urea, Nail fungus

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.

Interventions

DRUGBifonazole 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

DRUGPlacebo 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Overall cure rate comprising clinical cure and mycological cure microscopy + culture negative	14 days after end of treatment (=visit 3)

Secondary

Measure	Time frame
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)
Clinical cure rate	14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)
Mycological cure rate (microscopy + culture negative)	3 and 6 months after end of treatment (=visit 4 and 5)
Incidence of adverse events	2 weeks, 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)

Countries

Czechia, Germany, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026