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

NCT00781820 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 693

Last updated 2013-06-11

No results posted yet for this study

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.

Conditions

  • Onychomycosis

Interventions

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

DRUG

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Czechia
  • Germany
  • Poland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00781820 on ClinicalTrials.gov