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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00781820
First received: October 28, 2008
Last updated: June 9, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Onychomycosis
Drug: Bifonazole cream 1%
Drug: Placebo cream
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Overall cure rate comprising clinical cure and mycological cure microscopy + culture negative [ Time Frame: 14 days after end of treatment (=visit 3) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical cure rate [ Time Frame: 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5) ] [ Designated as safety issue: No ]
  • Culture negative [ Time Frame: 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5) ] [ Designated as safety issue: No ]
  • Microscopy negative [ Time Frame: 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5) ] [ Designated as safety issue: No ]
  • Relapse rate (overall cure at visit 3 but positive clinical or mycological findings at visit 4 [ Time Frame: 3 and 6 months after end of treatment (=visit 4 and 5) ] [ Designated as safety issue: No ]
  • Mycological cure rate (microscopy + culture negative) [ Time Frame: 3 and 6 months after end of treatment (=visit 4 and 5) ] [ Designated as safety issue: No ]
  • Culture negative [ Time Frame: 6 months after end of treatment (=visit 5) ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 2 weeks, 3 and 6 months after end of treatment (=visit 3, 4, and 5) ] [ Designated as safety issue: Yes ]

Enrollment: 693
Study Start Date: October 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 2 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
Experimental: Arm 1 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781820

  Show 51 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Consumer Care Inc.
ClinicalTrials.gov Identifier: NCT00781820     History of Changes
Other Study ID Numbers: 12999, 2008-003215-13
Study First Received: October 28, 2008
Last Updated: June 9, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: State Institute for Drug Control
Poland: Ministry of Health

Keywords provided by Bayer:
Bifonazole
Placebo
Urea
Nail fungus

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Bifonazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014