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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Dermatomycoses
Infection
Mycoses
Nail Diseases
Skin Diseases
Skin Diseases, Infectious
Tinea
Bifonazole
Anti-Infective Agents
Antifungal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014