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

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ClinicalTrials.gov Identifier: NCT00781820
Recruitment Status : Completed
First Posted : October 29, 2008
Last Update Posted : June 11, 2013
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Onychomycosis Drug: Bifonazole cream 1% Drug: Placebo cream Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 693 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : October 2008
Primary Completion Date : January 2010
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Overall cure rate comprising clinical cure and mycological cure microscopy + culture negative [ Time Frame: 14 days after end of treatment (=visit 3) ]

Secondary Outcome Measures :
  1. Clinical cure rate [ Time Frame: 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5) ]
  2. Culture negative [ Time Frame: 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5) ]
  3. Microscopy negative [ Time Frame: 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5) ]
  4. 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) ]
  5. Mycological cure rate (microscopy + culture negative) [ Time Frame: 3 and 6 months after end of treatment (=visit 4 and 5) ]
  6. Culture negative [ Time Frame: 6 months after end of treatment (=visit 5) ]
  7. Incidence of adverse events [ Time Frame: 2 weeks, 3 and 6 months after end of treatment (=visit 3, 4, and 5) ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781820


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

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer Consumer Care Inc.
ClinicalTrials.gov Identifier: NCT00781820     History of Changes
Other Study ID Numbers: 12999
2008-003215-13 ( EudraCT Number )
First Posted: October 29, 2008    Key Record Dates
Last Update Posted: June 11, 2013
Last Verified: June 2013

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