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Comparative Safety and Efficacy Study of New Bifonazol Spray vs Terbinafine Solution vs Placebo (Porsche)

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ClinicalTrials.gov Identifier: NCT01013909
Recruitment Status : Completed
First Posted : November 16, 2009
Last Update Posted : January 27, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
The study shall prove whether 6 consecutive doses of Bifonazole spray show comparable efficacy to a Terbinafine solution applied once.

Condition or disease Intervention/treatment Phase
Tinea Pedis Drug: Bifonazole spray once daily Drug: Bifonazole spray twice daily Drug: Placebo Drug: Lamisil Once Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: An Investigator-blind, Randomized, Multicenter, 5-arm, Placebo- and Active Controlled Parallel Group Pilot Trial to Explore the Efficacy and Tolerability of Topical Bifonazole Liquid Spray in Patients With Athlete's Foot.
Study Start Date : December 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Terbinafine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 Drug: Bifonazole spray once daily
Application of one dose daily by means of an metered dose
Experimental: Arm 2 Drug: Bifonazole spray twice daily
Application of two dose daily by means of an metered dose
Placebo Comparator: Arm 3 Drug: Placebo
Application of one dose daily by means of an metered dose
Placebo Comparator: Arm 4 Drug: Placebo
Application of one dose daily by means of an metered dose
Active Comparator: Arm 5 Drug: Lamisil Once
One application of Lamisil Once



Primary Outcome Measures :
  1. Assessment of erythema, scaling, vesiculation maceration, and pruritus based on a categorial scale (0=absent to 3 =severe), assessment of mycological cure based on cultures and microscopy [ Time Frame: After 6 applications (7 and 42 days after start of treatment) ]
  2. Local side effects on the skin [ Time Frame: From day 1 through day 42 ]

Secondary Outcome Measures :
  1. Clinical cure [ Time Frame: After 6 applications (7 and 42 days after start of treatment) ]
  2. Mycological cure [ Time Frame: After 6 applications (7 and 42 days after start of treatment) ]
  3. Rate of negative culture [ Time Frame: After 6 applications (7 and 42 days after start of treatment) ]
  4. Rate of microscopy negative [ Time Frame: After 6 applications (7 and 42 days after start of treatment) ]
  5. Rate of absence of itching and burning [ Time Frame: After 6 applications (7 and 42 days after start of treatment) ]
  6. Incidence and severity of Adverse Event [ Time Frame: From visit 2 (day 3) till visit 7 (day 42) ]
  7. Vital Signs [ Time Frame: Visit 1 (day 1) and visit 7 (day 42) ]
  8. Local side effects [ Time Frame: From visit 2 (day 3) till visit 7 (day 42) ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects aged between 18 and 70 years
  • Positive clinical findings of athlete's foot, limited to interdigital spaces, with a total athlete's foot severity score (AFSS) of at least 5 and not exceeding 10 points for the signs and symptoms of athlete's foot, and no sign or symptom scoring 'severe'

Exclusion Criteria:

  • Clinical history suggestive of intolerance or allergies to one of the products or the ingredients of the products
  • Plantar tinea pedis ("Mocassin-type")
  • Onychomycosis of any toe
  • Previous treatment with a systemic antifungal within 6 months prior to screening
  • Previous treatment of feet with a topical antifungal within 4 weeks prior to screening
  • Previous treatment with a topical antifungal applied to other areas of the body than feet within 2 weeks prior to screening
  • Previous treatment of any topical medication applied to the feet within 2 weeks prior to screening

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): NCT01013909


Locations
Germany
Berlin, Germany, 10437
Berlin, Germany, 13055
Berlin, Germany, 13187
Berlin, Germany, 13439
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01013909     History of Changes
Other Study ID Numbers: 13957
2008-005654-21 ( EudraCT Number )
First Posted: November 16, 2009    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: January 2015

Keywords provided by Bayer:
Bifonazole
Terbinafine
Reduced treatment duration
Efficacy
Safety
Athlete's foot
Moderate severity

Additional relevant MeSH terms:
Tinea Pedis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Foot Dermatoses
Foot Diseases
Skin Diseases
Pruritus
Skin Manifestations
Signs and Symptoms
Terbinafine
Bifonazole
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action