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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01013909
First received: October 9, 2009
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Local side effects on the skin [ Time Frame: From day 1 through day 42 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical cure [ Time Frame: After 6 applications (7 and 42 days after start of treatment) ] [ Designated as safety issue: No ]
  • Mycological cure [ Time Frame: After 6 applications (7 and 42 days after start of treatment) ] [ Designated as safety issue: No ]
  • Rate of negative culture [ Time Frame: After 6 applications (7 and 42 days after start of treatment) ] [ Designated as safety issue: No ]
  • Rate of microscopy negative [ Time Frame: After 6 applications (7 and 42 days after start of treatment) ] [ Designated as safety issue: No ]
  • Rate of absence of itching and burning [ Time Frame: After 6 applications (7 and 42 days after start of treatment) ] [ Designated as safety issue: No ]
  • Incidence and severity of Adverse Event [ Time Frame: From visit 2 (day 3) till visit 7 (day 42) ] [ Designated as safety issue: Yes ]
  • Vital Signs [ Time Frame: Visit 1 (day 1) and visit 7 (day 42) ] [ Designated as safety issue: Yes ]
  • Local side effects [ Time Frame: From visit 2 (day 3) till visit 7 (day 42) ] [ Designated as safety issue: Yes ]

Enrollment: 220
Study Start Date: December 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  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: NCT01013909

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01013909     History of Changes
Other Study ID Numbers: 13957, 2008-005654-21
Study First Received: October 9, 2009
Last Updated: February 27, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on July 20, 2014