Comparative Safety and Efficacy Study of New Bifonazol Spray vs Terbinafine Solution vs Placebo (Porsche)
Primary Purpose
Tinea Pedis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Bifonazole spray once daily
Bifonazole spray twice daily
Placebo
Placebo
Lamisil Once
Sponsored by
About this trial
This is an interventional treatment trial for Tinea Pedis focused on measuring Bifonazole, Terbinafine, Reduced treatment duration, Efficacy, Safety, Athlete's foot, Moderate severity
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Active Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Description
Outcomes
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
Local side effects on the skin
Secondary Outcome Measures
Clinical cure
Mycological cure
Rate of negative culture
Rate of microscopy negative
Rate of absence of itching and burning
Incidence and severity of Adverse Event
Vital Signs
Local side effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01013909
Brief Title
Comparative Safety and Efficacy Study of New Bifonazol Spray vs Terbinafine Solution vs Placebo
Acronym
Porsche
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 Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study shall prove whether 6 consecutive doses of Bifonazole spray show comparable efficacy to a Terbinafine solution applied once.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Pedis
Keywords
Bifonazole, Terbinafine, Reduced treatment duration, Efficacy, Safety, Athlete's foot, Moderate severity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Placebo Comparator
Arm Title
Arm 4
Arm Type
Placebo Comparator
Arm Title
Arm 5
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bifonazole spray once daily
Intervention Description
Application of one dose daily by means of an metered dose
Intervention Type
Drug
Intervention Name(s)
Bifonazole spray twice daily
Intervention Description
Application of two dose daily by means of an metered dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Application of one dose daily by means of an metered dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Application of one dose daily by means of an metered dose
Intervention Type
Drug
Intervention Name(s)
Lamisil Once
Intervention Description
One application of Lamisil Once
Primary Outcome Measure Information:
Title
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)
Title
Local side effects on the skin
Time Frame
From day 1 through day 42
Secondary Outcome Measure Information:
Title
Clinical cure
Time Frame
After 6 applications (7 and 42 days after start of treatment)
Title
Mycological cure
Time Frame
After 6 applications (7 and 42 days after start of treatment)
Title
Rate of negative culture
Time Frame
After 6 applications (7 and 42 days after start of treatment)
Title
Rate of microscopy negative
Time Frame
After 6 applications (7 and 42 days after start of treatment)
Title
Rate of absence of itching and burning
Time Frame
After 6 applications (7 and 42 days after start of treatment)
Title
Incidence and severity of Adverse Event
Time Frame
From visit 2 (day 3) till visit 7 (day 42)
Title
Vital Signs
Time Frame
Visit 1 (day 1) and visit 7 (day 42)
Title
Local side effects
Time Frame
From visit 2 (day 3) till visit 7 (day 42)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Berlin
ZIP/Postal Code
10437
Country
Germany
City
Berlin
ZIP/Postal Code
13055
Country
Germany
City
Berlin
ZIP/Postal Code
13187
Country
Germany
City
Berlin
ZIP/Postal Code
13439
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrialsregister.eu
Description
Click here and search for websynopsis provided by the EMA
Learn more about this trial
Comparative Safety and Efficacy Study of New Bifonazol Spray vs Terbinafine Solution vs Placebo
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