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

Phase 2

Completed

• Conditions: Tinea Pedis
• Interventions: Drug: Placebo; Drug: Lamisil Once; Drug: Bifonazole spray once daily; Drug: Bifonazole spray twice daily

• Registration Number: NCT01013909
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-10-09
• Study First Submitted QC: 2009-11-13
• Study First Posted: 2009-11-16
• Study Start: 2009-12
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-26
• Last Update Posted: 2015-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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'

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 4	Placebo	-
Arm 5	Lamisil Once	-
Arm 1	Bifonazole spray once daily	-
Arm 2	Bifonazole spray twice daily	-
Arm 3	Placebo	-

Primary Outcome Measures

Name	Time	Method
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	After 6 applications (7 and 42 days after start of treatment)
Local side effects on the skin	From day 1 through day 42

Secondary Outcome Measures

Name	Time	Method
Clinical cure	After 6 applications (7 and 42 days after start of treatment)
Mycological cure	After 6 applications (7 and 42 days after start of treatment)
Rate of negative culture	After 6 applications (7 and 42 days after start of treatment)
Rate of microscopy negative	After 6 applications (7 and 42 days after start of treatment)
Incidence and severity of Adverse Event	From visit 2 (day 3) till visit 7 (day 42)
Vital Signs	Visit 1 (day 1) and visit 7 (day 42)
Rate of absence of itching and burning	After 6 applications (7 and 42 days after start of treatment)
Local side effects	From visit 2 (day 3) till visit 7 (day 42)