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

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

Official Title
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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.

Conditions
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Tinea Pedis

Intervention / Treatment
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* Drug: Bifonazole spray once daily
* Drug: Bifonazole spray twice daily
* Drug: Placebo
* Drug: Placebo
* Drug: Lamisil Once


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Bifonazole spray once daily<br>* Application of one dose daily by means of an metered dose<br>|
| Experimental: Arm 2<br> | Drug: Bifonazole spray twice daily<br>* Application of two dose daily by means of an metered dose<br>|
| Placebo Comparator: Arm 3<br> | Drug: Placebo<br>* Application of one dose daily by means of an metered dose<br>|
| Placebo Comparator: Arm 4<br> | Drug: Placebo<br>* Application of one dose daily by means of an metered dose<br>|
| Active Comparator: Arm 5<br> | Drug: Lamisil Once<br>* One application of Lamisil Once<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Rate of absence of itching and burning |  | 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) | 
| Local side effects |  | From visit 2 (day 3) till visit 7 (day 42) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bifonazole, Terbinafine, Reduced treatment duration, Efficacy, Safety, Athlete's foot, Moderate severity