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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-05-31

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.

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Detailed Description

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Conditions

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Tinea Pedis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Bifonazole spray once daily

Intervention Type DRUG

Application of one dose daily by means of an metered dose

Arm 2

Group Type EXPERIMENTAL

Bifonazole spray twice daily

Intervention Type DRUG

Application of two dose daily by means of an metered dose

Arm 3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Application of one dose daily by means of an metered dose

Arm 4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Application of one dose daily by means of an metered dose

Arm 5

Group Type ACTIVE_COMPARATOR

Lamisil Once

Intervention Type DRUG

One application of Lamisil Once

Interventions

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Bifonazole spray once daily

Application of one dose daily by means of an metered dose

Intervention Type DRUG

Bifonazole spray twice daily

Application of two dose daily by means of an metered dose

Intervention Type DRUG

Placebo

Application of one dose daily by means of an metered dose

Intervention Type DRUG

Placebo

Application of one dose daily by means of an metered dose

Intervention Type DRUG

Lamisil Once

One application of Lamisil Once

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No