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

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.

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

Study Overview

• Status: Completed
• Conditions: Tinea Pedis
• Intervention / Treatment: Drug: Bifonazole spray once daily; Drug: Bifonazole spray twice daily; Drug: Placebo; Drug: Lamisil Once

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10437
  • Berlin, Germany, 13055
  • Berlin, Germany, 13187
  • Berlin, Germany, 13439

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here and search for websynopsis provided by the EMA

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: October 9, 2009
• First Submitted That Met QC Criteria: November 13, 2009
• First Posted (Estimate): November 16, 2009

Study Record Updates

• Last Update Posted (Estimate): January 27, 2015
• Last Update Submitted That Met QC Criteria: January 26, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Athlete's foot; Bifonazole; Terbinafine; Reduced treatment duration; Moderate severity
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Tinea; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea Pedis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antifungal Agents; Terbinafine; Bifonazole
• Other Study ID Numbers: 13957; 2008-005654-21 (EudraCT Number)