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

Bayer

Status and phase: Completed; Phase 2

Conditions: Tinea Pedis

Treatments: Drug: Lamisil Once; Drug: Bifonazole spray once daily; Drug: Bifonazole spray twice daily; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01013909

13957

2008-005654-21 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 220 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 5 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Bifonazole spray once daily

Arm 2

Experimental group

Treatment:

Drug: Bifonazole spray twice daily

Arm 3

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Arm 4

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Arm 5

Active Comparator group

Treatment:

Drug: Lamisil Once