Clinical trial NCT01013909: Comparative Safety and Efficacy Study of New Bifonazol Spray vs Terbinafine Solution vs Placebo
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tinea Pedis
Keywords: Bifonazole
Terbinafine
Reduced treatment duration
Efficacy
Safety
Athlete's foot
Moderate severity
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-11-16
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: After 6 applications (7 and 42 days after start of treatment)
measure: Local side effects on the skin
timeFrame: From day 1 through day 42
Secondary outcomes:
measure: Clinical cure
timeFrame: After 6 applications (7 and 42 days after start of treatment)
measure: Mycological cure
timeFrame: After 6 applications (7 and 42 days after start of treatment)
measure: Rate of negative culture
timeFrame: After 6 applications (7 and 42 days after start of treatment)
measure: Rate of microscopy negative
timeFrame: After 6 applications (7 and 42 days after start of treatment)
measure: Rate of absence of itching and burning
timeFrame: After 6 applications (7 and 42 days after start of treatment)
measure: Incidence and severity of Adverse Event
timeFrame: From visit 2 (day 3) till visit 7 (day 42)
measure: Vital Signs
timeFrame: Visit 1 (day 1) and visit 7 (day 42)
measure: Local side effects
timeFrame: From visit 2 (day 3) till visit 7 (day 42)
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: