The study shall prove whether 6 consecutive doses of Bifonazole spray show comparable efficacy to a Terbinafine solution applied once.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
220
Application of one dose daily by means of an metered dose
Application of two dose daily by means of an metered dose
Application of one dose daily by means of an metered dose
Unnamed facility
Berlin, State of Berlin, Germany
Unnamed facility
Berlin, State of Berlin, Germany
Unnamed facility
Berlin, State of Berlin, Germany
Unnamed facility
Berlin, State of Berlin, Germany
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
Time frame: After 6 applications (7 and 42 days after start of treatment)
Local side effects on the skin
Time frame: From day 1 through day 42
Clinical cure
Time frame: After 6 applications (7 and 42 days after start of treatment)
Mycological cure
Time frame: After 6 applications (7 and 42 days after start of treatment)
Rate of negative culture
Time frame: After 6 applications (7 and 42 days after start of treatment)
Rate of microscopy negative
Time frame: After 6 applications (7 and 42 days after start of treatment)
Rate of absence of itching and burning
Time frame: After 6 applications (7 and 42 days after start of treatment)
Incidence and severity of Adverse Event
Time frame: From visit 2 (day 3) till visit 7 (day 42)
Vital Signs
Time frame: Visit 1 (day 1) and visit 7 (day 42)
Local side effects
Time frame: From visit 2 (day 3) till visit 7 (day 42)
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Application of one dose daily by means of an metered dose
One application of Lamisil Once