Tinea Pedis
Conditions
Keywords
Bifonazole, Terbinafine, Reduced treatment duration, Efficacy, Safety, Athlete's foot, Moderate severity
Brief summary
The study shall prove whether 6 consecutive doses of Bifonazole spray show comparable efficacy to a Terbinafine solution applied once.
Interventions
DRUGBifonazole spray once daily
Application of one dose daily by means of an metered dose
DRUGBifonazole spray twice daily
Application of two dose daily by means of an metered dose
DRUGPlacebo
Application of one dose daily by means of an metered dose
DRUGLamisil Once
One application of Lamisil Once
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| 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) |
Countries
Germany
Outcome results
None listed