Tinea Pedis Clinical Trial
— PorscheOfficial 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.
| Verified date | January 2015 |
| Source | Bayer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Interventional |
The study shall prove whether 6 consecutive doses of Bifonazole spray show comparable efficacy to a Terbinafine solution applied once.
| Status | Completed |
| Enrollment | 220 |
| Est. completion date | May 2010 |
| Est. primary completion date | May 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Bayer |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No | |
| Primary | Local side effects on the skin | From day 1 through day 42 | Yes | |
| Secondary | Clinical cure | After 6 applications (7 and 42 days after start of treatment) | No | |
| Secondary | Mycological cure | After 6 applications (7 and 42 days after start of treatment) | No | |
| Secondary | Rate of negative culture | After 6 applications (7 and 42 days after start of treatment) | No | |
| Secondary | Rate of microscopy negative | After 6 applications (7 and 42 days after start of treatment) | No | |
| Secondary | Rate of absence of itching and burning | After 6 applications (7 and 42 days after start of treatment) | No | |
| Secondary | Incidence and severity of Adverse Event | From visit 2 (day 3) till visit 7 (day 42) | Yes | |
| Secondary | Vital Signs | Visit 1 (day 1) and visit 7 (day 42) | Yes | |
| Secondary | Local side effects | From visit 2 (day 3) till visit 7 (day 42) | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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