Trial Condition(s):
Tinea Pedis
Comparative safety and efficacy study of new Bifonazol spray vs Terbinafine solution vs placebo (Porsche)
Bayer Identifier:
13957
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The study shall prove whether 6 consecutive doses of Bifonazole spray show comparable efficacy to a Terbinafine solution applied once.
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 screeningTrial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Praxis Hr. Dr. K.-G. Meyer Berlin, Germany, 10437 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. T. Wildfeuer Berlin, Germany, 13055 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. P. Uhl Berlin, Germany, 13439 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. med. E. Zahn Berlin, Germany, 13187 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Single Blind
Assignment:
Parallel Assignment
Trial Arms:
5
Primary Outcome
- 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 microscopyTimeframe: After 6 applications (7 and 42 days after start of treatment)
- Local side effects on the skinTimeframe: From day 1 through day 42
Secondary Outcome
- Clinical cureTimeframe: After 6 applications (7 and 42 days after start of treatment)
- Mycological cureTimeframe: After 6 applications (7 and 42 days after start of treatment)
- Rate of negative cultureTimeframe: After 6 applications (7 and 42 days after start of treatment)
- Rate of microscopy negativeTimeframe: After 6 applications (7 and 42 days after start of treatment)
- Rate of absence of itching and burningTimeframe: After 6 applications (7 and 42 days after start of treatment)
- Incidence and severity of Adverse EventTimeframe: From visit 2 (day 3) till visit 7 (day 42)
- Vital SignsTimeframe: Visit 1 (day 1) and visit 7 (day 42)
- Local side effectsTimeframe: From visit 2 (day 3) till visit 7 (day 42)
Additional Information
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