check_circleStudy Completed

Tinea Pedis

Bayer Identifier:

13957

ClinicalTrials.gov Identifier:

NCT01013909

EudraCT Number:

2008-005654-21

EU CT Number:

Not Available
Comparative safety and efficacy study of new Bifonazol spray vs Terbinafine solution vs placebo

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - 70 Years
  • - 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'
  • - 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

Trial summary

Enrollment Goal
220
Trial Dates
December 2009 - May 2010
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Bifonazole (BAYH4502)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Praxis Hr. Dr. K.-G. MeyerBerlin, 10437, Germany
Completed
Praxis Hr. Dr. T. WildfeuerBerlin, 13055, Germany
Completed
Praxis Hr. Dr. P. UhlBerlin, 13439, Germany
Completed
Praxis Fr. Dr. med. E. ZahnBerlin, 13187, Germany

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 microscopy
    date_rangeTime Frame:
    After 6 applications (7 and 42 days after start of treatment)
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    Safety Issue:
    no
  • Local side effects on the skin
    date_rangeTime Frame:
    From day 1 through day 42
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    Safety Issue:
    yes

Secondary Outcome

  • Clinical cure
    date_rangeTime Frame:
    After 6 applications (7 and 42 days after start of treatment)
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    Safety Issue:
    no
  • Mycological cure
    date_rangeTime Frame:
    After 6 applications (7 and 42 days after start of treatment)
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    Safety Issue:
    No
  • Rate of negative culture
    date_rangeTime Frame:
    After 6 applications (7 and 42 days after start of treatment)
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    Safety Issue:
    no
  • Rate of microscopy negative
    date_rangeTime Frame:
    After 6 applications (7 and 42 days after start of treatment)
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    Safety Issue:
    no
  • Rate of absence of itching and burning
    date_rangeTime Frame:
    After 6 applications (7 and 42 days after start of treatment)
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    Safety Issue:
    no
  • Incidence and severity of Adverse Event
    date_rangeTime Frame:
    From visit 2 (day 3) till visit 7 (day 42)
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    Safety Issue:
    yes
  • Vital Signs
    date_rangeTime Frame:
    Visit 1 (day 1) and visit 7 (day 42)
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    Safety Issue:
    yes
  • Local side effects
    date_rangeTime Frame:
    From visit 2 (day 3) till visit 7 (day 42)
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    Safety Issue:
    yes

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

Additional Information

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