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OpenTrials
Completed

NCT Number: NCT01013909

Comparative Safety and Efficacy Study of New Bifonazol Spray vs Terbinafine Solution vs Placebo

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Berlin, State of Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bifonazole spray once daily

Drug

Application of one dose daily by means of an metered dose

Bifonazole spray twice daily

Drug

Application of two dose daily by means of an metered dose

Placebo

Drug

Application of one dose daily by means of an metered dose

Lamisil Once

Drug

One application of Lamisil Once

Primary outcomes

  1. 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)

  2. Local side effects on the skin

    Time frame: From day 1 through day 42

Secondary outcomes

  1. Clinical cure

    Time frame: After 6 applications (7 and 42 days after start of treatment)

  2. Mycological cure

    Time frame: After 6 applications (7 and 42 days after start of treatment)

  3. Rate of negative culture

    Time frame: After 6 applications (7 and 42 days after start of treatment)

  4. Rate of microscopy negative

    Time frame: After 6 applications (7 and 42 days after start of treatment)

  5. Rate of absence of itching and burning

    Time frame: After 6 applications (7 and 42 days after start of treatment)

  6. Incidence and severity of Adverse Event

    Time frame: From visit 2 (day 3) till visit 7 (day 42)

  7. Vital Signs

    Time frame: Visit 1 (day 1) and visit 7 (day 42)

  8. Local side effects

    Time frame: From visit 2 (day 3) till visit 7 (day 42)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Acronym: Porsche

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 16, 2009
Registry last updated
Jan 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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