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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01013909
Other study ID # 13957
Secondary ID 2008-005654-21
Status Completed
Phase Phase 2
First received October 9, 2009
Last updated January 26, 2015
Start date December 2009
Est. completion date May 2010

Study information

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

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Bifonazole spray once daily
Application of one dose daily by means of an metered dose
Bifonazole spray twice daily
Application of two dose daily by means of an metered dose
Placebo
Application of one dose daily by means of an metered dose
Placebo
Application of one dose daily by means of an metered dose
Lamisil Once
One application of Lamisil Once

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

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
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