NCT01013909

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 16, 2009

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

January 27, 2015

Status Verified

January 1, 2015

Enrollment Period

5 months

First QC Date

October 9, 2009

Last Update Submit

January 26, 2015

Conditions

Tinea Pedis

Keywords

BifonazoleTerbinafineReduced treatment durationEfficacySafetyAthlete's footModerate severity

Outcome Measures

Primary Outcomes (2)

  • 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)

  • Local side effects on the skin

    From day 1 through day 42

Secondary Outcomes (8)

  • Clinical cure

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

  • Mycological cure

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

  • Rate of negative culture

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

  • Rate of microscopy negative

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

  • Rate of absence of itching and burning

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

  • +3 more secondary outcomes

Study Arms (5)

Arm 1

EXPERIMENTAL
Drug: Bifonazole spray once daily

Arm 2

EXPERIMENTAL
Drug: Bifonazole spray twice daily

Arm 3

PLACEBO COMPARATOR
Drug: Placebo

Arm 4

PLACEBO COMPARATOR
Drug: Placebo

Arm 5

ACTIVE COMPARATOR
Drug: Lamisil Once

Interventions

Bifonazole spray once dailyDRUG

Application of one dose daily by means of an metered dose

Arm 1
Bifonazole spray twice dailyDRUG

Application of two dose daily by means of an metered dose

Arm 2
PlaceboDRUG

Application of one dose daily by means of an metered dose

Arm 3
Lamisil OnceDRUG

One application of Lamisil Once

Arm 5

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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'

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Berlin, State of Berlin, 10437, Germany

Location

Unknown Facility

Berlin, State of Berlin, 13055, Germany

Location

Unknown Facility

Berlin, State of Berlin, 13187, Germany

Location

Unknown Facility

Berlin, State of Berlin, 13439, Germany

Location

Related Links

MeSH Terms

Conditions

Tinea Pedis

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousFoot DermatosesFoot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPruritusSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2009

First Posted

November 16, 2009

Study Start

December 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

January 27, 2015

Record last verified: 2015-01

Locations

DE(4)