Tinea PedisPhase 2PorscheNCT01013909
Comparative Safety and Efficacy Study of New Bifonazol Spray vs Terbinafine Solution vs Placebo
A Phase 2 study testing Bifonazole spray once daily, Bifonazole spray twice daily and Lamisil Once in people with Tinea Pedis, run by Bayer at 4 sites in Germany.
Trial summary
The study shall prove whether 6 consecutive doses of Bifonazole spray show comparable efficacy to a Terbinafine solution applied once. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- Bifonazole spray once daily, Bifonazole spray twice daily and Lamisil Once
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 4 sitesGermany
- Study dates
- Dec 2009to May 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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'
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
Germany4 sites
Study site
Berlin, State of Berlin, 10437
Study site
Berlin, State of Berlin, 13055
Study site
Berlin, State of Berlin, 13187
Study site
Berlin, State of Berlin, 13439
About this study
Official 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.
The study shall prove whether 6 consecutive doses of Bifonazole spray show comparable efficacy to a Terbinafine solution applied once.
- Conditions
- Tinea Pedis
- Being tested
- Bifonazole spray once daily, Bifonazole spray twice daily, Placebo, Lamisil Once
- Keywords
- Bifonazole, Terbinafine, Reduced treatment duration, Efficacy, Safety, Athlete's foot, Moderate severity
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifonazole spray once dailyDrug
Application of one dose daily by means of an metered dose
Bifonazole spray twice dailyDrug
Application of two dose daily by means of an metered dose
PlaceboDrug
Application of one dose daily by means of an metered dose
PlaceboDrug
Application of one dose daily by means of an metered dose
Lamisil OnceDrug
One application of Lamisil Once
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Bifonazole spray once daily |
| Arm 2 | Experimental | Not described Receives: Drug: Bifonazole spray twice daily |
| Arm 3 | Placebo comparator | Not described Receives: Drug: Placebo |
| Arm 4 | Placebo comparator | Not described Receives: Drug: Placebo |
| Arm 5 | Active comparator | Not described Receives: Drug: Lamisil Once |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After 6 applications (7 and 42 days after start of treatment)
Local side effects on the skin
Measured: From day 1 through day 42
Secondary outcomes (8)
Clinical cure
Measured: After 6 applications (7 and 42 days after start of treatment)
Mycological cure
Measured: After 6 applications (7 and 42 days after start of treatment)
Rate of negative culture
Measured: After 6 applications (7 and 42 days after start of treatment)
Rate of microscopy negative
Measured: After 6 applications (7 and 42 days after start of treatment)
Rate of absence of itching and burning
Measured: After 6 applications (7 and 42 days after start of treatment)
Incidence and severity of Adverse Event
Measured: From visit 2 (day 3) till visit 7 (day 42)
Vital Signs
Measured: Visit 1 (day 1) and visit 7 (day 42)
Local side effects
Measured: From visit 2 (day 3) till visit 7 (day 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea PedisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013909
- Sponsor's protocol ID
- 13957
- Other IDs
- 2008-005654-21, 2008
- Acronym
- Porsche
- Status last verified
- Jan 2015
- First submitted
- 9 Oct 2009
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT01013909
- Acronym / sponsor ID
- Porsche / 13957
- Conditions
- Tinea Pedis
- Keywords
- Bifonazole, Terbinafine, Reduced treatment duration, Efficacy, Safety, Athlete's foot, Moderate severity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 16 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study shall prove whether 6 consecutive doses of Bifonazole spray show comparable efficacy to a Terbinafine solution applied once.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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'
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifonazole spray once dailyApplication of one dose daily by means of an metered dose | Drug | Arm 1 |
| Bifonazole spray twice dailyApplication of two dose daily by means of an metered dose | Drug | Arm 2 |
| PlaceboApplication of one dose daily by means of an metered dose | Drug | Arm 3 |
| PlaceboApplication of one dose daily by means of an metered dose | Drug | Arm 4 |
| Lamisil OnceOne application of Lamisil Once | Drug | Arm 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 microscopy
Time frame: After 6 applications (7 and 42 days after start of treatment)
Local side effects on the skin
Time frame: From day 1 through day 42
8 secondary outcomes
Clinical cure
Time frame: After 6 applications (7 and 42 days after start of treatment)
Mycological cure
Time frame: After 6 applications (7 and 42 days after start of treatment)
Rate of negative culture
Time frame: After 6 applications (7 and 42 days after start of treatment)
Rate of microscopy negative
Time frame: After 6 applications (7 and 42 days after start of treatment)
Rate of absence of itching and burning
Time frame: After 6 applications (7 and 42 days after start of treatment)
Incidence and severity of Adverse Event
Time frame: From visit 2 (day 3) till visit 7 (day 42)
Vital Signs
Time frame: Visit 1 (day 1) and visit 7 (day 42)
Local side effects
Time frame: From visit 2 (day 3) till visit 7 (day 42)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
- Click here and search for websynopsis provided by the EMALink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bifonazole spray once daily, Bifonazole spray twice daily and Lamisil Once in people with Tinea Pedis, run by Bayer at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2015.