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OnychomycosisPhase 3NCT00781820

Comparative Efficacy of Bifonazole Cream vs Placebo After Nail Ablation With Urea Paste

A Phase 3 study testing Bifonazole cream 1% in people with Onychomycosis, run by Bayer at 51 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is focused to prove that the efficacy of a 1% Bifonazole cream is superior to a placebo cream after non-surgical nail ablation with a 40% urea paste. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Onychomycosis
What is being tested?
Bifonazole cream 1%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
693 participants
Where
51 sitesin 3 countries
Study dates
Oct 2008to Jan 2010
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age of at least 18 years;
  • Positive clinical findings of onychomycosis according to the judgement of the investigator (e.g. thickening, discoloration, structural changes, misshaped nails);
  • Positive mycological findings (positive microscopy and positive culture with identification of pathogen) in material taken from affected nail sites before the start of treatment;
  • Nail mycosis with an affected nail area between 20% and 50% in the target nail,
  • Nail mycosis in not more than 3 nails (each nail not more than 50% infected area)

Who cannot join

  • Doubtful or negative mycological findings;
  • Proximal subungual onychomycosis (PSO);
  • Topical antimycotic treatment of feet or hands within 4 weeks prior to screening, topical treatment of onychomycosis of feet or hands within 12 weeks prior to screening;
  • Systemic antimycotic treatment within 12 weeks prior to screening;
  • Failure to treat tinea pedis/manus (diagnosed at screening) successfully with topical treatment between screening visit and visit 1 (baseline);
  • Tinea pedis/manus at visit 1 (baseline);
Show all 13Show fewer
  • Uncontrolled diabetes mellitus
  • Psoriasis
  • Peripheral arterial disease
  • Chronic venous insufficiency;
  • Diabetic neuropathy;
  • History of hypersensitivity to bifonazole, or any other similar pharmacological agents or components of the products;
  • Known sensitivity to plasters.

Trial locations and contacts

51 sites in 3 countries.

51 sites in 3 countries

Germany35 sites

  • Study site

    Aachen, North Rhine-Westphalia, 52074

  • Study site

    Augsburg, Bavaria, 86163

  • Study site

    Augsburg, Bavaria, 86179

  • Study site

    Berlin, State of Berlin, 10369

  • Study site

    Berlin, State of Berlin, 10435

  • Study site

    Berlin, State of Berlin, 10437

  • Study site

    Berlin, State of Berlin, 10827

  • Study site

    Berlin, State of Berlin, 12157

  • Study site

    Berlin, State of Berlin, 13055

  • Study site

    Berlin, State of Berlin, 13187

  • Study site

    Berlin, State of Berlin, 13437

  • Study site

    Berlin, State of Berlin, 13439

  • Study site

    Berlin, State of Berlin, 13507

  • Study site

    Berlin, State of Berlin, 13597

  • Study site

    Chemnitz, Saxony, 09117

  • Study site

    Dresden, Saxony, 01097

  • Study site

    Dresden, Saxony, 01277

  • Study site

    Dülmen, North Rhine-Westphalia, 48249

  • Study site

    Frankenberg, Hesse, 35066

  • Study site

    Freiburg im Breisgau, Baden-Wurttemberg, 79104

  • Study site

    Gera, Thuringia, 07551

  • Study site

    Halle, Saxony-Anhalt, 06108

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 20354

  • Study site

    Hanover, Lower Saxony, 30159

  • Study site

    Leipzig, Saxony, 04315

  • Study site

    Löbau, Saxony, 02708

  • Study site

    Lübeck, Schleswig-Holstein, 23558

  • Study site

    Marburg, Hesse, 35037

  • Study site

    Murnau am Staffelsee, Bavaria, 82418

  • Study site

    Northeim, Lower Saxony, 37154

  • Study site

    Oberschleißheim, Bavaria, 85764

  • Study site

    Potsdam, Brandenburg, 14482

  • Study site

    Reichenbach, Saxony, 08468

  • Study site

    Straubing, Bavaria, 94315

  • Study site

    Wuppertal, North Rhine-Westphalia, 42275

Other trials in Germany

Czechia10 sites

  • Study site

    Chomutov, 43012

  • Study site

    Hlinsko, 539 01

  • Study site

    Kutná Hora, 28401

  • Study site

    Louny, 44001

  • Study site

    Olomouc, 77900

  • Study site

    Prague, 15500

  • Study site

    Rychnov nad Kněžnou, 516 01

  • Study site

    Slaný, 27401

  • Study site

    Svitavy, 56802

  • Study site

    Ústí nad Labem, 40010

Other trials in Czechia

Poland6 sites

  • Study site

    Bialystok, 15-660

  • Study site

    Gdansk, 80-177

  • Study site

    Gdansk, 80-952

  • Study site

    Olsztyn, 10-501

  • Study site

    Pruszków, 05-800

  • Study site

    Wroclaw, 50-369

Other trials in Poland

About this study

Official title: A Double-blind, Randomized, Multicenter, Placebo- Controlled Phase 3 Trial to Prove the Superiority of Bifonazole vs. Placebo After 4 Weeks of Onychomycosis Treatment/ as a Follow-up of a 2 Weeks Treatment of Non-surgical Nail Ablation of Diseased Nail Matrix With 40% Urea Paste

The study is focused to prove that the efficacy of a 1% Bifonazole cream is superior to a placebo cream after non-surgical nail ablation with a 40% urea paste.

Conditions
Onychomycosis
Being tested
Bifonazole cream 1%, Placebo cream
Keywords
Bifonazole, Placebo, Urea, Nail fungus
Medical subject headings
Onychomycosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bifonazole cream 1%Drug

    1 squeeze of Bifonazole cream sufficient to cover the infected nail bed(s) with a thin layer once daily for 28 days after nail ablation with urea paste

  • Placebo creamDrug

    1 squeeze of Placebo cream sufficient to cover the infected nail bed(s) with a thin layer once daily for 28 days after nail ablation with urea paste

Study groups in NCT00781820
Study groupRoleWhat they receive
Arm 2Placebo comparatorNot described
Receives: Drug: Placebo cream
Arm 1ExperimentalNot described
Receives: Drug: Bifonazole cream 1%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall cure rate comprising clinical cure and mycological cure microscopy + culture negative

    Measured: 14 days after end of treatment (=visit 3)

Secondary outcomes (7)

  1. Clinical cure rate

    Measured: 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)

  2. Culture negative

    Measured: 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)

  3. Microscopy negative

    Measured: 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)

  4. Relapse rate (overall cure at visit 3 but positive clinical or mycological findings at visit 4

    Measured: 3 and 6 months after end of treatment (=visit 4 and 5)

  5. Mycological cure rate (microscopy + culture negative)

    Measured: 3 and 6 months after end of treatment (=visit 4 and 5)

  6. Culture negative

    Measured: 6 months after end of treatment (=visit 5)

  7. Incidence of adverse events

    Measured: 2 weeks, 3 and 6 months after end of treatment (=visit 3, 4, and 5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionJan 2010
  4. Study completionJan 2010

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
693 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00781820
Sponsor's protocol ID
12999
Other IDs
2008-003215-13, 2008
Status last verified
Jun 2013
First submitted
28 Oct 2008
Last updated
11 Jun 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bifonazole cream 1% in people with Onychomycosis, run by Bayer at 51 sites in 3 countries.

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 5 inclusion and 13 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 11 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in Germany, Czechia, Poland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Overall cure rate comprising clinical cure and mycological cure microscopy + culture negative (time frame: 14 days after end of treatment (=visit 3)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00781820.

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 11 Jun 2013.

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