check_circleStudy Completed

Onychomycosis

Bayer Identifier:

12999

ClinicalTrials.gov Identifier:

NCT00781820

EudraCT Number:

2008-003215-13

EU CT Number:

Not Available
Comparative efficacy of Bifonazole cream vs placebo after nail ablation with urea paste

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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)
  • - 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);
    - 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 summary

Enrollment Goal
693
Trial Dates
October 2008 - January 2010
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Mycospor/Canesten Extra (Bifonazole, BAYH4502)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Universitätsklinikum AachenAachen, 52074, Germany
Completed
Praxis Hr. Dr. G. EsterleDresden, 01277, Germany
Completed
Praxis Fr. Dr. B. GerlachDresden, 01097, Germany
Completed
Praxis Fr. Dr. M. LübkeBerlin, 10369, Germany
Completed
Praxis Dr. Hr. Dr. Florian GarbeBerlin, 13597, Germany
Completed
Praxis Fr. Dr. med. R. PelsBerlin, 12157, Germany
Completed
Praxis Hr. Dr. H. PrésBerlin, 10435, Germany
Completed
Praxis Hr. Dr. T. WildfeuerBerlin, 13055, Germany
Completed
Praxis Fr. Dr. med. E. ZahnBerlin, 13187, Germany
Completed
Praxis Hr. Dipl. med. Ridwan WeberAugsburg, 86163, Germany
Completed
Praxis Fr. Dr. med. Marianne LochnoLöbau, 02708, Germany
Completed
Praxis Hr. Prof. Dr. med. Jürgen WeißHannover, 30159, Germany
Completed
Praxis Hr. Dr. med. Abdou ZarzourHalle, 06108, Germany
Completed
Praxis Hr. Dr. Martin KuppingerPotsdam, 14482, Germany
Completed
Praxis Hr. PD Dr. T. DirschkaWuppertal, 42275, Germany
Completed
Praxis Hr. Dr. T.-M. ErnstBerlin, 13437, Germany
Completed
Praxis Hr. Dr. K.-G. MeyerBerlin, 10437, Germany
Completed
Praxis Hr. Dr. P. UhlBerlin, 13439, Germany
Completed
Praxis Fr. Dr. Sabine FischerLeipzig, 04315, Germany
Completed
Praxis Fr. Dr. M. SimonBerlin, 10827, Germany
Completed
Praxis Hr. Dr. G. PoppAugsburg, 86179, Germany
Completed
Praxis Fr. Dr. K. WeisReichenbach, 08468, Germany
Completed
Gemeinschaftspraxis Dr.med. M. Miehe/PD Dr.med. U. SerflingBerlin, 13507, Germany
Completed
Praxis Fr. Dr. med. Emilia Ponce de PöschlOberschleißheim, 85764, Germany
Completed
Praxis Hr. Dr. med. Adrian RoyeMurnau, 82418, Germany
Completed
Praxis Hr. Dr. med. Wilfried SteinbornStraubing, 94315, Germany
Completed
Praxis Fr. Dr. Britta FordranChemnitz, 09117, Germany
Completed
Praxis Fr. Dr. med. Andrea GräfeNortheim, 37154, Germany
Completed
SCIderm GmbHHamburg, 20354, Germany
Completed
Hautzentrum Dülmen Drs. Bockhorst & DominicusDülmen, 48249, Germany
Completed
Praxis Hr. Dr. G. FalkerFrankenberg, 35066, Germany
Completed
Praxis Fr. Dr. E. ThomasMarburg, 35037, Germany
Completed
Gabinet Dermatologiczno-KosmetycznyBialystok, 15-660, Poland
Completed
Gabinet Dermatologiczny dr Joanna KolinekPruszkow, 05-800, Poland
Completed
NZOZ DermatologiaOlsztyn, 10-501, Poland
Completed
Dr. KorandovaOlomouc, 77900, Czech Republic
Completed
Dr. Ivona ZikovaLouny, 44001, Czech Republic
Completed
Dr. Jaroslav DragonUsti nad Labem, 40010, Czech Republic
Completed
Dr. Sonja LacinovaChomutov, 43012, Czech Republic
Completed
Poliklinika Dermatologic DepartmentKutna Hora, 28401, Czech Republic
Completed
Dermatologicka ambulanceHlinsko, 539 01, Czech Republic
Completed
Praxis Fr. Dr. C. WeidnerGera, 07551, Germany
Completed
Praxisgemeinschaft AschoffplatzFreiburg, 79104, Germany
Completed
Praxis Hr. Dr. D.LichtenthaelerLübeck, 23558, Germany
Completed
Uniwersyteckie Centrum KliniczneGdansk, 80-952, Poland
Completed
Indywidualna Specjalistyczna Praktyka LekarskaGdansk, 80-177, Poland
Completed
SP Szpital Kliniczny Nr.1Wroclaw, 50-369, Poland
Completed
Kozni ordinacePraha, 15500, Czech Republic
Completed
Dr. SekerovaSlany, 27401, Czech Republic
Completed
Dr. TrestikSvitavy, 56802, Czech Republic
Completed
Dermatologicka ambulanceRychnov nad Kneznou, 516 01, Czech Republic

Primary Outcome

  • Overall cure rate comprising clinical cure and mycological cure microscopy + culture negative
    date_rangeTime Frame:
    14 days after end of treatment (=visit 3)
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Clinical cure rate
    date_rangeTime Frame:
    14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)
    enhanced_encryption
    Safety Issue:
    no
  • Culture negative
    date_rangeTime Frame:
    14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)
    enhanced_encryption
    Safety Issue:
    no
  • Microscopy negative
    date_rangeTime Frame:
    14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)
    enhanced_encryption
    Safety Issue:
    no
  • Relapse rate (overall cure at visit 3 but positive clinical or mycological findings at visit 4
    date_rangeTime Frame:
    3 and 6 months after end of treatment (=visit 4 and 5)
    enhanced_encryption
    Safety Issue:
    no
  • Mycological cure rate (microscopy + culture negative)
    date_rangeTime Frame:
    3 and 6 months after end of treatment (=visit 4 and 5)
    enhanced_encryption
    Safety Issue:
    no
  • Culture negative
    date_rangeTime Frame:
    6 months after end of treatment (=visit 5)
    enhanced_encryption
    Safety Issue:
    no
  • Incidence of adverse events
    date_rangeTime Frame:
    2 weeks, 3 and 6 months after end of treatment (=visit 3, 4, and 5)
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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