EUCTR2008-002707-10-ITActive, not recruitingNot Applicable
MULTICENTRE, RANDOMIZED, DOUBLE BLIND WITHIN FREQUENCY OF ADMINISTRATION, PLACEBO CONTROLLED, DOSE-FINDING, PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF 3 DOSES OF P-3058 NAIL LACQUER (5% o.d., 10% o.d., AND 10% o.w.) GIVEN FOR 52 WEEKS IN PATIENTS WITH ONYCHOMYCOSIS. - ND
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- POLICHEM
- Enrollment
- 336
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Written informed consent before starting any study related procedures Patients aged ≥12 up to 80 years old Males or females Outpatients Patients with established clinical diagnosis of mild-to-moderate distal sub-ungual onychomycosis, (i.e. involving ≥ 25% to ≤ 60% of the distal bed-adherent nail plate without involvement of the lunula) caused by dermatophytes, affecting at least one big toenail, Patients with positive KOH examination from the target big toenail obtained at screening Patients with positive culture for only dermatophyte/s in screening nail sample
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Patients with life expectancy less than 2 yearsPatients with history of cardiovascular,renal,neurologic,liver,immunologic or endocrine dysfunction if they are clinically significantPatients with a recent history of myocardial infarction and/or of heart failure or patients with any cardiac arrhythmia requiring drug therapyPatients with liver function impairmentPatients with kidney function impairmentHistory of cancer within the past 5 years,excluding treated basal cell carcinomaChemotherapy,immunosuppressive therapy in the 12 weeks prior to screening visitSystemic glucocorticosteroids,antimetabolites and immunostimulants therapy in the 4 weeks prior to screening visitAlcohol or substance abuseHIV infection or any other immunodeficiencyPatients unable to understand the procedures and purposes of the studyPatients with history of allergic reactions to terbinafine or its excipientsUse of an investigational drug or participation in an investigational study within 30 days prior to administration of study medication
- •Patients using nail polish or other nail cosmetic product on the concerned nails from at least 24 hours prior to study drug administration until the end of the studyPatients with target nail hyperkeratosis exceeding 4 mm in thicknessPatients with proximal subungual involvement(marker of immunosuppressed patient)Disease involving<25%or>60%of distal bed-adherent nail platePatients with mucocutaneous candidiasis,with white superficial onychomycosis,with onychomycosis caused by yeasts or non-dermatophytes mould,with Yellow spikes on the target nail(extension of fungal infection from distal to proximal part of nail),with lunula involvement(marker of immunosuppressed patient),with negative KOH examination at screening,with severe plantar or moccasin tinea pedis(defined by blistering,pustules or inability to ambulate),with nail abnormalities due to conditions like psoriasis or lichen planus,uncontrolled diabetes,with recurrent erysipela at screening visit [If erysipela infection occurs during the study, the patient is allowed to continue the study and to be treated with antibiotic therapy (penicillin)]Use of systemic antifungal drugs in the 6 months prior to screening visit,of topical products containing terbinafine in the 3 months prior to screening visit,of topical antifungal drugs(other than terbinafine)in the four weeks prior to screening visit
- •Additional exclusion criteria for females only
- •Exclusion criteria during the study:Any topical product on nails is not allowed.Topical antifungal treatments,other than terbinafine,will be allowed on any other skin area,only once during the study,for short-term(≤4 weeks)treatment of mycosis
Investigators
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