EUCTR2008-002707-10-LVActive, 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
Polichem SA0 sites336 target enrollmentStarted: January 5, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- 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 history of cardiovascular, renal, neurologic, liver, immunologic or endocrine dysfunction if they are clinically significant.
- •A clinically significant disease is defined as one which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient’s ability to participate in the study.
- •Patients with a recent history (< 1 year) of myocardial infarction and/or (< 3 years) of heart failure or patients with any cardiac arrhythmia requiring drug therapy
- •Patients with liver function impairment AST, ALT more than twice above the upper limit of reference range
- •Patients with kidney function impairment serum creatinine more than twice above the upper limit of reference range
- •History of cancer within the past 5 years, excluding treated basal cell carcinoma
- •Chemotherapy, immunosuppressive therapy in the 12 weeks prior to screening visit
- •Systemic glucocorticosteroids, antimetabolites and immunostimulants therapy in the 4 weeks prior to screening visit
- •Alcohol or substance abuse
- •HIV infection or any other immunodeficiency
- •Patients unable to understand the procedures and purposes of the study
- •Patients with history of allergic reactions to terbinafine or its excipients
- •Use 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 study
- •Patients with target nail hyperkeratosis exceeding 4 mm in thickness
- •Patients with proximal subungual involvement (marker of immunosuppressed patient)
- •Disease involving <25% or >60% of distal bed-adherent nail plate
- •Patients with mucocutaneous candidiasis
- •Patients with white superficial onychomycosis
- •Patients with onychomycosis caused by yeasts or non-dermatophytes mould
- •Patients with Yellow spikes on the target nail (extension of fungal infection from distal to proximal part of nail)
- •Patients with lunula involvement (marker of immunosuppressed patient)
- •Patients with negative KOH examination at screening
- •Patients with severe plantar or moccasin tinea pedis (defined by blistering, pustules or inability to ambulate)
- •Patients with nail abnormalities due to conditions like psoriasis or lichen planus
- •Patients with uncontrolled diabetes
- •Patients 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
- •Use of topical products containing terbinafine in the 3 months prior to screening visit
- •Use of topical antifungal drugs (other than terbinafine) in the four weeks prior to screening visit
- •Breast-feeding patients
- •Positive urine pregnancy test at screening
- •Women of child-bearing potential or in menopause for less than 1 year not using a reliable method of contraception.
Investigators
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