Mild to moderate distal subungual Onychomycosis due to Dermatophytes. MedDRA version: 14.1 Level: PT Classification code 10030338 Term: Onychomycosis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: P-3058 5%
Product Code: P-3058 5%
Pharmaceutical Form: Medicated nail lacquer
INN or Proposed INN: Terbinafine
CAS Number: 78628805
Current Sponsor code: P-3058
Concentration unit: % per
Sponsors
Polichem SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Availability of a legally effective written informed consent before starting any study related procedures. In case of minors, the patient and both of his/her parents/legal representatives have to sign the written informed consent • Males or females patients aged =12 up to 80 years old • 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 dermatophyte/s in screening nail sample Are the trial subjects under 18? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 176 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
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 (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of different doses of P-3058 compared to placebo in the treatment of onychomycosis at the end of follow up (week 76). ;Secondary Objective: • To evaluate the shape and the location of the dose response-curve of the efficacy outcome (responders rate). • To determine the maximal dose beyond which additional benefit would be unlikely to occur. ;Primary end point(s): The primary end-point is the responders rate as evaluated by the central, blinded Assessor at week 76 (end of follow up) This is defined as patients with conversion to negative of culture and of microscopic KOH examination and with decrease of affected nail area to =10% of total. ;Timepoint(s) of evaluation of this end point: End of follow up (at week 76). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end-points: •Cure rate defined as complete replacement of the affected nail by new healthy nail, as evaluated by a central, blinded Assessor, accompanied by conversion to negative of culture and of microscopic KOH examination at week 16, 28, 40, 52 (end of treatment), 64 and 76 •Conversion to negative of culture at week 4, 16, 28, 40, 52, 64 and 76 •Conversion to negative of microscopic finding on KOH preparation at week 4, 16, 28, 40, 52, 64 and 76 •Determination of growth rate of healthy nail at week 16, 28, 40, 52, 64 and 76 by the central, blinded Assessor •Responders as evaluated by the central, blinded Assessor at week 16, 28, 40, 52 and 64 •Responders as evaluated by the local Investigator at week 16, 28, 40, 52, 64 and 76 •Decrease of the affected nail area to = 10% of the total at week 4,16, 28, 40, 52, 64 and 76 •Time to reach the efficacy outcome responder •Time to reach the efficacy outcome cure •Rate of relapse at week 76 (at least one among the following: affected target nail area >10%, culture positive, KOH positive), in patients responders at week 52 •Rate of responders at weeks 64 and 76 among patients non-responders at week 52 •Acceptance of therapy by patient •Overall safety evaluation;Timepoint(s) of evaluation of this end point: Cure rate at week 16, 28, 40, 52, 64 and 76 •Conversion to negative of culture at week 4, 16, 28, 40, 52, 64 and 76 •Conversion to negative of KOH microscopy at week 4, 16, 28, 40, 52, 64 and 76 •Growth rate of healthy nail at week 16, 28, 40, 52, 64 and 76 •Responders, evaluated by the blinded Assessor at week 16, 28, 40, 52 and 64 •Responders, evaluated by the local Investigator at week 16, 28, 40, 52, 64 and 76 •Decrease of the affected nail area to = 10% of the total at week 4,16, 28, 40, 52, 64 and 76 •Rate of relapse at week 76 in patients responders at week 52 •Rate of responders at weeks 64 and 76 among patients non-responders at week 52 •Therapy accep | — |
Countries
Canada, Czech Republic, France, Germany, Italy, Latvia, Poland
Contacts
Public ContactDirector, Clinical Development
Polichem SA
Outcome results
None listed