Mild to moderate distal subungual Onychomycosis caused by Dermatophytes MedDRA version: 19.0 Level: PT Classification code 10030338 Term: Onychomycosis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: P-3058 10%
Product Code: P-3058 10%
Pharmaceutical Form: Medicated nail lacquer
INN or Proposed INN: TERBINAFINE HYDROCHLORIDE
CAS Number: 78628-80-5
Current Sponsor code: P-3058
Concent
Sponsors
Polichem S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent before starting any study related procedures. - Patients aged 12 years and older of any race. - Males or females. - Patients with onychomycosis involving = 20% to = 50% of the area of the target big toenail. - Patients with a positive KOH examination in the screening target big toenail sample. Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 490 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 390
Exclusion criteria
Exclusion criteria: - Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period. - Presence of “yellow spikes” (defined as longitudinal streak extending from the free edge of the nail to the proximal edge) on the target nail. - Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail. - Presence of nail thickness exceeding 2 mm. - Patients with proximal subungual involvement (marker of immunosuppressed patient). - 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, lichen planus, immune dysfunction, collagen-vascular diseases, peripheral vascular disease. - Patients with life expectancy less than 2 years. - Chemotherapy, immunosuppressive therapy in the 12 weeks prior to Screening visit (V1). - Systemic corticosteroids, antimetabolites and immune-stimulants therapy in the 4 weeks prior to Screening visit (V1). - HIV infection or any other immunodeficiency. - Alcohol or substance abuse. - Patients with history of allergic reactions to terbinafine or its excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of P-3058 in the treatment of onychomycosis.;Secondary Objective: To evaluate the overall safety and the tolerability of P-3058. ;Primary end point(s): Complete cure rate defined as composite of negative KOH microscopy and negative culture for dermatophytes and no residual clinical involvement.;Timepoint(s) of evaluation of this end point: Week 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Responder rate. • Negative culture rate. • Mycological cure. • Overall safety and local tolerability during the entire study. ;Timepoint(s) of evaluation of this end point: Week 60. | — |
Countries
Belgium, Bulgaria, Czech Republic, Germany, Greece, Hungary, Iceland, Latvia, Lithuania, Poland, Russian Federation, Slovakia, Sweden
Contacts
Public ContactDirector, Clinical Development
Polichem S.A.
Outcome results
None listed