Onychomycosis
Conditions
Keywords
Onychomycosis, Nail fungus
Brief summary
The purpose of this study is to determine whether P-3058 nail solution is a safe and effective treatment for onychomycosis.
Interventions
DRUGamorolfine 5%
DRUGP-3058 10%
DRUGvehicle of P-3058 10%
Sponsors
Polichem S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Patients aged 12 years and older of any race. * Males or females. * Patients with onychomycosis involving ≥ 20% to ≤ 50% of target big toenail. * Patients with a positive KOH examination and culture positive for dermatophyte
Exclusion criteria
* Presence of yellow spikes on the target nail. * Presence of dermatophytoma on the target nail. * Presence of nail thickness exceeding 2 mm. * Patients with proximal subungual involvement * Patients with severe plantar or moccasin tinea pedis * Patients with nail abnormalities due to other conditions * 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. * Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete cure of target great toenail defined as negative KOH microscopy, negative culture for dermatophytes and target nail totally clear. | Week 60 |
Secondary
| Measure | Time frame |
|---|---|
| Responder rate of the target toenail, defined as negative KOH microscopy, negative culture for dermatophytes and ≤10% residual involvement of the target toenail. | Week 60 |
| Negative culture rate for dermatophytes of the target nail. | Week 60 |
| Mycological cure defined as negative KOH microscopy and negative culture for dermatophytes of the target nail. | Week 60 |
| Overall safety by recording any AE during the entire study duration and the local tolerability by means of severity scores for skin irritation. | Week 60 |
Countries
Belgium, Bulgaria, Czechia, Germany, Greece, Hungary, Iceland, Latvia, Lithuania, Poland, Russia, Slovakia, Sweden
Outcome results
None listed