Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Toenail Onychomycosis
Phase 3
Completed
- Conditions
- Onychomycosis
- Interventions
- Registration Number
- NCT02549001
- Lead Sponsor
- Polichem S.A.
- Brief Summary
The purpose of this study is to determine whether P-3058 nail solution is a safe and effective treatment for onychomycosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 953
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description amorolfine 5% amorolfine 5% Loceryl® P-3058 10% P-3058 10% P-3058 10% vehicle of P-3058 10% vehicle of P-3058 10% vehicle of P-3058 10%
- Primary Outcome Measures
Name Time Method Complete cure of target great toenail defined as negative KOH microscopy, negative culture for dermatophytes and target nail totally clear. Week 60
- Secondary Outcome Measures
Name Time Method Negative culture rate for dermatophytes of the target nail. Week 60 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 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
Trial Locations
- Locations (1)
Polichem Investigative Site
🇸🇪Multiple Locations, Sweden