Study to evaluate the efficacy and safety of P-3058 10% solution in the treatment of nails affected by fungi.

Phase 1

• Conditions: Mild to moderate distal subungual Onychomycosis caused by Dermatophytes; MedDRA version: 20.0Level: PTClassification code 10030338Term: OnychomycosisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-000561-31-PL
• Lead Sponsor: Polichem S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-23
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 980

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): • Responder rate. <br>• Mycological cure.<br>• Overall safety and local tolerability during the entire study. ;Timepoint(s) of evaluation of this end point: Week 60.