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: 19.0Level: PTClassification code 10030338Term: OnychomycosisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-15
• Study Completion: 2018-09-17
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 953

Inclusion Criteria

1)Written informed consent before starting any study related procedures.
2)Patients aged 12 years and older of any race.
3)Males or females.
4)Outpatients.
5)Clinically diagnosed mild-to-moderate distal lateral subungual onychomycosis (DLSO) of at least one big toenail (the target nail) at the Screening visit (V1), confirmed by the Independent Panel of Reviewers.
6)Patients with onychomycosis involving = 20% to = 50% of the area of the target big toenail.
7)Patients with a positive KOH examination in the screening target big toenail sample.
8)Patients with positive culture for dermatophyte(s) or positive mixed dermatophyte(s)/Candida culture in the screening target big toenail sample.
9)Evidence of target big toenail growth reported by the patient defined as at least monthly nail clipping.

Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 590
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 amorolfine or to their 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>• Negative culture rate. <br>• Mycological cure.<br>• Overall safety and local tolerability during the entire study. ;Timepoint(s) of evaluation of this end point: Week 60.