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-LV
• Lead Sponsor: Polichem S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-13
• Last Update Posted: 1 October 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.
- Patients with positive culture for dermatophyte(s) or positive mixed dermatophyte(s)/Candida culture in the screening target big toenail sample.
- 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: 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