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

• Register: EUCTR
• Last refreshed on: 1 October 2018
• Main ID: EUCTR2015-000561-31-LV
• Date of registration: 13/05/2015
• Prospective Registration: Yes
• Primary sponsor: Polichem S.A.
• Public title: Study to evaluate the efficacy and safety of P-3058 10% solution in the treatment of nails affected by fungi.
• Scientific title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL, VEHICLE-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF P-3058 10% NAIL SOLUTION IN THE TREATMENT OF ONYCHOMYCOSIS
• Date of first enrolment: 01/06/2015
• Target sample size: 980
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000561-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: yes; Other specify the comparator: P-3058 Vehicle, P-3058 identical nail solution without active and amorolfine 5% nail lacquer; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Bulgaria, Czech Republic, Germany, Greece, Hungary, Iceland, Latvia, Lithuania, Poland, Russian Federation, Slovakia, Sweden

Contacts

• Name: Director, Clinical Development
• Affiliation: Polichem S.A.

• Name: Director, Clinical Development
• Affiliation: Polichem S.A.

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Mild to moderate distal subungual Onychomycosis caused by Dermatophytes
MedDRA version: 20.0 Level: PT Classification code 10030338 Term: Onychomycosis System Organ Class: 10021881 - Infections and infestations

Intervention(s)

Product Name: P-3058 10%
Product Code: P-3058 10%
Pharmaceutical Form: Medicated nail lacquer
INN or Proposed INN: TERBINAFINE HYDROCHLORIDE
CAS Number: 78628-80-5
Current Sponsor code: P-3058
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Medicated nail lacquer
Route of administration of the placebo: Topical use (Noncurrent)

Trade Name: Loceryl 5% Medicated nail lacquer
Pharmaceutical Form: Medicated nail lacquer
INN or Proposed INN: Amorolfine hydrochloride
CAS Number: 78613-35-1
Current Sponsor code: amorolfine 5% nail lacquer
Other descriptive name: AMOROLFINE
Concentration unit: % percent
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Primary end point(s): Complete cure rate defined as composite of negative KOH microscopy and negative culture for dermatophytes and no residual clinical involvement.

Secondary Objective: To evaluate the overall safety and the tolerability of P-3058.

Timepoint(s) of evaluation of this end point: Week 60

Main Objective: To evaluate the efficacy of P-3058 in the treatment of onychomycosis.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 60.

Secondary end point(s): • Responder rate.
• Mycological cure.
• Overall safety and local tolerability during the entire study.

Secondary ID(s)

2015-000561-31-HU

PM1331

Source(s) of Monetary Support

Polichem S.A.