Clinical Trial on Onychomycosis With P-3058 Nail Solution in Pediatric Population

Polichem S.A.

Status and phase

Completed

Phase 3

Conditions

Onychomycosis

Treatments

Drug: P-3058

Study type

Interventional

Funder types

Industry

Identifiers

NCT02547701

2013-005595-17 (EudraCT Number)

PM Ped-004

Details and patient eligibility

About

Pediatric patients affected by mild-to-moderate distal subungual onychomycosis (DSO) or affected by white superficial onychomycosis (WSO), due to dermatophytes, will be treated topically with P-3058 nail solution according to the appropriate treatment schedule.

Enrollment

20 patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 2 to 17 years
Males and females
Clinical diagnosis of mild-to-moderate distal sub-ungual onychomycosis without spikes/dermatophytoma and without lunula involvement or white superficial onychomycosis.
Positive mycroscopy examination from the target nail at screening.
Positive culture for dermatophyte from the target nail at screening.

Exclusion criteria

Patients with onychomycosis caused by yeasts or non-dermatophytes mould.
Patients with nail psoriasis.
Patients with nail changes due to eczema, lichen planus or alopecia areata.
Patients with one-hand two-foot syndrome.
Patients with immunodeficiency disorder or use of immune suppressive therapy 3 months prior to screening visit or need for it.
Use of systemic antifungal drugs in the 6 months prior to screening visit.
Use of topical nail antifungal drugs in the four weeks prior to screening visit.