Trial | NCT02547701  Report issue

Title

Clinical Trial on Onychomycosis With P-3058 Nail Solution in Pediatric Population
Multicentre, Open Label Study to Assess the Tolerability of P-3058 Nail Solution in Paediatric Patients Affected by Mild-to-moderate Onychomycosis

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
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.
Study Started
Aug 31
2014
Primary Completion
Sep 30
2017
Study Completion
Sep 30
2017
Last Update
Mar 08
2018

Drug P-3058

P-3058 Experimental

Criteria 

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.
No Results Posted