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

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Polichem S.A.

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.