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

Onychomycosis Clinical Trial

Official title:

Multicentre, Open Label Study to Assess the Tolerability of P-3058 Nail Solution in Paediatric Patients Affected by Mild-to-moderate Onychomycosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547701
• Other study ID #: PM Ped-004
• Secondary ID: 2013-005595-17
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2015
• Last updated: March 7, 2018
• Start date: August 2014
• Est. completion date: September 2017

Study information

• Verified date: March 2018
• Source: Polichem S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• P-3058

Locations

Country	Name	City	State
Belgium	Polichem Investigative site	One Investigational Site
Germany	Polichem Investigative Site	One Investigational Site
Italy	Polichem Investigative site	One Investigational Site
Latvia	Polichem Investigative Site	One Investigational Site
Spain	Polichem Investigative Site	One Investigational Site

Sponsors (1)

Lead Sponsor	Collaborator
Polichem S.A.

Countries where clinical trial is conducted

Belgium,  Germany,  Italy,  Latvia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local tolerability	Local tolerability at all treated nails by means of the Severity Score for Skin Irritation	from week 4 up to maximum week 48 of treatment