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Completed

NCT Number: NCT02547701

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

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.

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Key information

Conditions

Onychomycosis Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Nail Diseases Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Polichem Investigative site, One Investigational Site, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

P-3058

Drug

Primary outcomes

  1. Local tolerability

    Time frame: from week 4 up to maximum week 48 of treatment

    Local tolerability at all treated nails by means of the Severity Score for Skin Irritation

Sponsors and collaborators

Lead sponsor

Polichem S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 11, 2015
Registry last updated
Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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