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

March 7, 2018 updated by: Polichem S.A.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • One Investigational Site, Belgium
        • Polichem Investigative Site
  • Germany
      • One Investigational Site, Germany
        • Polichem Investigative Site
  • Italy
      • One Investigational Site, Italy
        • Polichem Investigative Site
  • Latvia
      • One Investigational Site, Latvia
        • Polichem Investigative Site
  • Spain
      • One Investigational Site, Spain
        • Polichem Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: P-3058
Drug: P-3058

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from week 4 up to maximum week 48 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Polichem S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

September 8, 2015

First Submitted That Met QC Criteria

September 10, 2015

First Posted (Estimate)

September 11, 2015

Study Record Updates

Last Update Posted (Actual)

March 8, 2018

Last Update Submitted That Met QC Criteria

March 7, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM Ped-004
  • 2013-005595-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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