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

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ClinicalTrials.gov Identifier: NCT02547701
Recruitment Status : Completed
First Posted : September 11, 2015
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Polichem S.A.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Onychomycosis Drug: P-3058 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentre, Open Label Study to Assess the Tolerability of P-3058 Nail Solution in Paediatric Patients Affected by Mild-to-moderate Onychomycosis
Actual Study Start Date : August 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: P-3058 Drug: P-3058


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547701


Locations
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Belgium
Polichem Investigative site
One Investigational Site, Belgium
Germany
Polichem Investigative Site
One Investigational Site, Germany
Italy
Polichem Investigative site
One Investigational Site, Italy
Latvia
Polichem Investigative Site
One Investigational Site, Latvia
Spain
Polichem Investigative Site
One Investigational Site, Spain
Sponsors and Collaborators
Polichem S.A.
Investigators
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Study Director: Maurizio Caserini, MD Polichem SA
More Information
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Responsible Party: Polichem S.A.
ClinicalTrials.gov Identifier: NCT02547701    
Other Study ID Numbers: PM Ped-004
2013-005595-17 ( EudraCT Number )
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
 Infection
Mycoses
Nail Diseases
Skin Diseases