Back to resultsClinical Trial on Onychomycosis With P-3058 Nail Solution in Pediatric Population
Primary Purpose
Onychomycosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
P-3058
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis
Eligibility 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.
Sites / Locations
- Polichem Investigative site
- Polichem Investigative Site
- Polichem Investigative site
- Polichem Investigative Site
- Polichem Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
P-3058
Arm Description
Outcomes
Primary Outcome Measures
Local tolerability
Local tolerability at all treated nails by means of the Severity Score for Skin Irritation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02547701
Brief Title
Clinical Trial on Onychomycosis With P-3058 Nail Solution in Pediatric Population
Official Title
Multicentre, Open Label Study to Assess the Tolerability of P-3058 Nail Solution in Paediatric Patients Affected by Mild-to-moderate Onychomycosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Polichem S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
P-3058
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
P-3058
Primary Outcome Measure Information:
Title
Local tolerability
Description
Local tolerability at all treated nails by means of the Severity Score for Skin Irritation
Time Frame
from week 4 up to maximum week 48 of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurizio Caserini, MD
Organizational Affiliation
Polichem SA
Official's Role
Study Director
Facility Information:
Facility Name
Polichem Investigative site
City
One Investigational Site
Country
Belgium
Facility Name
Polichem Investigative Site
City
One Investigational Site
Country
Germany
Facility Name
Polichem Investigative site
City
One Investigational Site
Country
Italy
Facility Name
Polichem Investigative Site
City
One Investigational Site
Country
Latvia
Facility Name
Polichem Investigative Site
City
One Investigational Site
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial on Onychomycosis With P-3058 Nail Solution in Pediatric Population
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