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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Onychomycosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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P-3058

Group Type EXPERIMENTAL

P-3058

Intervention Type DRUG

Interventions

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P-3058

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No