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

NCT02547701 | Completed Phase 3

• 2 other identifiers: PM Ped-0042013-005595-17
• Study Type: interventional
• Target: 20
• Locations: 5 countries
• Sites: 5

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.

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (1)

• Local tolerability

  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

Study Arms (1)

P-3058

EXPERIMENTAL

Drug: P-3058

Interventions

P-3058 DRUG

P-3058

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Polichem S.A.: lead

Study Sites (5)

Polichem Investigative site

One Investigational Site, Belgium

Location

Polichem Investigative Site

One Investigational Site, Germany

Location

Polichem Investigative site

One Investigational Site, Italy

Location

Polichem Investigative Site

One Investigational Site, Latvia

Location

Polichem Investigative Site

One Investigational Site, Spain

Location

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Maurizio Caserini, MD

  Polichem SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: September 11, 2015
• Study Start: August 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 8, 2018

Record last verified: 2018-03

Locations

BE (1); DE (1); ES (1); LA (1); IT (1)