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Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Toenail Onychomycosis

Primary Purpose

Onychomycosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
P-3058 10%
vehicle of P-3058 10%
amorolfine 5%
Sponsored by
Polichem S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis focused on measuring Onychomycosis, Nail fungus

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Written informed consent
  • Patients aged 12 years and older of any race.
  • Males or females.
  • Patients with onychomycosis involving ≥ 20% to ≤ 50% of target big toenail.
  • Patients with a positive KOH examination and culture positive for dermatophyte

Exclusion Criteria:

  • Presence of "yellow spikes" on the target nail.
  • Presence of dermatophytoma on the target nail.
  • Presence of nail thickness exceeding 2 mm.
  • Patients with proximal subungual involvement
  • Patients with severe plantar or moccasin tinea pedis
  • Patients with nail abnormalities due to other conditions
  • Patients with life expectancy less than 2 years.
  • Chemotherapy, immunosuppressive therapy in the 12 weeks prior to Screening visit (V1).
  • Systemic corticosteroids, antimetabolites and immune-stimulants therapy in the 4 weeks prior to Screening visit (V1).
  • HIV infection or any other immunodeficiency.
  • Alcohol or substance abuse.
  • Patients with history of allergic reactions to terbinafine or its excipients.
  • Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.

Sites / Locations

  • Polichem Investigative Site
  • Polichem Investigative Site
  • Polichem Investigative Site
  • Polichem Investigative Site
  • Polichem Investigative Site
  • Polichem Investigative Site
  • Polichem Investigative Site
  • Polichem Investigative Site
  • Polichem Investigative Site
  • Polichem Investigative Site
  • Polichem Investigative Site
  • Polichem Investigative Site
  • Polichem Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

P-3058 10%

vehicle of P-3058 10%

amorolfine 5%

Arm Description

P-3058 10%

vehicle of P-3058 10%

Loceryl®

Outcomes

Primary Outcome Measures

Complete cure of target great toenail defined as negative KOH microscopy, negative culture for dermatophytes and target nail totally clear.

Secondary Outcome Measures

Responder rate of the target toenail, defined as negative KOH microscopy, negative culture for dermatophytes and ≤10% residual involvement of the target toenail.
Negative culture rate for dermatophytes of the target nail.
Mycological cure defined as negative KOH microscopy and negative culture for dermatophytes of the target nail.
Overall safety by recording any AE during the entire study duration and the local tolerability by means of severity scores for skin irritation.

Full Information

First Posted
September 8, 2015
Last Updated
September 25, 2018
Sponsor
Polichem S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02549001
Brief Title
Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Toenail Onychomycosis
Official Title
A Multicenter, Randomized, Double-blind, Parallel, Vehicle-controlled Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Onychomycosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 20, 2015 (Actual)
Primary Completion Date
September 17, 2018 (Actual)
Study Completion Date
September 17, 2018 (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
The purpose of this study is to determine whether P-3058 nail solution is a safe and effective treatment for onychomycosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
Keywords
Onychomycosis, Nail fungus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
953 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P-3058 10%
Arm Type
Experimental
Arm Description
P-3058 10%
Arm Title
vehicle of P-3058 10%
Arm Type
Placebo Comparator
Arm Description
vehicle of P-3058 10%
Arm Title
amorolfine 5%
Arm Type
Active Comparator
Arm Description
Loceryl®
Intervention Type
Drug
Intervention Name(s)
P-3058 10%
Intervention Type
Drug
Intervention Name(s)
vehicle of P-3058 10%
Intervention Type
Drug
Intervention Name(s)
amorolfine 5%
Other Intervention Name(s)
Loceryl®
Primary Outcome Measure Information:
Title
Complete cure of target great toenail defined as negative KOH microscopy, negative culture for dermatophytes and target nail totally clear.
Time Frame
Week 60
Secondary Outcome Measure Information:
Title
Responder rate of the target toenail, defined as negative KOH microscopy, negative culture for dermatophytes and ≤10% residual involvement of the target toenail.
Time Frame
Week 60
Title
Negative culture rate for dermatophytes of the target nail.
Time Frame
Week 60
Title
Mycological cure defined as negative KOH microscopy and negative culture for dermatophytes of the target nail.
Time Frame
Week 60
Title
Overall safety by recording any AE during the entire study duration and the local tolerability by means of severity scores for skin irritation.
Time Frame
Week 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent Patients aged 12 years and older of any race. Males or females. Patients with onychomycosis involving ≥ 20% to ≤ 50% of target big toenail. Patients with a positive KOH examination and culture positive for dermatophyte Exclusion Criteria: Presence of "yellow spikes" on the target nail. Presence of dermatophytoma on the target nail. Presence of nail thickness exceeding 2 mm. Patients with proximal subungual involvement Patients with severe plantar or moccasin tinea pedis Patients with nail abnormalities due to other conditions Patients with life expectancy less than 2 years. Chemotherapy, immunosuppressive therapy in the 12 weeks prior to Screening visit (V1). Systemic corticosteroids, antimetabolites and immune-stimulants therapy in the 4 weeks prior to Screening visit (V1). HIV infection or any other immunodeficiency. Alcohol or substance abuse. Patients with history of allergic reactions to terbinafine or its excipients. Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurizio Caserini, MD
Organizational Affiliation
Polichem S.A.
Official's Role
Study Director
Facility Information:
Facility Name
Polichem Investigative Site
City
Multiple Locations
Country
Belgium
Facility Name
Polichem Investigative Site
City
Multiple Locations
Country
Bulgaria
Facility Name
Polichem Investigative Site
City
Multiple Locations
Country
Czechia
Facility Name
Polichem Investigative Site
City
Multiple Locations
Country
Germany
Facility Name
Polichem Investigative Site
City
Multiple Locations
Country
Greece
Facility Name
Polichem Investigative Site
City
Multiple Locations
Country
Hungary
Facility Name
Polichem Investigative Site
City
Various Cities In Iceland
Country
Iceland
Facility Name
Polichem Investigative Site
City
Multiple Locations
Country
Latvia
Facility Name
Polichem Investigative Site
City
Multiple Locations
Country
Lithuania
Facility Name
Polichem Investigative Site
City
Multiple Locations
Country
Poland
Facility Name
Polichem Investigative Site
City
Multiple Locations
Country
Russian Federation
Facility Name
Polichem Investigative Site
City
Multiple Locations
Country
Slovakia
Facility Name
Polichem Investigative Site
City
Multiple Locations
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Toenail Onychomycosis

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