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

September 25, 2018 updated by: Polichem S.A.

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

The purpose of this study is to determine whether P-3058 nail solution is a safe and effective treatment for onychomycosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

953

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Multiple Locations, Belgium
        • Polichem Investigative Site
  • Bulgaria
      • Multiple Locations, Bulgaria
        • Polichem Investigative Site
  • Czechia
      • Multiple Locations, Czechia
        • Polichem Investigative Site
  • Germany
      • Multiple Locations, Germany
        • Polichem Investigative Site
  • Greece
      • Multiple Locations, Greece
        • Polichem Investigative Site
  • Hungary
      • Multiple Locations, Hungary
        • Polichem Investigative Site
  • Iceland
      • Various Cities In Iceland, Iceland
        • Polichem Investigative Site
  • Latvia
      • Multiple Locations, Latvia
        • Polichem Investigative Site
  • Lithuania
      • Multiple Locations, Lithuania
        • Polichem Investigative Site
  • Poland
      • Multiple Locations, Poland
        • Polichem Investigative Site
  • Russian Federation
      • Multiple Locations, Russian Federation
        • Polichem Investigative Site
  • Slovakia
      • Multiple Locations, Slovakia
        • Polichem Investigative Site
  • Sweden
      • Multiple Locations, Sweden
        • Polichem Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: P-3058 10%
Drug: P-3058 10%
Placebo Comparator: vehicle of P-3058 10%
Drug: vehicle of P-3058 10%
Active Comparator: amorolfine 5%
Loceryl®
Drug: amorolfine 5%
Other Names:
  • Loceryl®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete cure of target great toenail defined as negative KOH microscopy, negative culture for dermatophytes and target nail totally clear.
Time Frame: Week 60
Week 60

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Week 60
Negative culture rate for dermatophytes of the target nail.
Time Frame: Week 60
Week 60
Mycological cure defined as negative KOH microscopy and negative culture for dermatophytes of the target nail.
Time Frame: Week 60
Week 60
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
Week 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Polichem S.A.

Investigators

  • Study Director: Maurizio Caserini, MD, Polichem S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2015

Primary Completion (Actual)

September 17, 2018

Study Completion (Actual)

September 17, 2018

Study Registration Dates

First Submitted

September 8, 2015

First Submitted That Met QC Criteria

September 10, 2015

First Posted (Estimate)

September 14, 2015

Study Record Updates

Last Update Posted (Actual)

September 26, 2018

Last Update Submitted That Met QC Criteria

September 25, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM1331
  • 2015-000561-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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