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

NCT02549001 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 953

Last updated 2018-09-26

No results posted yet for this study

Summary

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

Conditions

  • Onychomycosis

Interventions

DRUG

P-3058 10%

DRUG

vehicle of P-3058 10%

DRUG

amorolfine 5%

Sponsors & Collaborators

  • Polichem S.A.

    lead INDUSTRY

Principal Investigators

  • Maurizio Caserini, MD · Polichem S.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-20
Primary Completion
2018-09-17
Completion
2018-09-17

Countries

  • Belgium
  • Bulgaria
  • Czechia
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Latvia
  • Lithuania
  • Poland
  • Russia
  • Slovakia
  • Sweden

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02549001 on ClinicalTrials.gov