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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: September 17, 2018

Interventions

  • Drug: P-3058 10%
  • Drug: vehicle of P-3058 10%
  • Drug: amorolfine 5%

Arms, Groups and Cohorts

  • Experimental: P-3058 10%
    • P-3058 10%
  • Placebo Comparator: vehicle of P-3058 10%
    • vehicle of P-3058 10%
  • Active Comparator: amorolfine 5%
    • Loceryl®

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Polichem S.A.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Maurizio Caserini, MD, Study Director, Polichem S.A.

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