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

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 aim of this phase III study is to establish the efficacy and safety of P-3058 (terbinafine 10% nail solution) topically administered once weekly in patients with onychomycosis in comparison to the Vehicle in a double-blind fashion. The overall treatment period will be of 48 weeks.

Study Overview

• Status: Withdrawn
• Conditions: Onychomycosis of Toenail
• Intervention / Treatment: Drug: P-3058 (terbinafine hydrochloride 10%); Drug: Vehicle of P-3058

Detailed Description

The study will consist of a screening phase, a treatment phase of 48 weeks and a 12-week follow-up. Patients affected by mild to-moderate distal lateral subungual onychomycosis (DLSO) on a target great toenail will be included in the study. Clinical as well as mycology assessments will be performed throughout the whole study. Safety will be monitored by recording any adverse event and evaluating local tolerability.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2G 1B1
      • Polichem Investigation site no 3
    • Edmonton, Alberta, Canada, T5K 1X3
      • Polichem Investigation Site no 8
  • Ontario
    • Mississauga, Ontario, Canada, L5H 1G9
      • Polichem Investigation Site no 13
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • Polichem Investigation Site no 9
    • Toronto, Ontario, Canada, M9W 4L6
      • Polichem Investigation Site no 7
• United States
  • California
    • North Hollywood, California, United States, 91606
      • Polichem Investigation Site no 45
    • Oceanside, California, United States, 92056
      • Polichem Investigation Site no 5
    • San Diego, California, United States, 92123
      • Polichem Investigation Site no 39
  • Florida
    • Hialeah, Florida, United States, 33012
      • Polichem Investigation Site no 2
    • Jacksonville, Florida, United States, 32204
      • Polichem Investigation Site no 23
    • Miami, Florida, United States, 33176
      • Polichem Investigation Site no 22
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Polichem Investigation Site no 52
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Polichem Investigation Site no 41
  • New York
    • New York, New York, United States, 10025
      • Polichem Investigation site no 1
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Polichem Investigation Site no 44
  • Oklahoma
    • Norman, Oklahoma, United States, 71071
      • Polichem Investigation Site no 40
    • Oklahoma City, Oklahoma, United States, 73103
      • Polichem Investigation Site no 14
  • Texas
    • Austin, Texas, United States, 78731
      • Polichem Investigation Site no 10
    • Dallas, Texas, United States, 75234
      • Polichem Investigation Site no 11
    • Dallas, Texas, United States, 75246
      • Polichem Investigation Site no 43
    • Fort Worth, Texas, United States, 76107
      • Polichem Investigation Site no 6
    • Houston, Texas, United States, 77055
      • Polichem Investigation Site no 12
    • Houston, Texas, United States, 77081
      • Polichem Investigation Site no 4
    • Pflugerville, Texas, United States, 78660
      • Polichem Investigation Site no 42
    • San Antonio, Texas, United States, 78229
      • Polichem Investigation Site no 53
    • San Antonio, Texas, United States, 78249
      • Polichem Investigation Site no 54

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent before starting any study related procedures.
• Patients aged 12 and older of any race.
• Males or females.
• Outpatients.
• Clinically diagnosed mild-to-moderate distal lateral subungual onychomycosis (DLSO) of at least one great toenail (the "target nail") at the Screening visit (V1).
• Patients with onychomycosis involving ≥ 20% to ≤ 50% of the area of the target great toenail.
• Patients with a positive KOH examination.
• Patients with positive culture for dermatophyte(s).
• Evidence of target great toenail growth reported by the patient defined as at least monthly nail clipping.

Exclusion Criteria:

• Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
• Patients with history of allergic reactions to terbinafine or its excipients.
• Use of any investigational drug/device or participation in a previous clinical trial within four weeks prior to Screening visit (V1).
• Patients using nail polish or other nail cosmetic product on the concerned nails from at least 24 hours prior to Screening visit (V1) until the end of the study.
• Use of systemic antifungal drugs in the 24 weeks prior to Screening visit (V1) or non-responsive to systemic antifungal therapy for onychomycosis.
• Nail application of topical antifungal drugs or device in the 4 weeks prior to Screening visit (V1).
• Presence of any nail infections other than dermatophyte.
• Presence of onychodystrophy that could interfere with clinical assessments.
• 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 (marker of immunosuppressed patient).
• Patients with severe plantar or moccasin tinea pedis (defined by blistering, pustules or inability to ambulate).
• Patients with nail abnormalities due to conditions like psoriasis, lichen planus, immune dysfunction, collagen-vascular diseases, peripheral vascular disease.
• 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/parents (or legal guardian) unable to understand the procedures and purposes of the study.
• Any other condition that, in the opinion of the Investigator, would prevent the subject from effectively participating in the study, place the subject at risk or effect the assessment of efficacy and safety of the study medication.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle	Drug: Vehicle of P-3058; Patients will apply the Vehicle of P-3058 once weekly in a double blind fashion. The overall treatment phase is of 48 weeks.
Experimental: P-3058	Drug: P-3058 (terbinafine hydrochloride 10%); Patients will apply the P-3058 nail solution once weekly in a double blind fashion. The overall treatment phase is of 48 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of complete cure at Week 60	Defined as composite of negative KOH microscopy and negative culture for dermatophytes and no residual clinical involvement (nail totally clear) of the target nail.	Baseline - Week 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder rate at Week 60	Defined as negative Potassium Hydroxide (KOH) microscopy and negative culture for dermatophytes and ≤ 10% residual involvement of the target toenail)	Baseline - Week 60
Mycological cure rate at Week 60	Defined as negative Potassium Hydroxide (KOH) microscopy and negative culture for dermatophytes of the target nail.	Baseline - Week 60

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative culture rate for dermatophytes of the target nail at Week 60		Baseline - Week 60
Onychomycosis quality of life	The questionnaire ONYCHO (Toenail from Mapi Research Trust) will be administered at Week 0, at Week 48 and at Week 60 or at the discontinuation visit.	Baseline - Week 48, Week 60

Collaborators and Investigators

• Sponsor: Polichem S.A.
• Collaborators: Almirall, S.A.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2017
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): January 10, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: terbinafine nail solution; nail fungal infection; topical antifungal drug
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antifungal Agents; Terbinafine
• Other Study ID Numbers: PM1328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No