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

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ClinicalTrials.gov Identifier: NCT03094468
Recruitment Status : Withdrawn (Project development priorities changed)
First Posted : March 29, 2017
Last Update Posted : January 10, 2018
Sponsor:
Collaborator:
Almirall, S.A.
Information provided by (Responsible Party):
Polichem S.A.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Onychomycosis of Toenail Drug: P-3058 (terbinafine hydrochloride 10%) Drug: Vehicle of P-3058 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Vehicle-controlled
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double blind
Primary Purpose: Treatment
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
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

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Arms and Interventions
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Arm Intervention/treatment
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of complete cure at Week 60 [ Time Frame: Baseline - 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.


Secondary Outcome Measures :
  1. Responder rate at Week 60 [ Time Frame: Baseline - Week 60 ]
    Defined as negative Potassium Hydroxide (KOH) microscopy and negative culture for dermatophytes and ≤ 10% residual involvement of the target toenail)

  2. Mycological cure rate at Week 60 [ Time Frame: Baseline - Week 60 ]
    Defined as negative Potassium Hydroxide (KOH) microscopy and negative culture for dermatophytes of the target nail.


Other Outcome Measures:
  1. Negative culture rate for dermatophytes of the target nail at Week 60 [ Time Frame: Baseline - Week 60 ]
  2. Onychomycosis quality of life [ Time Frame: Baseline - Week 48, Week 60 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094468


Locations
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Sponsors and Collaborators
Polichem S.A.
Almirall, S.A.
Investigators
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Study Director: Maurizio Caserini, MD Polichem SA
More Information
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Responsible Party: Polichem S.A.
ClinicalTrials.gov Identifier: NCT03094468    
Other Study ID Numbers: PM1328
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Polichem S.A.:
terbinafine nail solution
nail fungal infection
topical antifungal drug
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
 Skin Diseases
Terbinafine
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action