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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03094468
Recruitment Status : Withdrawn (Project development priorities changed)
First Posted : March 29, 2017
Last Update Posted : January 10, 2018
Almirall, S.A.
Information provided by (Responsible Party):
Polichem S.A.

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.

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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

Resource links provided by the National Library of Medicine

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.

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.

Information from the National Library of Medicine

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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

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.

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 identifier (NCT number): NCT03094468

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

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Responsible Party: Polichem S.A. Identifier: NCT03094468     History of Changes
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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Skin Diseases, Infectious
Nail Diseases
Skin Diseases
Pharmaceutical Solutions
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action