Study to Evaluate the Efficacy and Safety of P-3058 Nail Solution in the Treatment of Onychomycosis
NCT ID: NCT03094468
Last Updated: 2018-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2017-05-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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P-3058
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.
Vehicle
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
ALL
No
Sponsors
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Almirall, S.A.
INDUSTRY
Polichem S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Maurizio Caserini, MD
Role: STUDY_DIRECTOR
Polichem SA
Locations
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Polichem Investigation Site no 45
North Hollywood, California, United States
Polichem Investigation Site no 5
Oceanside, California, United States
Polichem Investigation Site no 39
San Diego, California, United States
Polichem Investigation Site no 2
Hialeah, Florida, United States
Polichem Investigation Site no 23
Jacksonville, Florida, United States
Polichem Investigation Site no 22
Miami, Florida, United States
Polichem Investigation Site no 52
Louisville, Kentucky, United States
Polichem Investigation Site no 41
Portsmouth, New Hampshire, United States
Polichem Investigation site no 1
New York, New York, United States
Polichem Investigation Site no 44
Cincinnati, Ohio, United States
Polichem Investigation Site no 40
Norman, Oklahoma, United States
Polichem Investigation Site no 14
Oklahoma City, Oklahoma, United States
Polichem Investigation Site no 10
Austin, Texas, United States
Polichem Investigation Site no 11
Dallas, Texas, United States
Polichem Investigation Site no 43
Dallas, Texas, United States
Polichem Investigation Site no 6
Fort Worth, Texas, United States
Polichem Investigation Site no 12
Houston, Texas, United States
Polichem Investigation Site no 4
Houston, Texas, United States
Polichem Investigation Site no 42
Pflugerville, Texas, United States
Polichem Investigation Site no 53
San Antonio, Texas, United States
Polichem Investigation Site no 54
San Antonio, Texas, United States
Polichem Investigation site no 3
Calgary, Alberta, Canada
Polichem Investigation Site no 8
Edmonton, Alberta, Canada
Polichem Investigation Site no 13
Mississauga, Ontario, Canada
Polichem Investigation Site no 9
Richmond Hill, Ontario, Canada
Polichem Investigation Site no 7
Toronto, Ontario, Canada
Countries
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Other Identifiers
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PM1328
Identifier Type: -
Identifier Source: org_study_id
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