Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Toenail Onychomycosis
NCT ID: NCT02549001
Last Updated: 2018-09-26
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
953 participants
INTERVENTIONAL
2015-08-20
2018-09-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate the Efficacy and Safety of P-3058 Nail Solution in the Treatment of Onychomycosis
NCT03094468
A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2)(COMPLETED)
NCT00491764
Clinical Trial on Onychomycosis With P-3058 Nail Solution in Pediatric Population
NCT02547701
Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
NCT01270971
Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis
NCT00459537
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
P-3058 10%
P-3058 10%
P-3058 10%
vehicle of P-3058 10%
vehicle of P-3058 10%
vehicle of P-3058 10%
amorolfine 5%
Loceryl®
amorolfine 5%
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
P-3058 10%
vehicle of P-3058 10%
amorolfine 5%
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Polichem S.A.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maurizio Caserini, MD
Role: STUDY_DIRECTOR
Polichem S.A.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Polichem Investigative Site
Multiple Locations, , Belgium
Polichem Investigative Site
Multiple Locations, , Bulgaria
Polichem Investigative Site
Multiple Locations, , Czechia
Polichem Investigative Site
Multiple Locations, , Germany
Polichem Investigative Site
Multiple Locations, , Greece
Polichem Investigative Site
Multiple Locations, , Hungary
Polichem Investigative Site
Various Cities in Iceland, , Iceland
Polichem Investigative Site
Multiple Locations, , Latvia
Polichem Investigative Site
Multiple Locations, , Lithuania
Polichem Investigative Site
Multiple Locations, , Poland
Polichem Investigative Site
Multiple Locations, , Russia
Polichem Investigative Site
Multiple Locations, , Slovakia
Polichem Investigative Site
Multiple Locations, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-000561-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PM1331
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.