Suspended
Noveon Laser Treatment of Onychomycosis: A Device Performance Clinical Study
What is being tested
light therapy
Device
Who is being recruted
Bacterial Infections and Mycoses+7
+ Dermatomycoses
+ Infections
From 18 to 70 Years
+3 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 2
Interventional
Study Start: May 2008
Summary
Principal SponsorNomir Medical Technologies
Study ContactMary E OsterMore contacts
Last updated: January 27, 2026Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2008
Actual date on which the first participant was enrolled.This study is a one year study which includes four treatment sessions of light therapy looking for clinical and mycological improvement.
Official TitleNoveon Laser Treatment of Onychomycosis: A Device Performance Clinical Study
Principal SponsorNomir Medical Technologies
Study ContactMary E OsterMore contacts
Last updated: January 27, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Bacterial Infections and MycosesDermatomycosesInfectionsMycosesNail DiseasesSkin DiseasesSkin Diseases, InfectiousTineaOnychomycosisSkin and Connective Tissue Diseases
Criteria
2 inclusion criteria required to participate
toe nail fungus, not infolving lunula
between ages 18-70 years old
1 exclusion criteria prevent from participating
not on systemic anti-fungal medications
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalLight therapy
Group II
Sham6 minute "session" given with machine "off"
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
SuspendedOne Study Center