OnychomycosisNCT01452490
Diode Laser Treatment of Onychomycosis
A study testing Diode Laser Treatment in people with Onychomycosis, run by ConBio, a Cynosure Company at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the V-Raser diode laser system with investigational Nail Fungus Handpiece in the treatment of onychomycosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Diode Laser Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2011to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed subungual onychomycosis in a great toe that does not extend to the eponychium
- Fitzpatrick Skin Type I-IV
- Written and verbal informed consent
- Able to comply with study instructions and to return to the clinic for required visits
- Agrees to refrain from other active topical, laser or light-based treatment to the great toes
- Agrees to the use of Naftin Gel between the toes to prevent/control tinea pedis
Who cannot join
- Pregnancy, breastfeeding or planning to become pregnant
- History of cutaneous photosensitivity, porphyria and hypersensitivity to porphyrins or photodermatoses
- Any skin pathology or condition that could interfere with the evaluation or that requires the use of interfering topical or systemic therapy
- Coagulation disorder or current use of anti-coagulation medication (including aspirin use of greater than 81 mg per day)
- Any condition which, in the investigator's opinion, would make it unsafe for the subject to participate
- Enrolled in an investigational drug or device trial, or has been treated with an investigational device or received an investigational drug within 30 days
Show all 11Show fewer
- Oral Lamisil within 1 year, Sporanox or over-the-counter topicals within 1 month, or other prescription anti-fungal medications or topicals within 6 months
- Evidence of diabetic neuropathy or peripheral vascular disease related to diabetes, or a loss of protective sensation in the affected foot
- Psoriasis, lichen planus, infection involving the lunula, prior surgical treatment of the affected great toe within 1 year, or a history of trauma to the affected great toe
- Immunocompromised status, or with existing (or history of) cancer/skin malignancy
- Distal nail thickness of greater than 2mm in the affected great toenail
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Shoreline Foot and Ankle Center
New London, Connecticut, 06320
Shoreline Foot and Ankle Center
Westbrook, Connecticut, 06498
About this study
Official title: Study of the V-Raser Diode Laser System in the Treatment of Onychomycosis
The purpose of this study is to evaluate the V-Raser diode laser system with investigational Nail Fungus Handpiece in the treatment of onychomycosis.
- Conditions
- Onychomycosis
- Being tested
- Diode Laser Treatment
- Keywords
- Onychomycosis, Toenail Fungus
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode Laser TreatmentDevice
Also called V-Raser
Laser treatment once every 6 weeks, for a total of 4 treatment sessions
| Study group | Role | What they receive |
|---|---|---|
| Diode Laser Treatment | Experimental | Not described Receives: Device: Diode Laser Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Clear Nail Growth from Baseline in mm or as measurement of total area of involvement
Amount of lesion-free toenail growth (mm or total area of involvement) from Baseline, as judged by computer software analysis of photos.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Even though this study has recruited more than 10 participants, it is a feasibility study, designed to test the prototype rather than measuring health outcomes. It is to confirm the operating specifications before beginning a full clinical trial.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConBio, a Cynosure Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Darren Courtright, DPM, Principal investigator, Shoreline Foot and Ankle Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452490
- Sponsor's protocol ID
- D4-11-F
- Status last verified
- Oct 2020
- First submitted
- 11 Oct 2011
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the V-Raser Diode Laser System in the Treatment of Onychomycosis
- ClinicalTrials.gov ID
- NCT01452490
- Acronym / sponsor ID
- D4-11-F
- Conditions
- Onychomycosis
- Keywords
- Onychomycosis, Toenail Fungus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- ConBio, a Cynosure CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the V-Raser diode laser system with investigational Nail Fungus Handpiece in the treatment of onychomycosis.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Even though this study has recruited more than 10 participants, it is a feasibility study, designed to test the prototype rather than measuring health outcomes. It is to confirm the operating specifications before beginning a full clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Diode Laser Treatment | Experimental | Device: Diode Laser Treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed subungual onychomycosis in a great toe that does not extend to the eponychium
- Fitzpatrick Skin Type I-IV
- Written and verbal informed consent
- Able to comply with study instructions and to return to the clinic for required visits
- Agrees to refrain from other active topical, laser or light-based treatment to the great toes
Key exclusion criteria (11 listed)
- Pregnancy, breastfeeding or planning to become pregnant
- History of cutaneous photosensitivity, porphyria and hypersensitivity to porphyrins or photodermatoses
- Any skin pathology or condition that could interfere with the evaluation or that requires the use of interfering topical or systemic therapy
- Coagulation disorder or current use of anti-coagulation medication (including aspirin use of greater than 81 mg per day)
- Any condition which, in the investigator's opinion, would make it unsafe for the subject to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diode Laser TreatmentAlso: V-RaserLaser treatment once every 6 weeks, for a total of 4 treatment sessions | Device | Diode Laser Treatment |
Primary outcome
Amount of Clear Nail Growth from Baseline in mm or as measurement of total area of involvement
Time frame: 12 months
Amount of lesion-free toenail growth (mm or total area of involvement) from Baseline, as judged by computer software analysis of photos.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
Related trials for Onychomycosis
RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
Not yet recruiting
Systemic Antifungal Plus Q-Switched Nd:YAG Laser for Onychomycosis
Onychomycosis
Active, not recruitingPhase 1
Photodynamic Therapy For Onychomycosis
Onychomycosis of Toenail
Recruiting
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
Onychomycosis of Toenail
Active, not recruiting
Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
Onychomycosis of Toenails, Onychomycosis of Fingernail
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Courtright, DPM principal investigator
Shoreline Foot and Ankle Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diode Laser Treatment in people with Onychomycosis, run by ConBio, a Cynosure Company at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Clear Nail Growth from Baseline in mm or as measurement of total area of involvement (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.