OnychomycosisNCT01534689
Study of the Use of Low Level Laser Light Therapy to Treat Toenail Fungus
A study testing Erchonia FX-405™ Laser in people with Onychomycosis, run by Erchonia Corporation at 1 site in United States.
Trial summary
The purpose of this study is to determine whether low level laser light is effective in the treatment of toenail fungus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Erchonia FX-405™ Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Onychomycosis present in at least one great toenail.
- Disease involvement is at least 25%.
- Subject is willing and able to refrain from employing other (non-study) treatments (traditional or alternative) for his or her toenail onychomycosis throughout study participation.
- Subject is willing and able to refrain from the use of nail cosmetics such as clear and/or colored nail lacquers throughout study participation.
Who cannot join
- Spikes of disease extending to nail matrix.
- Infection involving lunula, e.g., genetic nail disorders, primentary disorders.
- Less than 2mm clear (unaffected) nail plate length beyond the proximal fold.
- Presence of dermatophytoma (thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed).
- Chronic plantar (moccasin) tinea pedis.
- History of current or past psoriasis of the skin and/or nails.
Show all 31Show fewer
- Concurrent lichen planus.
- Onychogryphosis.
- Any of the following conditions of the great toenail:
- proximal subungual onychomycosis
- white superficial onychomycosis
- dermatophytoma or "yellow spike/streak"
- exclusively lateral disease
- confounding problems/abnormalities of the great toenail(s).
- Any abnormality that could prevent a normal appearing nail if clearing of infection is achieved.
- Inability for the toenail to become normal in the opinion of the investigator.
- History of multiple repeated failures with previous therapies for onychomycosis.
- Trauma to the affected great toenail(s).
- Use of oral antifungal agents in the past 6 months.
- Use of topical antifungal agents in the past 1 month.
- Prior surgical treatment of the affected great toe(s).
- Cancer and/or treatment of any type of cancer within the last six months.
- Peripheral vascular disease or peripheral circulatory impairment.
- History of uncontrolled diabetes mellitus.
- Known immunodeficiency.
- Known sensitivity, or contraindication, to light therapy.
- Pregnant, breast feeding, or planning pregnancy prior to the end of study participation.
- Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
- Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to follow study subject requirements and/or record the necessary study measurements.
- Involvement in litigation and/or receiving disability benefits related in any way to the parameters of the study.
- Participation in a clinical study or other type of research in the past 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Institute of Footcare Physicians
Mesa, Arizona, 85204
About this study
Official title: An Evaluation of the Effect of the Erchonia FX-405™ on Treating Toenail Onychomycosis Clinical Study
The purpose of this study is to determine whether low level laser light is effective in the treatment of toenail fungus.
Read the detailed description
An infection of toenail fungus, or onychomycosis, occurs when fungi infect one or more nails. As the nail fungus spreads deeper into the nail, it may cause nail discoloration, thickening and the development of crumbling edges, all of which can lead to an unsightly and potentially painful problem. Onychomycosis is difficult to treat, and infections recur easily. Toenail fungus affects approximately 23 million people in the US - about 10% of all adults. Currently available treatments for toenail fungus are lacking. Even the most effective oral medications are successful only about half of the time. Topical medications are successful less than 10% of the time. Recently, research has found laser therapy to show promise as a novel alternative treatment for toenail onychomycosis. Unlike medication-driven treatments for toenail fungus which can have many side effects including serious ones such as liver toxicity, laser therapy presents minimal risk of side effects. Laser therapy is applied to toenail onychomycosis by shining a laser light through the toenail. The laser light vaporizes the fungus while leaving the skin and surrounding tissue unharmed.
- Conditions
- Onychomycosis
- Being tested
- Erchonia FX-405™ Laser
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia FX-405™ LaserDevice
The Erchonia FX-405™ dual diode laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
| Study group | Role | What they receive |
|---|---|---|
| Erchonia FX-405™ Laser | Experimental | The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW Receives: Device: Erchonia FX-405™ Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Toenails Attaining 25 Percent (%) or More Increase in Clear Nail
Millimeter (mm) of clear nail from the base of the lunula was measured from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there. An increase in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has improved and is positive for study success. A decrease in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has worsened and is negative for study success.
Individual toenail success criteria was defined as 25 percent (%) or more increase in clear nail growth at 3 months post-procedure relative to baseline. Overall study success criteria was defined as 60% or more of treated toenails meeting the individual success criteria.
Measured: 12 weeks
Secondary outcomes (2)
Change in Millimeter (mm) of Clear Nail Bed
Millimeter (mm) of clear nail from the base of the toenail lunula was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. An increase in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has worsened and is negative for study success.
Measured: 12 weeks
Change in Percent (%) of mm Clear Nail
Millimeter (mm) of clear nail from the base of the lunula was measured from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startApr 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kerry Zang, DPM, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534689
- Sponsor's protocol ID
- EC_TF_001
- Status last verified
- Nov 2015
- First submitted
- 14 Feb 2012
- Last updated
- 11 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effect of the Erchonia FX-405™ on Treating Toenail Onychomycosis Clinical Study
- ClinicalTrials.gov ID
- NCT01534689
- Acronym / sponsor ID
- EC_TF_001
- Conditions
- Onychomycosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 17 Feb 2012 (estimated)
- Results
- Posted 11 Dec 2015
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 determine whether low level laser light is effective in the treatment of toenail fungus.
Detailed description
An infection of toenail fungus, or onychomycosis, occurs when fungi infect one or more nails. As the nail fungus spreads deeper into the nail, it may cause nail discoloration, thickening and the development of crumbling edges, all of which can lead to an unsightly and potentially painful problem. Onychomycosis is difficult to treat, and infections recur easily. Toenail fungus affects approximately 23 million people in the US - about 10% of all adults. Currently available treatments for toenail fungus are lacking. Even the most effective oral medications are successful only about half of the time. Topical medications are successful less than 10% of the time. Recently, research has found laser therapy to show promise as a novel alternative treatment for toenail onychomycosis. Unlike medication-driven treatments for toenail fungus which can have many side effects including serious ones such as liver toxicity, laser therapy presents minimal risk of side effects. Laser therapy is applied to toenail onychomycosis by shining a laser light through the toenail. The laser light vaporizes the fungus while leaving the skin and surrounding tissue unharmed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erchonia FX-405™ Laser | Experimental | Device: Erchonia FX-405™ LaserThe Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Onychomycosis present in at least one great toenail.
- Disease involvement is at least 25%.
- Subject is willing and able to refrain from employing other (non-study) treatments (traditional or alternative) for his or her toenail onychomycosis throughout study participation.
- Subject is willing and able to refrain from the use of nail cosmetics such as clear and/or colored nail lacquers throughout study participation.
Key exclusion criteria (31 listed)
- Spikes of disease extending to nail matrix.
- Infection involving lunula, e.g., genetic nail disorders, primentary disorders.
- Less than 2mm clear (unaffected) nail plate length beyond the proximal fold.
- Presence of dermatophytoma (thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed).
- Chronic plantar (moccasin) tinea pedis.
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 |
|---|---|---|
| Erchonia FX-405™ LaserThe Erchonia FX-405™ dual diode laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time. | Device | Erchonia FX-405™ Laser |
Primary outcome
Proportion of Toenails Attaining 25 Percent (%) or More Increase in Clear Nail
Time frame: 12 weeks
Millimeter (mm) of clear nail from the base of the lunula was measured from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there. An increase in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has improved and is positive for study success. A decrease in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has worsened and is negative for study success. Individual toenail success criteria was defined as 25 percent (%) or more increase in clear nail growth at 3 months post-procedure relative to baseline. Overall study success criteria was defined as 60% or more of treated toenails meeting the individual success criteria.
2 secondary outcomes
Change in Millimeter (mm) of Clear Nail Bed
Time frame: 12 weeks
Change in Percent (%) of mm Clear Nail
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Onychomycosis
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In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
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Systemic Antifungal Plus Q-Switched Nd:YAG Laser for Onychomycosis
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URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
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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.
Kerry Zang, DPM principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia FX-405™ Laser in people with Onychomycosis, run by Erchonia Corporation at 1 site 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 4 inclusion and 31 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 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 11 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Toenails Attaining 25 Percent (%) or More Increase in Clear Nail (time frame: 12 weeks). 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 11 Dec 2015.