An interventional study of Erchonia FX-405™ Laser in Onychomycosis, sponsored by Erchonia Corporation. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-11.
Sponsored by Erchonia Corporation · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether low level laser light is effective in the treatment of toenail fungus.
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.
147 studies on the registry are indexed under Onychomycosis; 13 are open to participants now.
This study's enrollment of 105 is above the median of 56 across 134 interventional studies indexed under Onychomycosis.
Browse Onychomycosis studies →Erchonia Corporation is the lead sponsor of 48 studies on the registry; 2 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.
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Exclusion Criteria:
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
Device: Erchonia FX-405™ Laser
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.
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.
Time frame: 12 weeks
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.
Time frame: 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.
Time frame: 12 weeks
| Milestone | Erchonia FX-405™ Laser |
|---|---|
| Started | 105 |
| Completed | 105 |
| Not completed | 0 |
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.
| percentage of toenails | Erchonia FX-405™ Laser |
|---|---|
| Proportion of Toenails Attaining 25 Percent (%) or More Increase in Clear Nail | 65 |
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.
| millilmeters | Erchonia FX-405™ Laser |
|---|---|
| Change in Millimeter (mm) of Clear Nail Bed | 4.99 ± 2.24 |
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.
| percentage of change in mm clear nail | Erchonia FX-405™ Laser |
|---|---|
| Change in Percent (%) of mm Clear Nail | 30.36 ± 19.43 |
Collected over 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Erchonia FX-405™ Laser | — | 0/105 (0%) | 0/105 (0%) |
| Age, Continuous(years) | Erchonia FX-405™ Laser |
|---|---|
| Mean | 59.5 ± 12.85 |
| Sex: Female, Male(Participants) | Erchonia FX-405™ Laser |
|---|---|
| Female | 64 |
| Male | 41 |
| Race (NIH/OMB)(Participants) | Erchonia FX-405™ Laser |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 102 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Erchonia FX-405™ Laser |
|---|---|
| United States | 105 |
| Percent (%) Toenail Onychomycosis Disease Involvement(percent of toenail) | Erchonia FX-405™ Laser |
|---|---|
| Mean | 57.39 ± 21.86 |
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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