Study of Erchonia Low Level Laser Light Therapy to Treat Toenail Fungus
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|ClinicalTrials.gov Identifier: NCT02242019|
Recruitment Status : Completed
First Posted : September 16, 2014
Results First Posted : August 10, 2015
Last Update Posted : May 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Onychomycosis||Device: Erchonia LUNULA||Not Applicable|
An infection of toenail fungus, or onychomycosis, typically occurs when fungi (most commonly dermatophytes) infect the nail, but may also be caused by yeasts and molds. The nail fungal infection usually begins as a white or yellow spot under the tip of the toenail and then spreads deeper into the nail causing discoloration, thickening and the development of crumbling edges to the nail which can be unsightly and painful and may produce serious physical and occupational limitations. Onychomycosis can also have a detrimental effect on an individual's quality of life, affecting their psychosocial and emotional wellbeing.
Onychomycosis can be difficult to treat, and infections recur easily. Toenail fungus affects approximately 23 million adults (about 10%) in the United States. It is more common among older adults and tends to affect men more than women. Potential complications of onychomycosis include pain, permanent damage to the nails and serious infections that can spread beyond the feet.
Currently available treatments for onychomycosis include oral antifungal medications (Lamisil, Sporanox); antifungal nail polish (Penlac); topical over-the-counter antifungal creams; photodynamic therapy and in more severe cases, surgery to remove the nail. However, there is no perfect cure for toenail fungus. Even the most effective oral medications are only successful about half of the time, and topical medications are successful less than 10% of the time. In addition, clearance of the infection and growth of new clear nail can be slow, and the rate of recurrence of infection is high. Antifungal drugs may also cause side effects ranging from skin rashes to liver damage.
Therefore, the need for a more effective and lasting cure is evident. Recently, research has found laser therapy to show promise as a novel alternative treatment for toenail onychomycosis. Unlike medication-driven treatments, 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.
Low level laser light therapy operates under the principle of photochemistry with a photoacceptor molecule absorbing the emitted photons and inducing a biological cascade. Like our eukaryotic cell, fungi contain the highly complex organelle the mitochondria, which is responsible for the manufacturing of the energy molecule Adenosine triphosphate (ATP). Within the inner mitochondrial membrane is cytochrome c oxidase, an identified photoacceptor molecule. It is believed that laser therapy could perhaps provide a means to photo-destroy the fungi responsible for onychomycosis by inducing the release of highly reactive superoxides. Moreover, laser therapy has been shown to promote superoxide dismutase (SOD), a process responsible for the destruction of foreign invaders. Extracellular release of low levels of mediators associated with SOD can increase the expression of chemokines, cytokines, and endothelial leukocyte adhesion molecules, amplifying the cascade that elicits the inflammatory response. The physiologic function of hydrogen peroxide, superoxide anion, and hydroxyl free radical is to destroy phagocytosed microbes. By enhancing the natural processes of the immune system and impacting the structural integrity of the fungi strain, it is believed that laser therapy may provide a means for clinicians to effectively treat onychomycosis without the onset of any adverse events.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||109 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Evaluation of the Effect of the Erchonia LUNULA on Treating Toenail Onychomycosis|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Experimental: Erchonia LUNULA
The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
Device: Erchonia LUNULA
The Erchonia LUNULA is administered to the infected toes for 12 minutes per treatment for 4 treatments, each treatment one week apart.
- Number of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth [ Time Frame: Baseline and 36 Weeks ]Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 36 weeks post-procedure administration as evaluated relative to baseline. Overall study success criteria was defined as an 60% or more of treated toenails meeting the individual success criteria.
- Change in Millimeters (mm) of Clear Nail Bed [ Time Frame: Baseline and 36 Weeks ]Millimeter (mm) of clear nail from the base of the toenail 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 36 weeks after the end of the procedure administration phase. An increase in mm of clear nail between the two measurement points indicates that the toenail has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail has worsened and is negative for study success.
- Change in Percent (%) of Onychomycosis Disease Involvement [ Time Frame: Baseline and 36 Weeks ]The percent (%) of the toenail that had onychomycosis disease involvement was determined. Change in the % of toenail onychomycosis disease involvement was calculated as the difference in the % of toenail onychomycosis disease involvement from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. A decrease in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has decreased and is positive for study success. An increase in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has increased and is negative for study success.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02242019
|Midleton Foot Clinical|
|Midleton, Co. Cork, Ireland|
|Principal Investigator:||Robert Sullivan, Podiatry|