A Study to See if Low Level Laser Light Can Help to Treat Toenail Fungus
Primary Purpose
Onychomycosis of Toenail
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Erchonia LunulaLaser
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis of Toenail
Eligibility Criteria
Inclusion Criteria:
- Visual clinical presentation of onychomycosis in the target great toenail is distal subungual onychomycosis (DSO), visualized as a nail with normal surface texture and thickness but variable "bays" of white nail that extend from the distal nail tip proximally into the area of the nail bed
- Clinical involvement of onychomycosis in the target toenail is up to 60%
- Confirmation of the presence of fungal infection through a positive KOH stain finding and a positive fungal culture finding
- Identification through fungal culture of the growth of Trichophyton rubrum (T. rubrum) or other common dermatophyte or C. albicans or mixed dermatophyte/Candida infection. In the event of the KOH stain and the fungal culture provide conflicting results, i.e., one is positive and the other negative, resolution may be obtained by a second negative fungal culture finding from a nail clipping from the same nail
- 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
Exclusion Criteria:
- Visual clinical presentations of onychomycosis in the target great toenail that are inconsistent with the clinical presentation of distal subungual onychomycosis (DSO), in whole or in part (i.e. indicative of mixed etiology); specifically proximal subungual onychomycosis (PSO); superficial white onychomycosis (SWO); complete dystrophy; other nail changes.
- Identification through fungal culture of the growth of a rare fungal species (i.e. not Trichophyton rubrum (T. rubrum) or other common dermatophyte or C. albicans or mixed dermatophyte/Candida infection) or non-fungal organisms such as mold or bacteria
- 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)
- Infection involving lunula e.g., genetic nail disorders, primentary disorders
- Severe plantar (moccasin) tinea pedis
- Psoriasis of the skin and/or nails, lichen planus, or other medical conditions known to induce nail changes
- Onychogryphosis
- Trauma from ill-fitting shoes, running, or overly-aggressive nail care
- Previous toenail surgery
- Uncontrolled diabetes mellitus
- Peripheral vascular disease
- Recurrent cellulitis
- Lymphatic insufficiency
- Immune compromise (whether due to underlying medical disorders or immuno-suppressive treatments)
- Other compromised states of health
- Known photosensitivity disorder
- Use of oral antifungal drugs in the prior 6 months
- Use of topical treatment of the skin or nails within the prior 2 months
- Any abnormality of the toenail that could prevent a normal appearing nail from occurring if clearing of infection is achieved.
- Current trauma, open wound on or about the treatment area
- Deformity of the target toe/toenail secondary to fungal infection/onychomycosis due to prior injury, surgical procedures or another medical condition
- Pregnant 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.
Sites / Locations
- University Of Miami Department of Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Erchonia LunulaLaser
Arm Description
The Erchonia LunulaLaser 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.
Outcomes
Primary Outcome Measures
Percent (%) of toenails attaining mycologic cure at study endpoint
Mycologic cure is defined as both negative Potassium Hydroxide (KOH) and negative Fungal Culture results, or two serial negative Fungal Culture results.
Secondary Outcome Measures
Full Information
NCT ID
NCT03066336
First Posted
February 23, 2017
Last Updated
August 17, 2023
Sponsor
Erchonia Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03066336
Brief Title
A Study to See if Low Level Laser Light Can Help to Treat Toenail Fungus
Official Title
A Pilot Evaluation of the Effect of the Erchonia LunulaLaser for the Treatment of Toenail Onychomycosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty recruiting subjects
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erchonia Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether low level laser therapy (LLLT) using the Erchonia LunulaLaser device is effective in clearing toenails with onychomycosis.
Detailed Description
Nail onychomycosis, or fungus infection, is typically caused by a fungus called dermatophytes, but may also be caused by yeasts and molds. These microscopic organisms invade the skin through tiny invisible cuts or through a small separation between the nail and the nail bed. Under conditions of warmth and moisture, the fungi grow and spread. The infection begins as a white or yellow spot under the tip of the nail, and as it spreads deeper into the nail, causes unsightly and potentially painful nail discoloration, thickening and the development of crumbling edges. Onychomycosis occurs more commonly in toenails than in fingernails because toenails are often confined in a dark, warm, moist environment inside shoes where fungi can thrive. Toenail fungus affects approximately 23 million people in the US - about 10% of all adults.
Potential complications of onychomycosis include pain in the nails, permanent damage to the nails, development of other serious infections that can spread beyond the feet for individuals with a suppressed immune system due to medication, diabetes or other conditions, such as leukemia and AIDS.
Nail fungus can be difficult to treat, and repeated infections are common. Currently available treatments for onychomycosis include oral antifungal medications, antifungal lacquer, and topical medications, surgical nail removal and photodynamic therapy. There is no perfect cure for toenail fungus. Even the most effective oral medications are successful only about half of the time, and 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 to no risk of side effects. Laser therapy is applied to toenail onychomycosis by shining a laser light through the toenail into the tissue below. The laser light vaporizes the fungus while leaving the skin and surrounding healthy tissue unharmed.
Low level laser 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 (OM) 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 OM without the onset of any adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis of Toenail
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erchonia LunulaLaser
Arm Type
Experimental
Arm Description
The Erchonia LunulaLaser 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.
Intervention Type
Device
Intervention Name(s)
Erchonia LunulaLaser
Intervention Description
Active Low Level Laser Light Therapy
Primary Outcome Measure Information:
Title
Percent (%) of toenails attaining mycologic cure at study endpoint
Description
Mycologic cure is defined as both negative Potassium Hydroxide (KOH) and negative Fungal Culture results, or two serial negative Fungal Culture results.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Visual clinical presentation of onychomycosis in the target great toenail is distal subungual onychomycosis (DSO), visualized as a nail with normal surface texture and thickness but variable "bays" of white nail that extend from the distal nail tip proximally into the area of the nail bed
Clinical involvement of onychomycosis in the target toenail is up to 60%
Confirmation of the presence of fungal infection through a positive KOH stain finding and a positive fungal culture finding
Identification through fungal culture of the growth of Trichophyton rubrum (T. rubrum) or other common dermatophyte or C. albicans or mixed dermatophyte/Candida infection. In the event of the KOH stain and the fungal culture provide conflicting results, i.e., one is positive and the other negative, resolution may be obtained by a second negative fungal culture finding from a nail clipping from the same nail
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
Exclusion Criteria:
Visual clinical presentations of onychomycosis in the target great toenail that are inconsistent with the clinical presentation of distal subungual onychomycosis (DSO), in whole or in part (i.e. indicative of mixed etiology); specifically proximal subungual onychomycosis (PSO); superficial white onychomycosis (SWO); complete dystrophy; other nail changes.
Identification through fungal culture of the growth of a rare fungal species (i.e. not Trichophyton rubrum (T. rubrum) or other common dermatophyte or C. albicans or mixed dermatophyte/Candida infection) or non-fungal organisms such as mold or bacteria
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)
Infection involving lunula e.g., genetic nail disorders, primentary disorders
Severe plantar (moccasin) tinea pedis
Psoriasis of the skin and/or nails, lichen planus, or other medical conditions known to induce nail changes
Onychogryphosis
Trauma from ill-fitting shoes, running, or overly-aggressive nail care
Previous toenail surgery
Uncontrolled diabetes mellitus
Peripheral vascular disease
Recurrent cellulitis
Lymphatic insufficiency
Immune compromise (whether due to underlying medical disorders or immuno-suppressive treatments)
Other compromised states of health
Known photosensitivity disorder
Use of oral antifungal drugs in the prior 6 months
Use of topical treatment of the skin or nails within the prior 2 months
Any abnormality of the toenail that could prevent a normal appearing nail from occurring if clearing of infection is achieved.
Current trauma, open wound on or about the treatment area
Deformity of the target toe/toenail secondary to fungal infection/onychomycosis due to prior injury, surgical procedures or another medical condition
Pregnant 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonella Tosti, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ted Rosen, MD
Organizational Affiliation
unaffilliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Miami Department of Dermatology
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study to See if Low Level Laser Light Can Help to Treat Toenail Fungus
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