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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03066336
Other study ID # EC_LL_MYC_PS
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 10, 2017
Est. completion date November 1, 2021

Study information

Verified date August 2023
Source Erchonia Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 1, 2021
Est. primary completion date November 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Erchonia LunulaLaser
Active Low Level Laser Light Therapy

Locations

Country Name City State
United States University Of Miami Department of Dermatology Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
Erchonia Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 months
See also
  Status Clinical Trial Phase
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Active, not recruiting NCT05110638 - Safety and Tolerability Study of SKX-16 in Subjects With Moderate to Severe Distal Subungual Onychomycosis Phase 1
Completed NCT05260450 - Laser Treatment of Toenail Onychomycosis With a 1064 nm Nd:YAG-laser N/A
Completed NCT03382717 - Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis N/A
Not yet recruiting NCT06417983 - Topical Application of Essential Oils to Treat Onchomycosis
Withdrawn NCT03094468 - Study to Evaluate the Efficacy and Safety of P-3058 Nail Solution in the Treatment of Onychomycosis Phase 3
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Recruiting NCT06006455 - Effect of the Erchonia® LunulaLaserâ„¢ for the Treatment of Toenail Onychomycosis N/A
Not yet recruiting NCT03098342 - Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment N/A
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Active, not recruiting NCT05135910 - To Evaluate Hallux Terbinafine Subungual Gel (HSG) in the Treatment of Onychomycosis Phase 2
Active, not recruiting NCT05139888 - Light Therapy for Onychomycosis Study N/A
Completed NCT04961684 - Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis N/A
Completed NCT03141840 - Clinical Trial of Topical ABL01 Treatment of Onychomycosis N/A
Recruiting NCT04084782 - An Internet Mediated Research Study to Assess the Quality of Life of Consumers With Self-reported Fungal Nail Infection (Onychomycosis) During Treatment With Scholl Fungal Nail.