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Effect of the Erchonia® LunulaLaser™ for the Treatment of Toenail Onychomycosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06006455
Recruitment Status : Recruiting
First Posted : August 23, 2023
Last Update Posted : May 10, 2024
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation

Study Description
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Brief Summary:
The purpose of this clinical study is to demonstrate the efficacy of the Erchonia LunulaLaser™, for the treatment of onychomycosis of the toenail.

Condition or disease Intervention/treatment Phase
Onychomycosis of Toenail Device: Erchonia LunulaLaser Not Applicable

Detailed Description:
This active test treatment group only study will evaluate the effectiveness of the Erchonia LunulaLaser™ manufactured by Erchonia Corporation (the Sponsor) for the treatment of onychomycosis of the toenail.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Evaluation of the Effect of the Erchonia® LunulaLaser™ for the Treatment of Toenail Onychomycosis
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : February 1, 2025
Estimated Study Completion Date : March 1, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Erchonia LunulaLaser
The Erchonia LunulaLaser emits red light (635 nm) and violet light (405 nm) to the affected toenail for 12 minutes per treatment. The treatment phase involves an initial weekly treatment administration phase, 1 treatment a week for 4 weeks, followed by an every two-month maintenance treatment administration phase, months 3, 5, 7, 9, and 11.
 Device: Erchonia LunulaLaser
405nm violet and 635nm red laser light therapy.


Outcome Measures
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Primary Outcome Measures :
  1. Percent (%) of toenails attaining Complete Cure at study endpoint [ Time Frame: 12 months ]

    Complete Cure criteria is defined as a subject/toenail satisfying both the 'Clinical Cure' and the 'Mycological Cure' criteria in order to be considered a study responder, defined as follows:

    (i) Clinical Cure: Measurement of clear nail increase as the following:

    • at least 12 mm increase in clear nail of the great toenail, with evidence of distal growth of the affected area, 12 months after the first treatment; or
    • complete clearance 12 months after the first treatment if less than 12 mm distal nail was involved prior to treatment.

    The response should be progressive in at least 2 sequential timepoints that are at least 3 months apart, with projected increase of at least 1 mm per month.

    (ii) Mycologic Cure: both negative KOH and negative Fungal Culture results (or two serial negative Fungal Culture results)



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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 between 20%-50%
  • 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
  • Male or female
  • 18 years of age or older

Exclusion Criteria:

  • Lack of confirmation of the presence of fungal infection through a negative KOH stain finding and/or a negative fungal culture finding

  • 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 visual clinical presentations consistent with one or more of the following:

    • Proximal subungual onychomycosis (PSO): visualized as a white discoloration below the nail plate at the base of the nail, near the lunula. The distal nail retains normal appearance and texture. PSO involves infection near the matrix, deep to the nail. It may be associated with trauma to the nail or to immune compromise
    • Superficial white onychomycosis (SWO): visualized by the appearance of a white coating on the nail surface that can be eliminated by filing or buffing the surface of the affected portion of the nail
    • Complete dystrophy: Nails which are 100% dystrophic are manifested by yellowing and thickening of the entire nail unit
    • Other nail changes: Nails that visually present with changes that appear as parallel lines, small pinpoint depressions, brown spots, black or brown linear streaks, complete yellowing of all nails without textural change, green debris below the nail, or notches in the nail margin
  • 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 immunosuppressive 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.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT06006455


Contacts
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Contact: Travis Sammons 8882420571 ext 501 tsammons@erchonia.com

Locations
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United Kingdom
Blemish Clinic Recruiting
Edenfield, Cheshire, United Kingdom, BL00JN
Contact: Jan Birch    +44 1706 822689    jan@alamedtech.co.uk   
Principal Investigator: Robin Stones, MB.ChB         
Sponsors and Collaborators
Erchonia Corporation
Investigators
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Principal Investigator: Robin Stones, MB.ChB Blemish Clinic
More Information
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Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT06006455    
Other Study ID Numbers: R-TOT
First Posted: August 23, 2023    Key Record Dates
Last Update Posted: May 10, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Mycoses
Bacterial Infections and Mycoses
 Infections
Skin Diseases, Infectious
Nail Diseases
Skin Diseases