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

NCT06006455 | Terminated Results FDA Device

• 1 other identifier: R-TOT
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Onychomycosis of Toenail

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Toenails Attaining Complete Cure

  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)

  12 months

Secondary Outcomes (1)

• Mycologic Cure

  14 months

Study Arms (1)

Erchonia LunulaLaser

EXPERIMENTAL

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

Interventions

Erchonia LunulaLaser DEVICE

405nm violet and 635nm red laser light therapy.

Erchonia LunulaLaser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (1)

Blemish Clinic

Edenfield, Cheshire, BL00JN, United Kingdom

Location

Results Point of Contact

• Title: Clinical Affairs Manager
• Organization: Erchonia Corporation

tsammons@erchonia.com

8882420571

Study Officials

• Robin Stones, MB.ChB

  Blemish Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: June 15, 2020
• Primary Completion: July 16, 2024
• Study Completion: September 10, 2024
• Last Updated: August 1, 2025
• Results First Posted: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)