A Study to See if Low Level Laser Light Can Help to Treat Toenail Fungus

NCT03066336 | Withdrawn FDA Device

• 1 other identifier: EC_LL_MYC_PS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Onychomycosis of Toenail

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Erchonia LunulaLaser

EXPERIMENTAL

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.

Device: Erchonia LunulaLaser

Interventions

Erchonia LunulaLaser DEVICE

Active Low Level 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:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (1)

University Of Miami Department of Dermatology

Miami, Florida, 33146, United States

Location

Study Officials

• Antonella Tosti, MD

  PRINCIPAL INVESTIGATOR

• Ted Rosen, MD

  unaffilliated

  PRINCIPAL INVESTIGATOR

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: February 23, 2017
• First Posted: February 28, 2017
• Study Start: April 10, 2017
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)