Study of Erchonia Low Level Laser Light Therapy to Treat Toenail Fungus

NCT02242019 | Completed Results

• 1 other identifier: EC_TFRS_004
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether low level laser light therapy is effective in the treatment of toenail onychomycosis.

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (2)

• Number of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth

  Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 36 weeks post-procedure administration as evaluated relative to baseline. Overall study success criteria was defined as an 60% or more of treated toenails meeting the individual success criteria.

  Baseline and 36 Weeks

• Change in Millimeters (mm) of Clear Nail Bed

  Millimeter (mm) of clear nail from the base of the toenail was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. An increase in mm of clear nail between the two measurement points indicates that the toenail has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail has worsened and is negative for study success.

  Baseline and 36 Weeks

Secondary Outcomes (1)

• Change in Percent (%) of Onychomycosis Disease Involvement

  Baseline and 36 Weeks

Study Arms (1)

Erchonia LUNULA

EXPERIMENTAL

The Erchonia LUNULA 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 LUNULA

Interventions

Erchonia LUNULA DEVICE

The Erchonia LUNULA is administered to the infected toes for 12 minutes per treatment for 4 treatments, each treatment one week apart.

Erchonia LUNULA

Eligibility Criteria

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

You may qualify if:

• Onychomycosis present in at least one great toenail, identified as current bacterial/fungal infection classified by the investigator as onychomycosis, with the nail presenting positive on visual inspection for somewhat thickened nail plate with a cloudy appearance and some discoloration (white to yellow to brown).
• 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:

• Spikes of disease extending to nail matrix in the affected great toenail(s).
• Infection involving lunula of the affected toenail(s), e.g., genetic nail disorders, primentary disorders.
• Affected great toenail(s) has less than 2mm clear (unaffected) nail plate length beyond the proximal fold.
• Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the affected great toenail(s).
• Chronic plantar (moccasin) tinea pedis.
• History of current or past psoriasis of the skin and/or nails.
• Concurrent lichen planus.
• Onychogryphosis.
• Any of the following conditions of the affected great toenail(s) is present: proximal subungual onychomycosis; white superficial onychomycosis; dermatophytoma or "yellow spike/streak"; exclusively lateral disease
• Confounding problems/abnormalities of the great toenail(s).
• Any abnormality of the affected great toenail(s) that could prevent a normal appearing nail if clearing of infection is achieved.
• Inability for the affected great toenail(s) to become normal in the opinion of the investigator.
• History of multiple repeated failures with previous therapies for onychomycosis.
• Trauma to the affected great toenail(s).
• Use of oral antifungal agents in the past 6 months.

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (1)

Midleton Foot Clinical

Midleton, Co. Cork, Ireland

Location

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Consultant
• Organization: Regulatory Insight, Inc.

elvira@reginsight.com

615-712-9743

Study Officials

• Robert Sullivan, Podiatry

  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: September 12, 2014
• First Posted: September 16, 2014
• Study Start: February 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: May 17, 2016
• Results First Posted: August 10, 2015

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)