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Study of the Use of Low Level Laser Light Therapy to Treat Toenail Fungus

Primary Purpose

Onychomycosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Erchonia FX-405™ Laser
Sponsored by
Erchonia Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Onychomycosis present in at least one great toenail.
  • Disease involvement is at least 25%.
  • 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:

  • Spikes of disease extending to nail matrix.
  • Infection involving lunula, e.g., genetic nail disorders, primentary disorders.
  • 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).
  • 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 great toenail:
  • proximal subungual onychomycosis
  • white superficial onychomycosis
  • dermatophytoma or "yellow spike/streak"
  • exclusively lateral disease
  • confounding problems/abnormalities of the great toenail(s).
  • Any abnormality that could prevent a normal appearing nail if clearing of infection is achieved.
  • Inability for the toenail 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.
  • Use of topical antifungal agents in the past 1 month.
  • Prior surgical treatment of the affected great toe(s).
  • Cancer and/or treatment of any type of cancer within the last six months.
  • Peripheral vascular disease or peripheral circulatory impairment.
  • History of uncontrolled diabetes mellitus.
  • Known immunodeficiency.
  • Known sensitivity, or contraindication, to light therapy.
  • Pregnant, breast feeding, 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.

Sites / Locations

  • Arizona Institute of Footcare Physicians

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erchonia FX-405™ Laser

Arm Description

The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW

Outcomes

Primary Outcome Measures

Proportion of Toenails Attaining 25 Percent (%) or More Increase in Clear Nail
Millimeter (mm) of clear nail from the base of the lunula was measured 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 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there. An increase in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has improved and is positive for study success. A decrease in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has worsened and is negative for study success. Individual toenail success criteria was defined as 25 percent (%) or more increase in clear nail growth at 3 months post-procedure relative to baseline. Overall study success criteria was defined as 60% or more of treated toenails meeting the individual success criteria.

Secondary Outcome Measures

Change in Millimeter (mm) of Clear Nail Bed
Millimeter (mm) of clear nail from the base of the toenail lunula 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 3 months post-procedure administration. An increase in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has worsened and is negative for study success.
Change in Percent (%) of mm Clear Nail
Millimeter (mm) of clear nail from the base of the lunula was measured 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 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there.

Full Information

First Posted
February 14, 2012
Last Updated
November 7, 2015
Sponsor
Erchonia Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01534689
Brief Title
Study of the Use of Low Level Laser Light Therapy to Treat Toenail Fungus
Official Title
An Evaluation of the Effect of the Erchonia FX-405™ on Treating Toenail Onychomycosis Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erchonia Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether low level laser light is effective in the treatment of toenail fungus.
Detailed Description
An infection of toenail fungus, or onychomycosis, occurs when fungi infect one or more nails. As the nail fungus spreads deeper into the nail, it may cause nail discoloration, thickening and the development of crumbling edges, all of which can lead to an unsightly and potentially painful problem. Onychomycosis is difficult to treat, and infections recur easily. Toenail fungus affects approximately 23 million people in the US - about 10% of all adults. Currently available treatments for toenail fungus are lacking. Even the most effective oral medications are successful only about half of the time. 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 risk of side effects. Laser therapy is applied to toenail onychomycosis by shining a laser light through the toenail. The laser light vaporizes the fungus while leaving the skin and surrounding tissue unharmed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erchonia FX-405™ Laser
Arm Type
Experimental
Arm Description
The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW
Intervention Type
Device
Intervention Name(s)
Erchonia FX-405™ Laser
Intervention Description
The Erchonia FX-405™ dual diode laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
Primary Outcome Measure Information:
Title
Proportion of Toenails Attaining 25 Percent (%) or More Increase in Clear Nail
Description
Millimeter (mm) of clear nail from the base of the lunula was measured 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 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there. An increase in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has improved and is positive for study success. A decrease in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has worsened and is negative for study success. Individual toenail success criteria was defined as 25 percent (%) or more increase in clear nail growth at 3 months post-procedure relative to baseline. Overall study success criteria was defined as 60% or more of treated toenails meeting the individual success criteria.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Millimeter (mm) of Clear Nail Bed
Description
Millimeter (mm) of clear nail from the base of the toenail lunula 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 3 months post-procedure administration. An increase in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has worsened and is negative for study success.
Time Frame
12 weeks
Title
Change in Percent (%) of mm Clear Nail
Description
Millimeter (mm) of clear nail from the base of the lunula was measured 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 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Onychomycosis present in at least one great toenail. Disease involvement is at least 25%. 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: Spikes of disease extending to nail matrix. Infection involving lunula, e.g., genetic nail disorders, primentary disorders. 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). 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 great toenail: proximal subungual onychomycosis white superficial onychomycosis dermatophytoma or "yellow spike/streak" exclusively lateral disease confounding problems/abnormalities of the great toenail(s). Any abnormality that could prevent a normal appearing nail if clearing of infection is achieved. Inability for the toenail 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. Use of topical antifungal agents in the past 1 month. Prior surgical treatment of the affected great toe(s). Cancer and/or treatment of any type of cancer within the last six months. Peripheral vascular disease or peripheral circulatory impairment. History of uncontrolled diabetes mellitus. Known immunodeficiency. Known sensitivity, or contraindication, to light therapy. Pregnant, breast feeding, 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry Zang, DPM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Institute of Footcare Physicians
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85204
Country
United States

12. IPD Sharing Statement

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Study of the Use of Low Level Laser Light Therapy to Treat Toenail Fungus

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