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

NCT ID: NCT01534689

Last Updated: 2015-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-04-30

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.

Conditions

Onychomycosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Erchonia FX-405™ Laser

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

Group Type: EXPERIMENTAL

Erchonia FX-405™ Laser

Intervention Type: DEVICE

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.

Interventions

Erchonia FX-405™ Laser

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erchonia Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kerry Zang, DPM

Role: PRINCIPAL_INVESTIGATOR

Locations

Arizona Institute of Footcare Physicians

Mesa, Arizona, United States

Countries

United States

Other Identifiers

EC_TF_001

Identifier Type: -

Identifier Source: org_study_id