Status:
COMPLETED
Study of Erchonia Low Level Laser Light Therapy to Treat Toenail Fungus
Lead Sponsor:
Erchonia Corporation
Conditions:
Onychomycosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether low level laser light therapy is effective in the treatment of toenail onychomycosis.
Detailed Description
An infection of toenail fungus, or onychomycosis, typically occurs when fungi (most commonly dermatophytes) infect the nail, but may also be caused by yeasts and molds. The nail fungal infection usual...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Use of topical antifungal agents in the past 1 month.
- Prior surgical treatment of the affected great toe(s).
- Subject is unwilling or unable to refrain from employing other (non-study) treatments (traditional and alternative) for his or her toenail onychomycosis throughout study participation.
- Subject is unwilling or unable to refrain from the use of nail cosmetics such as clear and/or colored nail lacquers until the end of study participation.
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT02242019
Start Date
February 1 2013
End Date
February 1 2014
Last Update
May 17 2016
Active Locations (1)
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1
Midleton Foot Clinical
Midleton, Co. Cork, Ireland