Study of the Use of Low Level Laser Light Therapy to Treat Toenail Fungus
Completed · Not applicable
Conditions studied: Onychomycosis
In brief
The purpose of this study is to determine whether low level laser light is effective in the treatment of toenail fungus.
Key facts
- Study ID
- NCT01534689
- Run by
- Erchonia Corporation
- People needed
- 105
- Starts
- 2011-04-01
- Expected to finish
- 2012-04-01
- Last updated by the study team
- 2015-12-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Arizona Institute of Footcare Physicians — Mesa, Arizona, United States
Full record on ClinicalTrials.gov
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