N/A
N=54
A Retrospective Analysis of the Effects of Low Level Laser Therapy on Toenail Onychomycosis
Onychomycosis
Bottom Line
View on ClinicalTrials.gov: NCT02588599 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Percent (%) of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth — 67 Percent of Toenails
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Erchonia LUNULA (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Erchonia Corporation
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent (%) of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth |
67 | — |
| SECONDARY Change in Millimeters (mm) of Clear Nail Bed |
5.18 | <0.0001 sig |
Summary
The purpose of this study is to determine whether low level laser therapy (LLLT) using the Erchonia LUNULA device is effective in increasing clear nail in toenails with onychomycosis.
Eligibility Criteria
Inclusion Criteria
- Great toenail presents with clearly visually identifiable and photographically documentable onychomycosis of the great toenail, or no visible onychomycosis (1 great toenail)
- Onychomycosis has been identified as due to 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)
- Onychomycosis etiology has been confirmed through positive fungal potassium hydroxide preparation (KOH) testing results
Exclusion Criteria
- Spikes of disease extending to nail matrix in the great toenail
- Infection involving lunula of the great toenail, e.g. genetic nail disorders, primentary disorders
- Great toenail has less than 2mm clear (unaffected) nail plate length beyond the proximal fold
- Dermatophytoma or "yellow spike/streak" (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the great toenail
- Onychogryphosis
- Proximal subungual onychomycosis
- White superficial onychomycosis
Data sourced from ClinicalTrials.gov (NCT02588599). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.