Prospective Efficacy and Safety Evaluation of Laser Treatments With Real-Time Temperature Feedback for Fungal Onychomycosis
November 2013 | Volume 12 | Issue 11 | Original Article | 1237 | Copyright © November 2013
Jill Waibel MD, Adam Jared Wulkan MD, and Ashley Rudnick
Miami Dermatology and Laser Institute, Miami, FL
BACKGROUND and OBJECTIVES: Onychomycosis affects five percent of the worldwide population. Onychomycosis is a therapeutic challenge.
Current therapies on the market are either ineffective or require patient monitoring. Laser and light technologies are being investigated
as a possible treatment option for onychomycosis. The proposed mechanism of action is unknown. All infectious agents may be
killed by heat (except prions). One possible theory is the photothermal effect from water absorbing lasers creates bulk heating in the
nail plate to kill fungal hyphae. Laser technology may be a promising new treatment option for onychomycosis. This is a prospective trial
with real-time temperature feedback to evaluate efficacy and safety of laser therapy for onychomycosis.
METHODS: Twenty-one patients with PAS or culture proven fungal onychomycosis were prospectively treated with laser until target
temperature of 46 - 48 degrees Celsius was achieved using real-time infrared temperature feedback. The laser and light therapies used
were 1319nm, 1064nm and BroadBand Light. Exclusion criteria included mixed infection and no other prior therapeutic interventions.
Subjects received four treatment sessions one week apart. Assessments included PAS & cultures at one, three and six months post
treatment. Patients also were asked a pain score from 1-10 during treatment.
RESULTS: Patients tolerated the procedures well with high satisfaction. Average treatment time was 10 minutes. No adverse events
were noted. Patients reported mild-moderate transient discomfort during treatment. Six-month culture results revealed 20/21 negative
for fungal organisms.
CONCLUSION: Laser therapy offers a safe and effective new option for onychomycosis. This may be the optimal therapy for a large market
that needs alternative or adjunct to current therapies. Laser is quick, painless therapy that does not require any oral medications or
blood test for monitoring. Additional larger scientific studies are needed to confirm our pilot study results. J Drugs Dermatol.
Onychomycosis refers to a fungal infection affecting the
nail plate or the nail bed of the toenails or fingernails.1 It is generally caused by dermatophytes and less frequently
by non-dermatophyte molds and yeasts.2 The term
dermatophyte refers specifically to fungi related to the genera Trichophyton, Epidermophyton, and Microsporidium, which
cause an infection of the skin, hair and nails due to their ability
to obtain nutrients from keratinized material.3 They are usually
restricted to the non-living cornified layer of the epidermis because
of their inability to penetrate viable immunocompetent
tissue. However, any component of the nail may be involved,
including the nail matrix, nail bed or nail plate.
Onychomycosis is a medical condition with aesthetic side
effects for many patients.4 While it is not a life threatening condition,
it may lead to serious morbidity, including secondary
bacterial infections.2,5 Furthermore, onychomycosis can cause
pain, discomfort and may produce serious physical and occupational
limitations. The psychosocial and emotional effects are
widespread and may have an impact on quality of life.
Approximately 34% of diabetics have onychomycosis.2 Diabetics
are at increased risk to develop complications secondary to
onychomycosis.5,6,7 Dermatophyte infected nails can form thick,
jagged edges that can injure the surrounding skin creating foot
ulcers.5,6,8 In diabetics with associated sensory neuropathy ulcerations
can go undetected precipitating secondary bacterial
complications that can be life threatening (sepsis) or require
amputation of the lower extremities. Onychomycosis results in
a three-fold increase in relative risk for developing gangrene in
diabetic patients,5 creating a treatment imperative.
There are numerous risk factors associated with onychomycosis,
including age, family history, male gender, and diabetes
(Table 1). Adults are most commonly affected by onychomycosis
secondary to slower nail growth. Some individuals are
genetically predisposed to onychomycosis.5 The toenails are
affected more often than the fingernails, likely due to slower
nail growth, increased exposure to organisms and an increased
prevalence of injury.5 Additionally, athlete’s foot often precedes
toenail infection. The most common fungal infections of the nail