An Overview of Onychomycosis (Nail Fungus) and New Laser Treatment Options

Onychomycosis (nail fungus) affects approximately 7-10% of the adult population. Although not associated with morbidity and mortality, it can be painful and often associated with psychosocial problems due to thick, discolored, and/or disfigured nails. Treatment has been limited to oral anti-fungal medications with a significant propensity for side effects and re-occurrence. Recently, the use laser energy show promising signs of safely and effectively treating this difficult condition. This article describes the causes, risk factors, differential diagnoses, and treatments for nail fungus, including the newest modality- laser treatment.

Causes:

Onychomycosis or “Tinea unguium” is a common nail disease usually caused by a dermatophyte (skin fungi). Other causes include Candida species (yeast) and non-dermatophyte molds. The most common pathogen is Trychophyton Rubrum, which accounts for ~80% of all cases. T. Rubrum also causes athlete’s foot (Tinea pedis), therefore, both conditions should be treated simultaneously if evidence of both are found.

Other causative dermatophytes include Epidermophyton Floccosum and Trichophyton Mentagrophytes. Fungi thrive in warm, humid environments, therefore, are difficult to eradicate once embedded in and under the nail plate. Fungi also secrete enzymes that breakdown nail keratin, resulting in “subungual hyperkeratosis” or excess keratinous matter under the nail. Infected nails appear thick, porous, discolored (usually yellow, brown, or white), flakey, cloudy and/or crumbly.

Nail plates can become infected as a result of blunt trauma (sudden) or micro trauma (gradual). In either case, the protective peripheral barrier around the nail is damaged, thereby allowing the entry of pathogenic organisms. However, onychomycosis can occur spontaneously without symptoms, known trauma, or concurrent athlete’s foot. Onychomycosis is also a common cause of nail dystrophy and onycholysis. Nail dystrophy is defined as “misshapen or partially destroyed nail plates”. Onycholysis , or “separation of the nail from the nail bed” is a commonly associated with dystrophic nails.

Risk Factors:

Risk factors for onychomycosis include: Increasing age, male gender, diabetes, nail trauma,
hyperhidrosis (excess perspiration), peripheral vascular disease, poor hygiene, Tinea pedis, or immunodeficiency. Onychomycosis affects approximately 50% of men over the age of 40 and is rarely seen in children and adolescents.

Differential Diagnoses:

Fungal infections only account for about 50% of nail dystrophy (destroyed or damaged nail plate). Differential diagnoses include: Psoriasis, lichen planus, contact dermatitis, traumatic onychodystrophies, congenital pachyonychia, bacterial infection, yellow nail syndrome, idiopathic ohycholysis, or onychogryphosis. A detailed description of these diagnoses is beyond the scope of this article. Therefore, readers are encouraged to consult their health care provider and/or research as needed.

Traditional Treatments:

Historically, onychomycosis has been difficult to treat due to the time required for nail growth, the inability to penetrate the hard nail with effective medicinal treatment, and the overall virulence of the causative pathogen.

For decades, griseofulvin was the only oral antifungal available. However, its effect was limited due to a weak antifungal spectrum and poor pharmacokinetic profile. Cure rates were low and reoccurrence was common. The newer generation oral antifungal agents, terbinafine and itraconozole, have improved antifungal activity and more favorable pharmacokinetics. Both agents are absorbed into the nail matrix following recommended courses of oral administration. However, both are associated with liver toxicity (hepatotoxicity) and cannot be administered with other medications metabolized by the same liver enzymatic system. Consequently, liver function tests are usually recommended every 4-6 weeks. Itraconazole is also contraindicated for patients with congestive heart failure.

In studies, these oral therapies yielded marginal clinical cure rates of 30-50%. Clinical relapse is also common as medication concentrations in the nail bed drop below the minimum concentration required to eliminate residual dermatophyte spores. Only one viable spore can re-germinate and lead to clinical relapse.

Most topical antifungals are simply ineffective against onychomycosis. Most lack a keratin soluble (oil or lipid based) carrier required to actually penetrate the nail plate and reach the site of infection. Also, many topical antifungals have limited activity against a potentially broad spectrum of causative pathogens. Over-the-counter (OTC) antifungals may (at best) treat fungus on nail plate surfaces and adjacent soft tissues.

Cleare Nails PRO is an innovative topical antifungal developed in 2011. Clear Nails PRO contains a blend of three potent antifungals (6% ciclopirox, 6% terbinafine, and 2% fluconazole), which act synergistically. This compounded agent features a patented, nail penetrating carrier system, a proprietary blend of botanicals which allow the suspended medications to be carried deep into the nail matrix. Clear Nails PRO is used exclusively by Laser Treatment Specialists in Centennial, CO (see author’s bio).

Other topical antifungals include Penlac (8% ciclopirox) and Formula 3 (1% tolnaftate). Both antifungals have the disadvantage of a single medication. Prescription Penlac must be used for several months and has about 10% efficacy. Formula 3 also features a nail penetrating base, however, contains a low concentration of active drug.

Alternative (Laser) Treatments:

Recently, the clinical use of laser energy has attracted increasing attention. There are currently several technologies and treatment plans being promoted as safe and effective alternatives to oral and topical medications. These lasers emit various wavelengths with corresponding mechanisms of fungal de-activation. Here are some examples:

The “CoolTouch CT3+” ND:YAG 1320nm by New Star Lasers is a mid infrared, gold-standard skin laser. The CT3+ has inherent advantages for nail fungus treatment, as nails are simply modified skin. 1320nm energy is absorbed entirely by water, resulting in thermal necrosis (killing by heat) of fungal infections in the nail matrix (water vaporization is vital in laser nail fungus treatment). The laser spot size is variable from 3mm-10mm, which allows precise and uniform treatments by controlling beam width and depth of penetration according to nail size. The thermal sensor allows the operator to monitor and optimize the treatment temperature in real-time. The cryogen feature manually or automatically cools the treatment surface with a compressed gas for patient comfort and thermal shock effect. The CoolTouch laser allows superior control of key treatment parameters. The CoolTouch CT3+ is FDA cleared for use in general podiatry and dermatology, and currently under investigation for onychomycosis. The CoolTouch CT3+ laser is used exclusively by Laser Treatment Specialists in Centennial, CO (see author’s bio).

The “Pinpointe” ND:YAG 1064nm is a modified mid-infrared dental laser. 1064nm is a versatile wavelength used for dark hair removal, dark ink tattoo removal, collagen remodeling, and enlarged pore reduction. 1064nm energy is absorbed by melanin (skin pigment), hemoglobin (protein in red blood cells) and water. The Pinpointe is simple to operate and widely marketed. However, it lacks a thermal sensor; thus treatment temperatures cannot be monitored. It also has a 1.5mm fixed spot size and no cooling function. The Pinpointe is FDA “cleared for temporary increase in clear nail”, an indication which has NO bearing on safety and efficacy. See end of article for more information on FDA “clearance” vs. “approval”. Reference: http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194460.htm

The “Noveon” laser by Nomir Medical is a near-infrared diode laser which delivers dual wavelengths (870nm and 930nm) exerting a “photo-inactivation” mechanism of action against fungal pathogens. The Noveon features electronic probes attached to infected toes. The automated process does not require a laser operator to administer the procedure. The Noveon is FDA cleared for general podiatry and dermatology and also under investigation for onychomycosis.

As of early 2013, numerous lasers have flooded the market, each claiming to be safe and effective for nail fungus treatment. Bear in mind: The laser alone will not insure optimal outcomes. The laser operator’s skill, experience, and collateral treatment parameters are of vital importance.

Conclusion:

Once nail fungus sets in, spontaneously resolution is rare. As the nail plate has no blood supply, there is no immune response. Therefore, nail fungus usually worsens as fungal growth gradually exceeds nail growth. The ideal time to begin treatment is at the first sign of infection and/or a positive nail culture.

Nail fungus treatments are neither equivalent nor interchangeable. This condition is inherently difficult to treat and prevent from re-occurring. High overhead medical clinics are generally expensive and profit oriented (vs. clinically oriented). As a result, outcomes may be compromised with inadequate technique, laser, and # of treatments. Physicians, Podiatrists and other “western” practitioners routinely treat nail fungus with prescription oral medication (i.e, Lamisil (terbinafine) 250mg QD for 90 days), which often requires monthly liver functions tests. This antiquated process of repeated office & pharmacy visits is inefficient, relatively ineffective, and potentially dangerous.

A popular alternative is treatment by a CLS (Certified Laser Specialist) that specializes in nail fungus. Modern medical aesthetic lasers are safe and effective. This laser energy is non-ionizing, non-mutating, and allows targeted treatment at the site of infection.

Consider the following if you are researching the most cost-effective treatment:

  • Does the clinic specialize in laser nail fungus treatment?
  • Does the clinic have substantial treatment photos and patient testimonials?
  • How many separate treatments are performed and in what intervals?
  • How many passes per nail/per treatment and how are treatment endpoints determined?
  • What topical medications are used, if any? (Combining a nail penetrating, medicinal topical with laser treatment is inexpensive, safe, and “standard of care” for best outcomes)
  • What is the wavelength of the laser and what is the energy absorbed by? (water, hemoglobin, melanin, etc)
  • Are treatment rates for one visit or a comprehensive package? (Avoid “fixed price, single treatment” plans which are clinically and economically unfavorable)

For more information from the author, please call, visit our website, or arrange a free consultation/evaluation with Laser Treatment Specialists in Centennial, CO. Contact information located in author’s bio.

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Important note on FDA “approval vs. clearance” of medical devices:

If a laser is promoted as “FDA approved”, validate by requesting documentation, specifically the FDA definition of “approval” vs. “clearance”. Many clinics falsely advertise their laser as “approved” for nail fungus, while the device may only be “cleared for temporary increase in clear nail”.

FDA clearance only requires “substantial equivalence” to existing devices legally marketed for the same use. FDA approved devices are evaluated based on safety and efficacy. Refer to http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194460.htm for more information.