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2. • Fungal infection of the nail unit:
nail plate, nail bed, and periungual
tissue1,2
– Causes discoloration, thickening, and
separation from nail bed2
– May lead to permanent damage of nail
plate and attachments3
• May be associated with significant
clinical issues3
• Progressive condition that warrants intervention3
Toenail Onychomycosis
1. Thomas J et al. J Clin Pharm Ther. 2010;35(5):497-519
2. Rich P et al. Semin Cutan Med Surg. 2013;32(2 Suppl 1):S5-8
3. Pariser D. Semin Cutan Med Surg. 2013;32(2 Suppl 1):S1
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Copied Or Left With Health Care Professionals.
3. T. rubrum Is the Most Common
Cause
1. http://phil.cdc.gov/phil ID#11009; ID#14588
2. Scher RK et al. Semin Cutan Med Surg. 2013 ;32(2 Suppl 1):S2-4
T. rubrum is responsible for
90% of onychomycosis2
Trichophyton rubrum1 Less common causative
organisms2:
• Other Trichophyton spp
• Microsporum canis
• Epidermophyton floccosum
• Acremonium spp
• Fusarium spp
• Scopulariopsis spp
• Scytalidium spp
• Aspergillus spp
• Candida spp
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4. • ZAIAS Classification
– Distal (lateral) subungual onychomycosis (DSO/DLSO)
– White superficial onychomycosis (WSO)
– Proximal subungual onychomycosis (PSO)
– Candida onychomycosis
Clinical Presentation &
Classification
1. Zaias, N. Onychomycosis. Arch Dermatol. 1972; 105: 263–274
2. Hay RJ, Baran R. JAAD. 2011; 65(6): 1219–1227
1972
– Totally dystrophic onychomycosis (TDO)1981
– Endonyx onychomycosis1999
– Mixed pattern onychomycosis (MPO)
– Secondary onychomycosis
2011
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5. Diagnosis
Onychomycosis?
Psoriasis! Looks like onychomycosis with distal thickening of the nail with
some onycholysis, but the patient has psoriasis AND history of nail trauma
which might have koebnerized the nail.
Courtesy of B. Elewski, Professor of Dermatology, UAB
For Presentation Purposes Only. Not To Be
Copied Or Left With Health Care Professionals.
6. Diagnosis
Differential diagnosis (adults):1
• Psoriasis
• Nail trauma
• Exogenous substances
(eg. Nail polish, medications)
• Lichen Planus
• Neoplasms
• Infection (bacterial)
• Aging
Clinical Diagnosis:1
• Physical examination
• Concomitant tinea
pedis
• Family history
• Age
Lab confirmation:1
• KOH, culture, PAS, PCR1,2
1. Rich P et al. Semin Cutan Med Surg. 2013;32(2 Suppl 1):S5-8
2. Westerberg DP, Voyack MJ.et al. Am Fam Physician. 2013;88(11):762-70
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Copied Or Left With Health Care Professionals.
7. Predisposing Factors
• Gender (male)
• Age
• Smoking
1. Thomas j et al. J Clin Pharm Ther. 2010;35(5):497-519
2. Scher RK et al. Semin Cutan Med Surg. 2013 ;32(2 Suppl 1):S2-S4
• Occlusive shoes
• Public sports
facilities/gyms
• Nail salons
• Poor foot hygiene
• Concurrent fungal
infection
(eg. Tinea pedis)
• Diabetes/Peripheral
vascular disease
• Nail trauma
• Immune deficiency
• Genetics
• Humid and warm
Demographics1,2 Lifestyle/
hygiene1,2
Medical
Condition1,2
Climatic
Conditions1,2
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8. Demographics of Those Seeking Rx
Treatment*
1. NDTI data, September 2013
63% of patients are less than 55 years old1
0%
5%
10%
15%
20%
25%
< 20 20-24 25-34 35-44 45-54 55-64 ≥65
MALE
PATIENTS
49.1%
FEMALE
PATIENTS
50.9%
50% of patients female/male1
Treatment seekers* are balanced male vs. female,
and across diverse age groups
* Data refers to Lamisil users
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9. • It is an infection…a fungal infection
• Progressive condition1
• Permanent damage to nail plate and
attachments1
• Transmission to other body parts and/or other
people1,2
Toenail Onychomycosis:
Importance of Treatment
1. Pariser D. Semin Cutan Med Surg. 2013;32(2 Suppl 1):S1
2. Thomas J et al. J Clin Pharm Ther. 2010;35(5):497-519
For Presentation Purposes Only. Not To Be
Copied Or Left With Health Care Professionals.
10. Toenail Onychomycosis:
Goals of Treatment
Eliminate causative agent1*
Elewski B et al. Semin Cutan Med Surg. 2013 ;32(2 Suppl 1):S9-12
Restore appearance of toenail(s)1*
Pharmacological: Physiological (Nail growth):
* Results may vary
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11. Oral Rx Products
• Itraconazole capsules and tablets
• Terbinafine tablets
Topical Rx Products
• Efinaconazole topical solution
• Tavaborole topical solution
• Ciclopirox topical solution
OTC Products
Homeopathic Products
Laser Treatment
Toenail Onychomycosis:
Current “Treatment” Options
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12. • Application to site of infection
• No known drug interactions at
therapeutic concentrations
• No liver monitoring needed
Characteristics of Topical Antifungal
Therapy
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14. Summary
• T. rubrum is the most common cause, responsible for
90% of cases
• A frequent and increasing problem
• Both females and males, and patients of all ages seek
treatment
• A significant clinical burden – warrants treatment
• Treatment goals: elimination of fungus & improved
toenail(s) appearance
• Effective topical therapy may be appropriate for
treatment of toenail onychomycosis
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Editor's Notes
Onychomycosis is defined as a fungal infection of the nail unit, including the nail plate, nail bed, and periungual tissue
This fungal infection causes discoloration, thickening, and separation from the nail bed
Untreated, onychomycosis may lead to permanent damage of the nail plate and its attachments, and it may be associated with significant clinical issues
For the reasons stated here, and considering onychomycosis is usually a progressive condition, it warrants intervention
References:
Thomas J, Jacobson GA, Narkowicz CK, Peterson GM, Burnet H, Sharpe C. J Clin Pharm Ther. 2010;35(5):497-519
Rich P, Elewski B, Scher RK, Pariser D. Semin Cutan Med Surg. 2013 ;32(2 Suppl 1):S5-8
Pariser D. Semin Cutan Med Surg. 2013 ;32(2 Suppl 1):S1
The most common organisms found in onychomycosis are Trichophyton rubrum, which is responsible for an estimated 90% of infections, and Trichophyton mentagrophytes, which is implicated most commonly in the remainder of cases.
Microsporum spp and Epidermophyton floccosum are unusual causes of onychomycosis in the United States.
A number of other organisms also may be involved in fungal nail infections, [upon CLICK] including some nondermatophyte molds, such as Fusarium and some yeasts—[upon CLICK] especially Candida spp.
References:
Scher RK, Rich P, Pariser D, Elewski B. Semin Cutan Med Surg. 2013 ;32(2 Suppl 1):S2-4
The first classification of onychomycosis was proposed by Zaias (1972), and is based on the clinical appearance and pattern of nail plate invasion. He described four clinical types:
distal (lateral) subungual onychomycosis (DSO/DLSO): where invasion originates from the distal and lateral undersurface of the plate
white superficial onychomycosis (WSO): where invasion originates from the upper surface
proximal subungual onychomycosis (PSO): where the attack starts from the undersurface of the proximal nailfold
Candida spp. onychomycosis
In 1981, Baran et al. introduced the concept of totally dystrophic onychomycosis (TDO) to explain the fact that, in some patients, the nail plate and, often, surrounding periungual tissue may be involved by the infection
In 1999, Tosti et al. introduced the concept of endonyx onychomycosis to describe the condition where the nail plate is attacked from the distal end of the nail plate causing deeper penetration of fungal hyphae
In 2011, Baran et al. proposed a further expansion of the classification of onychomychosis to include
Mixed pattern onychomycosis (MPO): whereby multiple forms can exist on the same nail
Secondary onychomycosis: whereby the fungal infection arises secondary to other conditions such as psoriasis or keratoderma
The authors proposed, although it can be associated with chronic mucocutaneous candidosis, candida may not be a true primary nail pathogen.
References:
Zaias, N. Onychomycosis. Arch Dermatol. 1972; 105: 263–274
Hay RJ, Baran R. JAAD. 2011; 65(6): 1219–1227
Differential diagnosis of onychomycosis needs to be established. Other diseases have clinical presentations that may be confused for onychomycosis.
Does this patient have onychomycosis?
No. This patient has psoriasis. Looks like onychomycosis with distal thickening of the nail with some onycholysis, but the patient has psoriasis AND history of nail trauma which might have koebnerized the nail.
References:
Patient case and diagnosis provided by Boni Elewski, Professor of Dermatology, UAB
Onychomycosis can mimic many other clinical conditions that affect the nail, such as:
Psoriasis
Trauma
Exogenous substances (eg. Nail polish, medications)
Lichen planus
Neoplasms
Other nail infection (bacterial)
Aging
The diagnosis of onychomycosis is suggested by the clinical presentation as well as the family history and patient age. Concomitant tinea pedis infection is extremely common in patients with toenail onychomycosis. The diagnosis of onychomycosis should be confirmed prior to the initiation of therapy using an office/laboratory test including:
Potassium hydroxide (KOH) preparation
Fungal culture
Periodic-acis Schiff (PAS) staining
Polymerase Chain Reaction (PCR)
KOH of subungual debris and periodic-acid Schiff (PAS) staining of nail plate samples provide confirmation of organisms but do not identify or ascertain the viability of organisms present. Culture is slower and less sensitive but currently is the standard method for identifying the causative
organism. Polymerase chain reaction may become a useful method but is not yet widely available.
The gold standard of diagnosis for onychomycosis remains the fungal culture. Culturing is the only method that is widely available at this time that provides definitive identification of a specific organism.
References:
Rich P et al. Semin Cutan Med Surg. 2013;32(2 Suppl 1):S5-8
Westerberg DP, Voyack MJ.et al. Am Fam Physician. 2013;88(11):762-70
Onychomycosis is reported to be more prevalent in the elderly and appears to occur more frequently in males, as well as among smokers
Onchomycosis is a topic of concern among several patient populations, including those with poor peripheral circulation, those with diabetes, and those with compromised immune function
Recent studies also suggest a genetic factor in susceptibility to onychomycosis, meaning family history may influence susceptibility to onychomycosis
Other factors are known to increase the risk for developing onychomycosis, including
Heavy perspiration
Humid and moist environments
Occlusive footwear
A history of nail trauma
Walking barefoot in public places such as pools or gyms where moisture is prevalent
Frequenting nail salons
References:
Thomas J, Jacobson GA, Narkowicz CK, Peterson GM, Burnet H, Sharpe C. J Clin Pharm Ther. 2010;35(5):497-519
Scher RK, Rich P, Pariser D, Elewski B. Semin Cutan Med Surg. 2013 ;32(2 Suppl 1):S2-4
Although male gender and increasing age are predisposing factors for increased incidence of onychomycosis, according to NDTI data on patients who went on to use Lamisil:
63% of patients who went on to use Lamisil were less than 55 years old
Equal proportion of men and women
References:
NDTI data, September 2013
Onychomycosis is an infectious disease of significant importance, and few providers would consider the infection too trivial to treat, even if the initial presentation appears mainly cosmetic - onychomycosis is often a progressive condition that warrants intervention
Consequences of untreated onychomycosis include permanent damage to the nail plate and its attachments, local spread of the infection or spread to other parts of the body, transmission of the infection to others, and other clinical issues
References:
Pariser D. Semin Cutan Med Surg. 2013 ;32(2 Suppl 1):S1
Thomas J, Jacobson GA, Narkowicz CK, Peterson GM, Burnet H, Sharpe C. J Clin Pharm Ther. 2010;35(5):497-519
The goal of treatment of onychomycosis of the toenails is to eliminate the causative organism
Elimination of the fungus sets the stage to restore the appearance of the toenail(s)
However, it is important to note that treatment outcomes for onychomycosis are a product of two factors: the pharmacology of the drug prescribed – that is it’s ability to eliminate the causative agent (ie. fungus), and physiology - the body’s ability to restore the appearance of the infected toenail(s) via growth of the nail(s)
Patients should not expect to see improvement in toenail(s) appearance until after the fungi are eliminated and until the damaged nail has grown out—a process that, for toenails, may take 12 to 18 months or longer. Individual results may vary.
References:
Elewski B, Pariser D, Rich P, Scher RK. Semin Cutan Med Surg. 2013;32(2 Suppl 1):S9-12
“Treatment” options for toenail onychomycosis include:
Prescription oral antifungals: include itraconazole capsules (eg. Sporanox) and terbinafine tablets (eg. Lamisil)
Prescription topical antifungals: include efinaconazole topical solution (eg. Jublia); tavaborole topical solution (eg. Kerydyin); ciclopirox topical solution (eg. Penlac)
OTC products: anecdotally, some patients may be trying OTC products, there are no OTC products approved by the FDA for the treatment of onychomycosis
Homeopathic products: anecdotally, some patients may be trying homeopathic products, these are not approved by the FDA for the treatment of onychomycosis, and little if any clinical data is available to support the safety and efficacy of these agents for the treatment of onychomycosis
Devices: – which include lasers. Several lasers have been granted FDA marketing approval for the temporary improvement in the appearance of the nail. It is important to note that regulatory clearance of device systems are made on the basis of "substantial equivalence" to the technical specifications of pre-existing devices approved for marketing for onychomycosis, not on the basis of clinical trials data, so these systems cannot be directly compared to pharmacologic therapies1.
References:
Gupta AK, Simpson F. Skin Therapy Letter 2012; 17(9): 4-9
The characteristics of topical antifungal therapy include
Application to site of infection
No known drug interactions at therapeutic concentrations
No liver monitoring needed