Studies Cite Benefits Of Tavaborole For Onychomycosis

Two recent phase III studies point to a new topical agent as an effective treatment option for onychomycosis.

The studies, published in the Journal of the American Academy of Dermatology, focused on the use of tavaborole (Kerydin, PharmaDerm) for adults with distal subungual onychomycosis affecting 20 to 60 percent of a great toenail. By a 2:1 ratio, patients received either tavaborole or a vehicle treatment once a day for 48 weeks.

In regard to primary endpoints at week 52, 6.5 and 9.1 percent of tavaborole patients achieved complete cure in the two studies in contrast to 0.5 and 1.5 percent of vehicle patients. Additionally, negative mycology rates were 31.1 and 35.9 percent for tavaborole patients in the two studies in comparison with 7.2 and 12.2 percent of vehicle patients. Among the secondary endpoints for the studies, a completely or almost clear nail occurred in 26.1 and 27.5 percent in tavaborole patients and in 9.3 and 14.6 percent of vehicle patients.  

Tavaborole shows promising study results and is a first in its class antifungal agent based on the boron atom’s unique affinity for blocking fungal tRNA synthetase, according to Myron Bodman, DPM, an Associate Professor at the Kent State University College of Podiatric Medicine. He says the reported 26.1 to 27.5 percent of tavaborole-treated patients having completely or almost completely clear nails “should satisfy both patients and clinicians.”

Dr. Bodman adds that applying the most stringent FDA standards of 100 percent completely clear nails plus negative KOH and negative culture still yielded a 15 to 18 percent cure rate for tavaborole. He points out that this is almost triple the improvement of the previously FDA approved ciclopirox nail lacquer.

Tavaborole “holds significant promise” in treating onychomycosis, says Kristine Hoffman, DPM, FACFAS. While noting that the mycologic and complete cure rates for tavaborole are modest, Dr. Hoffman says the medication still has significantly higher success rates in comparison to ciclopirox 8% nail lacquer (Penlac). She points out that researchers evaluated the efficacy of tavaborole without concomitant nail debridement so the addition of debridement reducing nail plate thickness has the potential to increase the treatment success rates for the topical antifungal.

Additionally, patients can easily apply tavaborole via dropper, the medicine does not require periodic removal and patients can apply it over nail polish, according to Dr. Hoffman, who is in private practice in Boulder, Colo.

Dr. Hoffman most frequently treats onychomycosis with oral terbinafine (Lamisil, Novartis). However, she notes that due to illness, medication interaction or patient personal preference, Lamisil is often not a viable treatment option.

In Dr. Bodman’s experience, he has found the best results in managing onychomycosis involve a combination of oral terbinafine and topical efinaconazole (Jublia, Valeant Pharmaceuticals), tavaborole, ciclopirox and laser therapy. He adds that debridement can improve patient satisfaction quicker than medication alone.

Dr. Bodman notes that tavaborole performs better than ciclopirox nail lacquer or laser therapies alone but that oral terbinafine and topical efinaconazole still outrank tavaborole when it comes to the percentages of patients with totally clear nails and negative mycology, according to recent studies. He points out that patients generally prefer a topical solution over an oral antifungal treatment.

“Tavaborole offers a viable alternative for patients who are not candidates for or who wish to avoid oral antifungal medications,” says Dr. Hoffman. “Topical antifungals with higher success rates and shorter treatment courses are strongly needed.”

“Clinicians and patients are still in need of even more efficacious topical solutions,” adds Dr. Bodman. “Novel treatments like tavaborole in combination with penetrating vehicles promise to further improve cure rates.”

Editor’s note: For a related article, see “An Update On Current And Emerging Topical Antifungals” at https://www.podiatrytoday.com/update-current-and-emerging-topical-antifungals .

Abstract Shows Melanoma Rates Up 253 Percent In 40 Years

By Brian McCurdy, Managing Editor

Since 1973, rates of melanoma have increased by 253 percent in young adults, according to an abstract presented at the American Society of Clinical Oncology Annual Meeting.

Authors focused on 35,726 cases of melanoma in patients under 40 from 1973 to 2011. The abstract found the incidence rate of melanoma per 100,000 increased from 13.26 to 46.79 with researchers noting that Caucasian females were at particular risk. The abstract authors note that 98.6 percent of cases were cutaneous and localized, and also detected an increasing trend in diagnosis at an earlier disease stage.

William Fishco, DPM, FACFAS, notes that patients have had education about melanoma as far as what to look for in a suspicious looking mole and there are better screening/prevention guidelines. He also notes that the running movement took off in the 1970s and 1980s, facilitating a probable increase in outdoor exercising and activity in the past 40 years. Other factors may be the popularity of tanning beds and a depleting ozone layer, according to Dr. Fishco, who is in private practice in Phoenix.

To prevent pedal melanoma, Dr. Fishco advises avoiding sunburns and the use of sandals and flip-flops. If patients’ feet are exposed to sunlight, he suggests using a water resistant high SPF sunscreen on feet, especially for those wearing sandals or flip-flops. If patients are swimming or getting their feet wet, they should make sure to reapply sunscreen frequently, notes Dr. Fishco.

As Dr. Fishco points out, other than dermatologists, DPMs are typically the only healthcare providers who carefully examine feet and have the training to look for pigmented skin lesions that have a suspicious looking appearance. He suggests biopsying lesions with the following characteristics: pigmented with an asymmetric border, larger than 6 mm, heterogeneous coloration and a recent change in shape. Dr. Fishco also emphasizes biopsies for patients with a history of skin cancers.

“No one would criticize a provider for being cautious for biopsying a lesion but on the contrary, to miss something could have disastrous consequences,” says Dr. Fishco.

Study: VAC Therapy Facilitates Lower Healthcare Costs Than Other NPWT Devices

By Brian McCurdy, Managing Editor

The use of one negative pressure wound therapy (NPWT) device can lead to lower healthcare costs, according to a recent study in Wounds.

As part of a retrospective analysis of a national claims database analysis, researchers evaluated total and wound-related costs such as hospital readmission rates for patients with chronic wounds who were treated with NPWT. They compared the use of VAC therapy (Acelity) in 12,843 patients with other forms of NPWT in 713 patients. The study also notes mean total healthcare costs were $80,678 per patient for the VAC therapy group at 12 months versus $111,212 for those receiving NPWT with other devices.

Significantly lower inpatient, emergency room and home care costs led to those lower total costs, according to the study. The study authors also note that hospital readmissions were lower for patients on VAC therapy.

Adam Isaac, DPM, most commonly uses the VAC therapy system. As Dr. Isaac notes, the VAC systems are very reliable, in wide use and have easy troubleshooting procedures.

“(VAC therapy) is the ‘granddaddy’ system that we all grew up learning about the value of NPWT with,” says Gary Rothenberg, DPM, the Director of Resident Training with the Miami VA Healthcare System.
“Anything we can apply to the wound that increases the rate of wound healing and decreases the likelihood of infection/re-infection is going to drive costs down and lower admission rates,” says Dr. Isaac, the Director of the Complex Foot Wound Clinic within the Mid-Atlantic Permanente Medical Group/Kaiser Permanente of the Mid-Atlantic States in Rockville, Md.

Dr. Isaac also cites the ultra-portable, mechanical SNaP device (Spiracur) and its advantages of small size and quiet operation. He notes the device is also available “off the shelf,” saying this can make a difference in the outpatient and ambulatory surgery setting. Dr. Rothenberg’s facility uses VAC therapy for inpatients and non-powered systems such as SNaP and PICO (Smith and Nephew) for outpatients.
Some advantages of VAC therapy are its clinical efficacy and management of heavily exudating wounds, according to Dr. Rothenberg. He also cites several advantages of non-powered NPWT systems, including improving quality of life factors such as sleep, faster application and easy concealment.

“I think the non-powered systems are an excellent bridge technology and we have used them to transition patients out of the hospital sooner,” says Dr. Rothenberg. “I like the idea of delivering 24/7 wound care with NPWT and the non-powered systems are easier for patients to manage in the outpatient setting.”