Onychomycosis: Does Cure Equate to Treatment Success?

BACKGROUND: There is no general agreement as to what constitutes cure or treatment success in onychomycosis. Regulatory guidelines differ in the United States and Europe, and outcomes reported in clinical trials do not consistently report secondary endpoints.
METHODS: We reviewed definitions of onychomycosis cure to develop a less stringent and more practical approach to assess improvement and treatment success.
RESULTS: Complete cure (totally clear nail and mycologic cure) remains an important regulatory standard. Mycologic cure (negative fungal culture and negative potassium hydroxide) is the only consistently reported outcome in clinical trials, however the potential for discrepancies between microscopy and culture can be problematic. We propose a more practical approach to assessing improvement in infected nails that relies on both physician and patient input in a similar fashion to other skin diseases.
CONCLUSIONS: Treatment success should be based on both physician and patient assessment of improvement in the affected toenails and negative fungal culture.

J Drugs Dermatol. 2016;15(5):626-632.

Efinaconazole Topical Solution, 10%: Efficacy in Patients with Onychomycosis and Coexisting Tinea Pedis.

BACKGROUND: We sought to evaluate the efficacy of efinaconazole topical solution, 10%, in patients with onychomycosis and coexisting tinea pedis. METHODS: We analyzed 1,655 patients, aged 18 to 70 years, randomized (3:1) to receive efinaconazole topical solution, 10%, or vehicle from two identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary end point was complete cure rate (0% clinical involvement of the target toenail and negative potassium hydroxide examination and fungal culture findings) at week 52. Three groups were compared: patients with onychomycosis and coexisting interdigital tinea pedis on-study (treated or left untreated) and those with no coexisting tinea pedis. RESULTS: Treatment with efinaconazole topical solution, 10%, was significantly more effective than vehicle use irrespective of the coexistence of tinea pedis or its treatment. Overall, 352 patients with onychomycosis (21.3%) had coexisting interdigital tinea pedis at baseline, with 215 of these patients (61.1%) receiving investigator-approved topical antifungal agents for their tinea pedis in addition to their randomized onychomycosis treatment. At week 52, efinaconazole complete cure rates of 29.4% were reported in patients with onychomycosis when coexisting tinea pedis was treated compared with 16.1% when coexisting tinea pedis was not treated. Both cure rates were significant compared with vehicle (P = .003 and .045, respectively), and in the latter subgroup, no patients treated with vehicle achieved a complete cure. CONCLUSIONS: Treatment of coexisting tinea pedis in patients with onychomycosis enhances the efficacy of once-daily topical treatment with efinaconazole topical solution, 10%.

The use of focused electronic medical record forms to improve health-care outcomes.

BACKGROUND: We tested the use of specifically designed electronic medical record forms, thereby demonstrating the ability to electronically capture, report, and compare clinical data. To that end, podiatric physicians can determine what constitutes the most effective program or treatment for specific conditions by documenting their treatment outcomes. METHODS: A prospective case series was initiated to determine the value of using focused electronic medical record forms to track walking programs in the practices of podiatric physicians. Three patients were observed for 48 weeks using focused electronic medical record forms to input data (body mass index, cholesterol level, hemoglobin A(1c) level, blood pressure, and other vital information). Patients were given pedometers so that they could log their mileage and their podiatric physicians could enter it into the medical record. Information was collected using an electronic medical record system with the ability to link multiple templates together and assign logic to create flexible entry completion requirements. The clinical data generated are captured in a common database, where the data offer future opportunity to compare statistics among a multitude of practices in various demographic regions. RESULTS: Focused electronic medical record forms were effectively used to track improvements and overall health benefits in a walking program supervised by podiatric physicians. CONCLUSIONS: Valuable information can be ascertained with focused electronic medical record forms to help determine treatment effectiveness. This information can later be compared with practices across many different demographics to ascertain the best evidence-based practice.