Patient‐reported outcomes from two randomised studies comparing once‐weekly application of amorolfine 5% nail lacquer to other methods of topical treatment in distal and lateral subungual onychomycosis

• Published in: Mycoses Vol. 60; no. 12; pp. 800 - 807
• Main Authors: Schaller, Martin, Sigurgeirsson, Bardur, Sarkany, Marlis
• Format: Journal Article
• Language: English
• Published: Germany Wiley Subscription Services, Inc 01.12.2017
• Subjects: Administration, Topical; Adult; Aged; Amorolfine; amorolfine 5% nail lacquer; Antifungal Agents - administration & dosage; Bifonazole; ciclopirox 8% nail lacquer; Cream; Drug Administration Schedule; Female; Foot Dermatoses - drug therapy; Foot Dermatoses - psychology; Humans; Imidazoles - administration & dosage; Lacquer - analysis; Male; Medication Adherence; Middle Aged; Morpholines - administration & dosage; Morpholines - analysis; Onychomycosis; Onychomycosis - drug therapy; Onychomycosis - psychology; patient adherence; Patient Reported Outcome Measures; Patient satisfaction; Patients; patient‐reported outcomes; Pyridones - administration & dosage; Urea; urea 40% ointment/bifonazole 1% cream; patient adherence; patient-reported outcomes; onychomycosis; amorolfine 5% nail lacquer; ciclopirox 8% nail lacquer; urea 40% ointment/bifonazole 1% cream
• ISSN: 0933-7407; 1439-0507
• DOI: 10.1111/myc.12676

Summary Patient adherence is a key consideration in the choice of a topical regimen for the treatment of onychomycosis. The objective of this study was to investigate patient‐reported outcomes (treatment utilisation, adherence and satisfaction) in onychomycosis treated with once‐weekly amorolfine 5% nail lacquer versus once‐daily ciclopirox 8% nail lacquer (Study A) or once‐daily urea 40% ointment/bifonazole 1% cream combination regimen (Study B). Study A: Subjects received amorolfine and ciclopirox on opposite feet for 12 weeks. Study B: Subjects received amorolfine and urea/bifonazole on opposite feet for 6‐7 weeks. Assessments included subject adherence as per label, treatment preference and questionnaire. Study A: More subjects adhered to amorolfine (85%) than to ciclopirox (60%) (P = .025). Overall, subjects were satisfied (95% vs 100%, respectively) and the treatments were balanced in terms of preference (50% vs 45%) at week 12. Study B: More subjects adhered to amorolfine dosage (81.8%) than to the dosage of the urea/bifonazole combination regimen (59.1%) (P = .096). At the end of study, 85.7% of subjects preferred amorolfine versus 14.3% for urea/bifonazole. Fewer subjects experienced local side effects with amorolfine (4.5%) compared to urea (27.3%) and bifonazole (15%). Amorolfine 5% nail lacquer offers a simple and convenient treatment option, which may result in improved patient adherence and consequently lead to improved efficacy and patient satisfaction.