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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

Mycoses Sep 23, 2017

Schaller M, et al. - This study contemplated the 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). It was deduced that 85.7% of subjects preferred amorolfine versus 14.3% for urea/bifonazole. Local side effects with amorolfine (4.5%) compared to urea (27.3%) and bifonazole (15%) was reported in fewer individuals. Amorolfine 5% nail lacquer presented as a simple and convenient therapeutic choice. This could lead to improved patient adherence, thereby causing improved efficacy and patient satisfaction.

Methods

  • The eligible candidates were allocated into Study A and Study B.
  • Study A: Enrollees received amorolfine and ciclopirox on opposite feet for 12 weeks.
  • Study B: Members received amorolfine and urea/bifonazole on opposite feet for 6-7 weeks.
  • The analysis comprised of subject adherence as per label, treatment preference and questionnaire.

Results

  • Study A: More subjects adhered to amorolfine (85%) than to ciclopirox (60%) (P = .025).
  • Patient satisfaction was reported (95% vs 100%, respectively) and the treatments were balanced with regard to 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).

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