Boni E Elewski1, Antonella Tosti2, Tina Lin3. 1. Department of Dermatology, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA. 2. Department of Dermatology and Cutaneous Surgery, Leonard Miller School of Medicine University of Miami, Miami, FL, USA. 3. Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, USA.
Abstract
BACKGROUND: Clinical studies with topical onychomycosis agents typically involve daily application over 48 weeks. Some patients are cured earlier; however, individual data are limited. OBJECTIVE: The aim of this study was to assess baseline demographics/disposition of onychomycosis patients completely cured at week 24 following daily efinaconazole treatment. METHODS: We conducted a week-24 case review of 2 identical, multicenter, randomized, double-blind, vehicle-controlled studies on 1,655 patients with mild-to-moderate onychomycosis. Patients were randomized (3:1) to efinaconazole 10% solution or vehicle, once daily for 48 weeks, with a 4-week post-treatment follow-up. Complete cure was defined as 0% clinical involvement of the target toenail and mycological cure (negative KOH examination and fungal culture). RESULTS: Overall, 19 patients had clear nails (0% clinical involvement) at week 24, and 13 (68%) were completely cured. Patients were predominantly younger (17/19 aged <65 years), female (12/19), and with recent disease (6/12). No patient had disease recurrence over the subsequent 28 weeks. Complete cure appeared independent of baseline severity. Two patients with moderate disease had clear nails by week 12, and 1 experienced recurrence. CONCLUSIONS: Efinaconazole 10% topical solution has been shown to be an effective and well-tolerated treatment for onychomycosis. Our case review highlights that some patients (typically those having faster growing, shorter nails) might expect complete cure within 24 weeks. Continued treatment appears to prevent recurrence.
BACKGROUND: Clinical studies with topical onychomycosis agents typically involve daily application over 48 weeks. Some patients are cured earlier; however, individual data are limited. OBJECTIVE: The aim of this study was to assess baseline demographics/disposition of onychomycosis patients completely cured at week 24 following daily efinaconazole treatment. METHODS: We conducted a week-24 case review of 2 identical, multicenter, randomized, double-blind, vehicle-controlled studies on 1,655 patients with mild-to-moderate onychomycosis. Patients were randomized (3:1) to efinaconazole 10% solution or vehicle, once daily for 48 weeks, with a 4-week post-treatment follow-up. Complete cure was defined as 0% clinical involvement of the target toenail and mycological cure (negative KOH examination and fungal culture). RESULTS: Overall, 19 patients had clear nails (0% clinical involvement) at week 24, and 13 (68%) were completely cured. Patients were predominantly younger (17/19 aged <65 years), female (12/19), and with recent disease (6/12). No patient had disease recurrence over the subsequent 28 weeks. Complete cure appeared independent of baseline severity. Two patients with moderate disease had clear nails by week 12, and 1 experienced recurrence. CONCLUSIONS: Efinaconazole 10% topical solution has been shown to be an effective and well-tolerated treatment for onychomycosis. Our case review highlights that some patients (typically those having faster growing, shorter nails) might expect complete cure within 24 weeks. Continued treatment appears to prevent recurrence.
Entities:
Keywords:
Case review; Efficacy; Efinaconazole; Onychomycosis; Topical solution
Authors: Boni E Elewski; Phoebe Rich; Richard Pollak; David M Pariser; Shinichi Watanabe; Hisato Senda; Chikara Ieda; Kathleen Smith; Radhakrishnan Pillai; Tage Ramakrishna; Jason T Olin Journal: J Am Acad Dermatol Date: 2012-11-20 Impact factor: 11.527
Authors: Thomas D Pollard; Margherita Bonetti; Adam Day; Simon Gaisford; Mine Orlu; Abdul W Basit; Sudaxshina Murdan; Alvaro Goyanes Journal: Pharmaceutics Date: 2022-02-19 Impact factor: 6.321